Center for Addiction Medicine

Past Studies

The work of the Center is carried out through clinical trials that investigate causes of substance use disorders and investigate novel treatments. These findings in these studies often affect the way treatment is delivered in actual healthcare environments. Information about the studies that are no longer being conducted may be accessed through the list below.

For more information on current research, visit the Active Studies page.

Characterizing Proximal Risk for Depressive Symptoms and Suicidal Ideation with Acute Cannabis Use and Withdrawal Among Adolescents Using Ecological Momentary Assessment

Principal InvestigatorRandi Schuster, Ph.D., 2021—2022

Study Reference: ECOR

The goal of this project is to collect critical pilot data on proximal relationships between acute cannabis use and withdrawal on depressive symptoms and suicidal ideation using ecological momentary assessment among depressed adolescents.

Cognition and Adolescent Health

Principal Investigator: Randi Schuster, Ph.D., 2015—2022

Study Reference: NIH/NIDA 1K23DA042946-02

The purpose of this study is to determine whether there is cognitive dysfunction in adolescent cannabis use that persists in the short term (four days) after use but resolves with extended abstinence (30 days) compared to cannabis users who do not quit and non-using controls, as well as estimate the rate of cognitive improvement with cannabis abstinence as a function of time since last use and concentration of detectable cannabis metabolites in urine. This study will also examine whether genetic risk for ADHD and other psychiatric co-morbidities alters the rate of cognitive recovery with cannabis abstinence.

Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illnesses

Principal Investigator: A. Eden Evins, M.D., MPH, 2016—2021

Study Reference: PCORI 1504-30472

The aim of this study is to assess the effectiveness of two practical approaches to improving the health of people with mental illness in the community. The project will test whether tailored education to primary care doctors alone or combined with community health workers will help those with mental illness quit smoking. More than 1,100 patients in 50 Boston area community health clinics will be involved. Bay Cove Human Services and Vinfen, two of the largest mental health service providers in the Commonwealth, will lead the clinical component of this study.

Positive Psychology Smoking Cessation Smartphone App for Nondaily Smokers

Principal Investigator(s): Bettina Hoeppner, Ph.D., Susanne Hoeppner, Ph.D., Lourah Kelly, Ph.D., John F. Kelly, Ph.D. 2016—2021

Study Reference:  130323-RSG-17-021-01-CPPB

The goal of this project is to develop a smartphone app to support smoking cessation in nondaily smokers using a positive psychology approach.  A three-phase development process is proposed, using (1) in-depth feedback from n = 30 on our already developed Version 1.0, (2) a nation-wide pilot test of Version 2.0 (n = 90), and (3) a proof-of-concept randomized controlled trial (= 226).

Pilot Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults with Substance Use Disorder

Study Principal Investigator(s): Kate Bentley, Ph.D. 2018—2020

Training Grant Principal Investigator(s): A. Eden Evins, M.D., MPH & Nancy Rigotti, M.D.

Study Reference: NIH/NIDA 5K12DA043490 (Career Development Program)

The purpose of this pilot study is to examine the acceptability, feasibility, and preliminary efficacy of adding a transdiagnostic, emotion-focused, cognitive-behavioral group intervention to treatment as usual within a comprehensive outpatient addiction program for young adults (ages 18 to 26) with substance use disorder and co-occurring anxiety or depressive symptoms, suicidal ideation, or nonsuicidal self-injury. Participants (n = 50) are randomly assigned to receive the experimental group intervention plus treatment as usual or treatment as usual alone, and substance use (via timeline followback), anxiety and depressive symptoms, and emotion regulation indices are assessed at baseline and four and eight weeks after randomization.

The Impact of Medicaid Plans on Access to and Quality of SUD Treatment

Principal Investigator: Margarita Alegria, Ph.D. 2018—2021

Study Reference: NIH/NIDA 1R01DA044526-01A1

This project makes use of random assignment methods to study the effects of the structure of state Medicaid programs on access, patterns of care and outcomes of substance use disorder (SUD) care. It conducts stratified analysis by race/ethnicity, gender, and rurality to identify which programs and plans have better outcomes and if there are service disparities. It uses qualitative methods to help interpret results and suggest changes to policy and practice.

Vignette Study

Principal Investigator: John F. Kelly, Ph.D.

Privately Funded

This privately funded study looks at terminology and stigma, and how word choice may affect attitudes and perceptions.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 in Patients with Performance Anxiety

Principal Investigator(s): A. Eden Evins, M.D., MPH, 2021

Study Reference: Vanda Pharmaceutical

The purpose of the study is to evaluate the effect of an investigational drug called VQW-765 on symptoms associated with performance anxiety and to assess the safety of VQW-765. Performance anxiety is a type of anxiety disorder characterized by excessive fear, discomfort, and self-consciousness in a variety of social situations related to performing in front of others such as public speaking. This intense and persistent fear in performance situations can result in significant impairment in almost all facets of daily life, including social activities, relationships, work, and studies.

