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.

Marijuana Smokers

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

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 Smokers

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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

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

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.

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.

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.

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

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.

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.