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.
Using Imaging to Assess Effects of THC on Brain Activity [
Details]
Principal Investigator(s): Gilman, Evins, MaravicStudy 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.
Effect of Medical Marijuana on Neurocognition and Escalation of Use [
Details]
Principal Investigator(s): Jodi Gilman , 2016—2020Study 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.
Cognition and Adolescent Health [
Details]
Principal Investigator(s): Schuster, Gilman, Evins, 2015—2020Study 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—2019Study 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—2016Study 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.

Using Imaging to Assess Effects of THC on Brain Activity [
Details]
Principal Investigator(s): Gilman, 2013—2017Study 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.
Concurrent PET D2/D3 Receptor Imaging and fMRI Cue Reactivity in Smokers [
Details]
Principal Investigator(s): Evins, 2091—2015Study 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.
Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illnesses [
Details]
Principal Investigator(s): A. Eden Evins, M.D., M.P.H., 2016—2021Study 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.
Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients (FITNESS) [
Details]
Principal Investigator(s): Evins, 2014—2015Study 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—2019Study 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).
Reduced Nicotine Cigarettes in Smokers with Mood and Anxiety Disorders [
Details]
Principal Investigator(s): Evins, 2013—2018Study 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.
Assessment of Varenicline and Bupropion Hydrochloride for Smoking Cessation [
Details]
Principal Investigator(s): Evins, 2011—2015Study 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—2015Study 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—2015Study 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—2014Study 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.
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—2015Study 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.
Memory Reconsolidation Blockade as a Novel Intervention for Nicotine Dependence [
Details]
Principal Investigator(s): Evins, 2008—2010Study 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.
Characterization and Evaluation of Addiction Recovery Community Centers [
Details]
Principal Investigator(s): Kelly, 2014—2016Study 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—2019Study 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—2016Study 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.

Enhanced Treatment for Binge Drinking Depressed College Students [
Details]
Principal Investigator(s): Pedrelli, 2011—2016Study 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
Adolescent Treatment and 12-Step Mutual-help Participation [
Details]
Principal Investigator(s): Kelly, 2006—2010Study 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.
Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illnesses [
Details]
Principal Investigator(s): A. Eden Evins, M.D., M.P.H., 2016—2021Study 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.
Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorder [
Details]
Principal Investigator(s): Kelly, 2014—2016Study 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.
Decision-Making and Drug Use [
Details]
Principal Investigator(s): Gilman, 2013—2016Study 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.

Optimizing Real-time fMRI for Neurotherapeutic Discovery and Development [
Details]
Principal Investigator(s): Evins, 2013—2014Study 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—2018Study 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—2016Study 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
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—2015Study 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.