VQW-765 is an investigational drug. It is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). In order to evaluate the effects of VQW-765 on social anxiety disorder symptoms and the safety of VQW-765, approximately 220 subjects will be enrolled nationwide and randomly assigned to one of two study drug groups: one group will receive VQW-765, and the other group will receive placebo.

Cannabis Studies

Using Imaging to Assess Effects of THC on Brain Activity [Details]

Principal Investigator(s): Gilman, Evins, Maravic
Study Reference: NIH/NIDA 1R42DA043977-01

The goal of this project was to develop, test, and refine a method to accurately and reliably detect marijuana (MJ) impairment using a portable, user-friendly, non-invasive, brain-based modality. The development of a fair, reliable, quantitative biological marker that enables law enforcement officers to screen individuals whom they suspect are impaired from MJ will have highly significant public health importance.

The Effect of Cannabis on Cognition and Neuroimaging in those with Major Depressive Disorder [Details]

Principal Investigator(s): Gilman, 2017—2018
Study Reference: NIH/NIDA K01DA034093-04

The prevalence of use of MJ among those with Major Depressive Disorder (MDD) is unknown, but MDD is the third most common reason for individuals to seek medical MJ, after pain and insomnia. It is therefore of critical importance to understand the effects of MJ use and MDD on brain function, particularly in young adults. In this neuroimaging study, we investigated the neural correlates of emotion processing and neural activity in those with and without MDD and MJ use.

The Effect of Cannabis on Cognition and Neuroimaging in those with PTSD [Details]

Principal Investigator(s): Gilman, 2017—2018
Study Reference: NIH/NIDA K01DA034093-04

Post-traumatic stress disorder (PTSD) has the highest lifetime prevalence of all anxiety disorders (8-9%), shows high rates of comorbidity with MDD, and is a critical predictor of suicidality. Increasingly, PTSD patients are seeking alternative treatments to current interventions, many of which have not been proven to be effective and may in fact be harmful. The most pressing example of this is the increased prevalence of medical marijuana (MM) use among PTSD patients. While it is possible that MM use temporarily alleviates PTSD symptoms, such as stress responses, flashbacks and recurring traumatic memories/dreams, more data is needed to ensure that MM does not lead to negative outcomes, such as addiction or cognitive side effects. In this neuroimaging study, we investigated the neural correlates of emotion processing and neural activity in those with and without PTSD and MJ use.

Effect of Medical Marijuana on Neurocognition and Escalation of Use [Details]

Principal Investigator(s): Jodi Gilman , 2016—2020
Study Reference: 5K01DA034093

The purpose of this study is to evaluate the the effect of medical marijuana (MM) on a range of outcomes, including clinical symptoms, cognitive performance, brain function, and possible transition to cannabis use disorders (CUD), in adults who are interested in using medical marijuana to treat pain, insomnia, depression, or anxiety. We will conduct longitudal assessments over 6 months that will: (1) characterize the impact of MM on progression to CUD, as well as other indices of addiction such as increased tolerance and withdrawal among those who stop using MM, (2) assess, via daily dosing diaries, the effect of MM use patterns on use of other medications and perception of underlying disease symptomatology, (3) characterize the impact of MM on neurocognitive performance, including executive function, memory, attention, and decision-making and (4) examine evidence for impact of MM on brain function in the prefrontal cortex and reward regions.

Web-based Survey of Individuals Interested in Using Medical Marijuana [Details]

Principal Investigator(s): Gilman, 2015—2020
Study Reference: NIH/NIDA 1K01DA034093-01A

The aims of this study are to characterize the most common illnesses for which MM is sought, the reasons for seeking MM, reasons for hesitance to use and to characterize current marijuana use habits of those interested in using MM.

Cognition and Adolescent Health [Details]

Principal Investigator(s): Schuster, Gilman, Evins, 2015—2020
Study Reference: 5K01DA034093-03

The purpose of this study is to provide updated information on prevalence and frequency of cannabis use in relation to other forms of substance use in a representative sample of high-school aged adolescents, to evaluate the effect of contingency management on initial 30-day verified cannabis abstinence in adolescents and older adolescents who use cannabis at least weekly and are not seeking treatment, to determine whether there is cognitive dysfunction in cannabis use that persists in the short term (4 days) after use but resolves with extended abstinence (30 days) compared to cannabis users who do not quit and non-using controls and to estimate the rate of cognitive improvement with cannabis abstinence as a function of time since last use and concentration of detectable cannabis metabolites in urine.

Mentoring in Patient-Oriented Addiction Research [Details]

Principal Investigator(s): Kelly, 2014—2019
Study Reference: National Institute of Alcohol Abuse and Alcoholism/K24AA022136-01

This grant is designed to develop specific content expertise in treatment and recovery policy, and the design, implementation, and evaluation of treatment and recovery support service combinations. This grant also allows for mentoring junior investigators in patient-orientated addiction research (POAR).

Longitudinal Study of Neurocognitive Effects of Cannabis Use
Decision-Making and Drug Use [Details]

Principal Investigator(s): Gilman, 2013—2016
Study Reference: NIH/NIDA 1K01DA034093-01A1

The aim of the study is to design novel behavioral tasks that will allow us to separate and empirically measure factors that predict social influence. We would like to design new tasks based on classic psychological studies that will allows us to model social influence, to observe differences between non-dependent young adults aged 18-25 who use either alcohol (ALC) or marijuana (MJ), and age-matched controls (CON), in order to investigate differences in susceptibility to social influence and in neural activation of regions associated with social influence as a function of early drug use.

Internet ad for the Decision-Making and Drug Use Study

Using Imaging to Assess Effects of THC on Brain Activity [Details]

Principal Investigator(s): Gilman, 2013—2017
Study Reference: NIDA 1K01DA034093

The aim of this study is to assess the effects of THC intoxication using the medication dronabinol (synthetic THC) on resting state and task-based activation in the prefrontal cortex (PFC), as well as on neurocognitive task performance and correlations between these measurements and clinical signs of intoxication, as well as to investigate at which doses of dronabinol an effect on neurocognitive task performance or an effect on PFC activity can be observed.

Recovery Research Institute (RRI) [Details]

Principal Investigator(s): Kelly, 2011—2019
Study Reference: Tower Foundation and private donors

Some of the RRI projects include building and maintaining a website in order to provide a credible source of information to debunk addiction and recovery myths, and provide free access to the latest recovery research information; building and evaluating recovery support programs in the community; building and evaluating recovery support programs in educational settings such as high schools and colleges; understanding the impact of community mutual-help organizations; addiction treatment system program evaluation.

Mentoring in Addiction Treatment Research [Details]

Principal Investigator(s): Evins, 2010—2015
Study Reference: NIDA K24 DA030443

The major aim of this career award is to provide support for mentoring of research fellows and junior faculty and to support training for the PI in genetics and neuroimaging techniques that will enhance clinical trials of nicotine dependence treatment interventions.

Tobacco Studies

Concurrent PET D2/D3 Receptor Imaging and fMRI Cue Reactivity in Smokers [Details]

Principal Investigator(s): Evins, 2091—2015
Study Reference: NIDA R21 DA031925

This study aims to determine whether smokers have increased expression of dopamine D2/D3 receptors than do non-smokers and whether there is an association between D2/D3 expression, as measured with positron emission tomography, and functional MRI reactivity to smoking cues, which, when increased, predicts relapse to smoking after initial abstinence.

Center to Accelerate Translation of Interventions to Decrease Premature Mortality in SMI [Details]

Principal Investigator(s): Daumit, 2018—2022
Study Reference: NIH/NIMH 1 P50 MH115842-01

The Center will develop and test innovative strategies for scaling-up effective interventions to address cardiovascular risk behaviors (unhealthy diet, physical inactivity, tobacco smoking) and risk factors (obesity, hypertension, diabetes and dyslipidemia) among consumers with SMI.

Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illnesses [Details]

Principal Investigator(s): A. Eden Evins, M.D., M.P.H., 2016—2021
Study Reference: PCORI 1504-30472

The aim of this study is to study the effectiveness of two practical approaches to improve the health of people with mental illness in the community. The project will test whether tailored education to primary care doctors alone or combined with community health workers will help those with mental illness quit smoking. More than 1,100 patients at 50 Boston area community health clinics will be involved. Bay Cove Human Services and Vinfen, two of the largest mental health service providers in the Commonwealth, will lead the clinical component of this study.

A Positive Psychology Smartphone Intervention for Young Adult Intermittent Smokers [Details]

Principal Investigator(s): Hoeppner, B, 2014—2015
Study Reference: ECOR # 2014A051686

The goal of this project is to develop a positive psychology smoking cessation smartphone app for young adults who are intermittent smokers.

Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients (FITNESS) [Details]

Principal Investigator(s): Evins, 2014—2015
Study Reference: NIMH R01 MH104560

This project proposes to conduct an open-label, four-site randomized controlled trial of a fixed-dose, combination of drugs versus usual treatment for the prevention of cardiovascular disease among patients receiving second-generation antipsychotic drugs for severe mental illness. The trial assesses the effectiveness of an initial treatment strategy using moderate doses of HMG-Co A reductase inhibitors and angiotensin receptor blockers which have proven efficacy and safety. We will test this treatment strategy within mental health clinics.

Mentoring in Patient-Oriented Addiction Research [Details]

Principal Investigator(s): Kelly, 2014—2019
Study Reference: National Institute of Alcohol Abuse and Alcoholism/K24AA022136-01

This grant is designed to develop specific content expertise in treatment and recovery policy, and the design, implementation, and evaluation of treatment and recovery support service combinations. This grant also allows for mentoring junior investigators in patient-orientated addiction research (POAR).

Trial of Integrated Smoking Cessation, Exercise and Weight Management in SMI [Details]

Principal Investigator(s): Daumit, Evins, 2014—2019
Study Reference: NIH/NIMH 5R01MH104553-04

This clinical trial tested the hypothesis that an 18-month CVD risk reduction program consisting of smoking cessation treatment and weight reduction and exercise would improve cardiovascular health in persons with serious mental illness.

Smoking Cessation in College Student Smokers [Details]

Principal Investigator(s): Hoeppner, B.
Study Reference: K01 DA027097

This ecological momentary assessment (EMA) study (n=100) captured changes in smoking outcome expectancies and other thoughts and feeling in college student smokers in their natural environment as they were undergoing a quit attempt.

Impact of Electronic Cigarette Initiation on Motivation to Quit, Exposure to Smoke and Exposure to Nicotine [Details]

Principal Investigator(s): Hoeppner, B.
Study Reference: K01 DA027097

This pilot study tested the feasibility of daily smokers providing real-life real-time reports of their thoughts, feelings and smoking behavior while they were initiating and trying out electronic cigarette use.

Ecological Momentary Assessment in Young Adult Intermittent Smokers [Details]

Principal Investigator(s): Hoeppner, B., 2013—2013
Study Reference: K01 DA027097

This pilot study tested the feasibility of non-daily young adult smokers using ecological momentary assessment while they were undergoing a quit attempt.

Reduced Nicotine Cigarettes in Smokers with Mood and Anxiety Disorders [Details]

Principal Investigator(s): Evins, 2013—2018
Study Reference: P50 DA 036107-01

The aim of this study is to assess the effect of switching to gradually reduced nicotine content cigarettes on product use patterns and biomarkers of exposure, on psychiatric and nicotine withdrawal symptoms and on self-perception of tobacco dependence, self-report of intention to quit smoking, and actual smoking cessation attempts in smokers with mood and/or anxiety disorders.

Landing pages:
http://boston.craigslist.org/gbs/vol/5275723869.html
http://boston.craigslist.org/bmw/vol/5265708831.html

More information at ClinicalTrials.gov.

Proof-of-Concept Trial of an Alpha-7 Nicotinic Agonist for Nicotine Dependence (Supplement) [Details]

Principal Investigator(s): Evins/Favaal, 2012—2015
Study Reference: Envivo Pharmaceuticals

This investigator-initiated study provides study medication and additional funding to supplement NIDA R01 DA030992 to evaluate the efficacy of a novel alpha-7 nicotinic cholinergic receptor partial agonist for reducing cognitive deficits associated with nicotine withdrawal and assess its efficacy as a smoking cessation treatment.

Assessment of Varenicline and Bupropion Hydrochloride for Smoking Cessation [Details]

Principal Investigator(s): Evins, 2011—2015
Study Reference: PFIZER. A3051123

A 24-week multinational, phase 4, randomized, double blind, active and placebo-controlled, multicenter study evaluating the neuropsychiatric safety and efficacy of 12 weeks varenicline tartrate 1 mg BID and bupropion hydrochloride 150 mg BID for smoking cessation in subjects with and without a history of psychiatric disorders. The objective this study is to characterize the neuropsychiatric safety profiles of varenicline and bupropion for subjects with and without a diagnosis of psychiatric disorder.

More information at ClinicalTrials.gov.

Follow up to Study A3051123: Cardiac Assessments after Smoking Cessation Treatments [Details]

Principal Investigator(s): Evins, 2011—2015
Study Reference: PFIZER. A3051123

This study is a non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.

More information at ClinicalTrials.gov.

Proof-of-Concept Trial of an Alpha-7 Nicotinic Agonist for Nicotine Dependence [Details]

Principal Investigator(s): Evins/Favaal, 2011—2015
Study Reference: NIDA R01 DA030992

The aim of this project is to conduct a Phase IIb, randomized clinical trial to evaluate the effect of an alpha-7 nicotinic cholinergic receptor partial agonist on cognitive deficits associated with nicotine withdrawal and assess its efficacy as a smoking cessation treatment when used as monotherapy or in conjunction with nicotine patch in a 2x2 design clinical trial.

More information at ClinicalTrials.gov.

Enhancing Self-Control of Cigarette Craving with Real-Time fMRI [Details]

Principal Investigator(s): Evins, 2011—2014
Study Reference: NIDA R21 DA030523

The major aim of this project is to develop, optimize, and test real time functional magnetic resonance imaging neurofeedback from specified brain regions active during inhibitory control on learned control of brain activation while viewing smoking-related cues.

Recovery Research Institute (RRI) [Details]

Principal Investigator(s): Kelly, 2011—2019
Study Reference: Tower Foundation and private donors

Some of the RRI projects include building and maintaining a website in order to provide a credible source of information to debunk addiction and recovery myths, and provide free access to the latest recovery research information; building and evaluating recovery support programs in the community; building and evaluating recovery support programs in educational settings such as high schools and colleges; understanding the impact of community mutual-help organizations; addiction treatment system program evaluation.

Smoking Cessation and Cessation Maintenance in Smokers with and without Severe Mental Illness (SMI) During Sustained Pharmacotherapy with Varenicline [Details]

Principal Investigator(s): Evins, 2010—2015
Study Reference: NIDA K24 DA030443

This study is using a combined data set consisting of the data collected at MGH by Dr. Evins from a study population of smokers with SMI and a study with a comparable study design conducted at Pfizer in a population of smokers without SMI. The aim is to test the hypotheses that smokers without SMI will achieve a higher proportion of continuous tobacco abstinence during the maintenance of smoking cessation phase (i.e., in the 12 weeks post randomization, study weeks 12-24) than smokers with SMI, but this diagnosis effect will be normalized (i.e., will not be apparent) in the active pharmacotherapy (i.e., varenicline) group; smokers without SMI will have a longer mean time to relapse than smokers with SMI, and this difference will be greatest under placebo conditions and less pronounced in participants receiving active pharmacotherapy (varenicline) and that smokers without SMI will achieve a higher proportion of biochemically validated 7-day point prevalence tobacco abstinence during active, open-label treatment with varenicline than smokers with SMI, even after adjusting for baseline differences in age, gender, severity of nicotine dependence, cigarettes smoked per day, age of onset of daily smoking.

Extended Duration Varenicline for prevention of Relapse to Smoking in Patients with Schizophrenia [Details]

Principal Investigator(s): Evins, 2010—2014
Study Reference: Investigator Initiated Grant Pfizer Inc.

This investigator-initiated study provides study medication and additional funding to supplement NIDA R01 DA021245 ‘Smoking Cessation and Smoking Relapse Prevention in Patients with Schizophrenia’ to evaluate safety and efficacy of varenicline in smokers with schizophrenia.

Cognitive Remediation with D-cycloserine to Improve Smoking Cessation Outcomes [Details]

Principal Investigator(s): Evins, 2010—2013
Study Reference: NIDA R21 DA030808

The major aim of this randomized clinical trial was to evaluate the effect of addition of the putative cognitive-enhancing agent, D-cycloserine, to cue exposure therapy on reactivity to smoking-related cues and relapse in recently abstinent smokers.

Effect of Mindfulness Training on Impulsivity in Smokers [Details]

Principal Investigator(s): Evins, 2010—2013
Study Reference: NIDA R03DA030899

Evaluation of feasibility and efficacy of Mindfulness Training (MT) in comparison to Cognitive Behavioral Therapy (CBT) for smoking cessation.

Mentoring in Addiction Treatment Research [Details]

Principal Investigator(s): Evins, 2010—2015
Study Reference: NIDA K24 DA030443

The major aim of this career award is to provide support for mentoring of research fellows and junior faculty and to support training for the PI in genetics and neuroimaging techniques that will enhance clinical trials of nicotine dependence treatment interventions.

Memory Reconsolidation Blockade as a Novel Intervention for Nicotine Dependence [Details]

Principal Investigator(s): Evins, 2008—2010
Study Reference: NIDA R21 DA025186

The major aim of this randomized clinical trial was to test the hypothesis that a single dose of propranolol given prior to smoking-related cue exposure would decrease psychophysiological responses to smoking cues one week later through a process of memory reconsolidation blockade.

Received Cutting Edge Basic Research Award.

Smoking Cessation and Smoking Relapse Prevention in Patients with Schizophrenia [Details]

Principal Investigator(s): Evins, 2007—2013
Study Reference: NIDA R01 DA021245

The major aim of this randomized treatment discontinuation trial was to test the hypothesis that smokers with schizophrenia require extended duration pharmacotherapy to prevent relapse to smoking.

Glycine Transport Inhibition for Nicotine Dependence in Schizophrenia [Details]

Principal Investigator(s): Evins, 2006—2012
Study Reference: NIDA R01 DA022276

The major aim of this randomized clinical trial was to test the hypothesis that a single dose of propranolol given prior to smoking-related cue exposure would decrease psychophysiological responses to smoking cues one week later through a process of memory reconsolidation blockade.

Cooperative Drug Discovery for the Treatment of Nicotine Dependence [Details]

Principal Investigator(s): Evins, Fava, 2004—2013
Study Reference: NIDA U01 DA019378

The major aim of this study was to test two novel Phase II compounds for efficacy for treatment of nicotine dependence and to test a predictive battery of putative biomarkers for response to treatment.

Alcohol and Mixed Drug Use Studies

Supplemental grant for Development and Testing of Adolescent Twelve-Step Facilitation [Details]

Principal Investigator(s): Kelly, 2014—2014
Study Reference: National Institute of Alcohol Abuse and Alcoholism/R01AA019664-01A1S1

This study is the first to develop and test in a randomized experimental design the efficacy of an integrated 12-step facilitation intervention tailored for young people.

Characterization and Evaluation of Addiction Recovery Community Centers [Details]

Principal Investigator(s): Kelly, 2014—2016
Study Reference: National Institute of Alcohol Abuse and Alcoholism /R21AA022693-01A1

This study will characterize and evaluate the public health and addiction recovery utility of addiction recovery community centers in the United States. This experimental/developmental investigation will characterize RCCs in New England and New York, and survey RCC clients to examine abstinence and remission rates and the accrual of recovery capital and enhanced quality of life.

Mentoring in Patient-Oriented Addiction Research [Details]

Principal Investigator(s): Kelly, 2014—2019
Study Reference: National Institute of Alcohol Abuse and Alcoholism/K24AA022136-01

This grant is designed to develop specific content expertise in treatment and recovery policy, and the design, implementation, and evaluation of treatment and recovery support service combinations. This grant also allows for mentoring junior investigators in patient-orientated addiction research (POAR).

Decision-Making and Drug Use [Details]

Principal Investigator(s): Gilman, 2013—2016
Study Reference: NIH/NIDA 1K01DA034093-01A1

The aim of the study is to design novel behavioral tasks that will allow us to separate and empirically measure factors that predict social influence. We would like to design new tasks based on classic psychological studies that will allows us to model social influence, to observe differences between non-dependent young adults aged 18-25 who use either alcohol (ALC) or marijuana (MJ), and age-matched controls (CON), in order to investigate differences in susceptibility to social influence and in neural activation of regions associated with social influence as a function of early drug use.

Internet ad for the Decision-Making and Drug Use Study

Development and Testing of Adolescent Twelve-Step Facilitation [Details]

Principal Investigator(s): Kelly, 2011—2016
Study Reference: National Institute of Alcohol Abuse and Alcoholism/R01AA019664-01A1

This study is the first to develop and test in a randomized experimental design the efficacy of an integrated 12-step facilitation intervention tailored for young people.

More information at ClinicalTrials.gov.

Enhanced Treatment for Binge Drinking Depressed College Students [Details]

Principal Investigator(s): Pedrelli, 2011—2016
Study Reference: K23 AA020064

This is the first randomized controlled study on the effectiveness of a treatment combining Cognitive Behavioral Therapy and Brief Motivational Intervention (CBT+BMI) for college students with depressive symptoms who binge drink. Given the severe consequences associated with binge drinking and depressive symptoms in college students identifying an effective treatment for this population has critical public health significance. The Treatment for Excessive Alcohol Use and Depression in Students (TREADS) study lasts approximately 12 weeks. As part of the study participants complete a baseline visits and then are randomized, by chance, like the flip of a coin, to one of two therapy programs. Both courses include eight therapy visits and teach coping skills for depressive symptoms. However, in one therapy program participants receive a personalized feedback about their alcohol use, while in the other program they may or may not talk about alcohol consumption depending on the students’ preference. Both courses teach the same coping skills for depressive symptoms but include different levels of focus on alcohol. Participants complete one follow-up assessment visit at the end of the therapy program and one four weeks later. The three assessment visits are reimbursed.

Landing page links:
https://www.massgeneral.org/psychiatry/forms/collegestress2.aspx
https://www.massgeneral.org/psychiatry/forms/collegestress.aspx

Recovery Research Institute (RRI) [Details]

Principal Investigator(s): Kelly, 2011—2019
Study Reference: Tower Foundation and private donors

Some of the RRI projects include building and maintaining a website in order to provide a credible source of information to debunk addiction and recovery myths, and provide free access to the latest recovery research information; building and evaluating recovery support programs in the community; building and evaluating recovery support programs in educational settings such as high schools and colleges; understanding the impact of community mutual-help organizations; addiction treatment system program evaluation.

Mechanisms and Moderators of Behavior Change among Youth Treated for Alcohol Use Disorders [Details]

Principal Investigator(s): Kelly, 2010—2013
Study Reference: National Institute of Alcohol Abuse and Alcoholism/R21AA018185-01

This study examined the treatment and continuing care responses of young adults (18-25yrs) with specific examination of the mechanisms through which relapse and recovery occurs, for whom, and what points.

Mentoring in Addiction Treatment Research [Details]

Principal Investigator(s): Evins, 2010—2015
Study Reference: NIDA K24 DA030443

The major aim of this career award is to provide support for mentoring of research fellows and junior faculty and to support training for the PI in genetics and neuroimaging techniques that will enhance clinical trials of nicotine dependence treatment interventions.

Adolescent Treatment and 12-Step Mutual-help Participation [Details]

Principal Investigator(s): Kelly, 2006—2010
Study Reference: National Institute of Alcohol Abuse and Alcoholism/R01AA015526-01

This study examined the process, proximal and distal treatment outcomes of this highly prevalent, but under-studied, treatment model among youth.

Depression and Other Mental Health Conditions

Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illnesses [Details]

Principal Investigator(s): A. Eden Evins, M.D., M.P.H., 2016—2021
Study Reference: PCORI 1504-30472

The aim of this study is to study the effectiveness of two practical approaches to improve the health of people with mental illness in the community. The project will test whether tailored education to primary care doctors alone or combined with community health workers will help those with mental illness quit smoking. More than 1,100 patients at 50 Boston area community health clinics will be involved. Bay Cove Human Services and Vinfen, two of the largest mental health service providers in the Commonwealth, will lead the clinical component of this study.

Integrated Behavioral Diabetes Management for Individuals with Serious Mental Illness [Details]

Principal Investigator(s): Cieslak, Evins, 2016—2018
Study Reference: Executive Committee on Community Health (ECOCH) Community Health/Health Equity Grant

The goal of this project was to improve health outcomes for people with serious mental illness (SMI) and diabetes, a highly prevalent comorbidity that results in high levels of healthcare utilization and poor medical outcomes, including significant premature mortality. We developed a 16-week tailored behavioral and educational group intervention for individuals with schizophrenia and diabetes, utilizing the concept of ‘reverse integrated care,’ bringing medical intervention into the community mental health setting. Core features of this intervention included motivational interviewing, basic education, and problem solving.

Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorder [Details]

Principal Investigator(s): Kelly, 2014—2016
Study Reference: National Institute of Mental Health/R21MH101271-01

This study will characterize Depression and Bipolar Support Alliance (DBSA) participants and their participation in the organization; and, obtain preliminary estimates of the organizations’ purported clinical and recovery utility.

More information at ClinicalTrials.gov.

Neurobehavioral Predictors of Weight-Loss Surgery Outcomes [Details]

Principal Investigator(s): Evins, 2013—2015
Study Reference: Global Foundation for Eating Disorders

The major aim of this project is to begin to characterize neurobehavioral similarities and differences in certain phenotypes of obesity and addictive substance use disorders.

Decision-Making and Drug Use [Details]

Principal Investigator(s): Gilman, 2013—2016
Study Reference: NIH/NIDA 1K01DA034093-01A1

The aim of the study is to design novel behavioral tasks that will allow us to separate and empirically measure factors that predict social influence. We would like to design new tasks based on classic psychological studies that will allows us to model social influence, to observe differences between non-dependent young adults aged 18-25 who use either alcohol (ALC) or marijuana (MJ), and age-matched controls (CON), in order to investigate differences in susceptibility to social influence and in neural activation of regions associated with social influence as a function of early drug use.

Internet ad for the Decision-Making and Drug Use Study

Optimizing Real-time fMRI for Neurotherapeutic Discovery and Development [Details]

Principal Investigator(s): Evins, 2013—2014
Study Reference: Radcliff Institute for Advanced Study Conference Grant

This grant provided funding to hold an Exploratory Seminar at the Radcliffe Institute for Advanced Study to bring 18 scientists together from across the US for a two-day meeting with the aim of advancing development of real-time fMRI as a neurotherapeutic tool with applications to addictive disorders, obsessive-compulsive disorder, major depressive disorder, post-traumatic stress disorder, and optimized learning.

Reduced Nicotine Cigarettes in Smokers with Mood and Anxiety Disorders [Details]

Principal Investigator(s): Evins, 2013—2018
Study Reference: P50 DA 036107-01

The aim of this study is to assess the effect of switching to gradually reduced nicotine content cigarettes on product use patterns and biomarkers of exposure, on psychiatric and nicotine withdrawal symptoms and on self-perception of tobacco dependence, self-report of intention to quit smoking, and actual smoking cessation attempts in smokers with mood and/or anxiety disorders.

Landing pages:
http://boston.craigslist.org/gbs/vol/5275723869.html
http://boston.craigslist.org/bmw/vol/5265708831.html

More information at ClinicalTrials.gov.

Enhanced Treatment for Binge Drinking Depressed College Students [Details]

Principal Investigator(s): Pedrelli, 2011—2016
Study Reference: K23 AA020064

This is the first randomized controlled study on the effectiveness of a treatment combining Cognitive Behavioral Therapy and Brief Motivational Intervention (CBT+BMI) for college students with depressive symptoms who binge drink. Given the severe consequences associated with binge drinking and depressive symptoms in college students identifying an effective treatment for this population has critical public health significance. The Treatment for Excessive Alcohol Use and Depression in Students (TREADS) study lasts approximately 12 weeks. As part of the study participants complete a baseline visits and then are randomized, by chance, like the flip of a coin, to one of two therapy programs. Both courses include eight therapy visits and teach coping skills for depressive symptoms. However, in one therapy program participants receive a personalized feedback about their alcohol use, while in the other program they may or may not talk about alcohol consumption depending on the students’ preference. Both courses teach the same coping skills for depressive symptoms but include different levels of focus on alcohol. Participants complete one follow-up assessment visit at the end of the therapy program and one four weeks later. The three assessment visits are reimbursed.

Landing page links:
https://www.massgeneral.org/psychiatry/forms/collegestress2.aspx
https://www.massgeneral.org/psychiatry/forms/collegestress.aspx

Comprehensive CVD Risk Reduction Trial in Persons with Serious Mental Illness (Triumph Trial)
Smoking Cessation and Cessation Maintenance in Smokers with and without Severe Mental Illness (SMI) During Sustained Pharmacotherapy with Varenicline [Details]

Principal Investigator(s): Evins, 2010—2015
Study Reference: NIDA K24 DA030443

This study is using a combined data set consisting of the data collected at MGH by Dr. Evins from a study population of smokers with SMI and a study with a comparable study design conducted at Pfizer in a population of smokers without SMI. The aim is to test the hypotheses that smokers without SMI will achieve a higher proportion of continuous tobacco abstinence during the maintenance of smoking cessation phase (i.e., in the 12 weeks post randomization, study weeks 12-24) than smokers with SMI, but this diagnosis effect will be normalized (i.e., will not be apparent) in the active pharmacotherapy (i.e., varenicline) group; smokers without SMI will have a longer mean time to relapse than smokers with SMI, and this difference will be greatest under placebo conditions and less pronounced in participants receiving active pharmacotherapy (varenicline) and that smokers without SMI will achieve a higher proportion of biochemically validated 7-day point prevalence tobacco abstinence during active, open-label treatment with varenicline than smokers with SMI, even after adjusting for baseline differences in age, gender, severity of nicotine dependence, cigarettes smoked per day, age of onset of daily smoking.

Extended Duration Varenicline for prevention of Relapse to Smoking in Patients with Schizophrenia [Details]

Principal Investigator(s): Evins, 2010—2014
Study Reference: Investigator Initiated Grant Pfizer Inc.

This investigator-initiated study provides study medication and additional funding to supplement NIDA R01 DA021245 ‘Smoking Cessation and Smoking Relapse Prevention in Patients with Schizophrenia’ to evaluate safety and efficacy of varenicline in smokers with schizophrenia.

Smoking Cessation and Smoking Relapse Prevention in Patients with Schizophrenia [Details]

Principal Investigator(s): Evins, 2007—2013
Study Reference: NIDA R01 DA021245

The major aim of this randomized treatment discontinuation trial was to test the hypothesis that smokers with schizophrenia require extended duration pharmacotherapy to prevent relapse to smoking.

Glycine Transport Inhibition for Nicotine Dependence in Schizophrenia [Details]

Principal Investigator(s): Evins, 2006—2012
Study Reference: NIDA R01 DA022276

The major aim of this randomized clinical trial was to test the hypothesis that a single dose of propranolol given prior to smoking-related cue exposure would decrease psychophysiological responses to smoking cues one week later through a process of memory reconsolidation blockade.