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.
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 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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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).
The goal of this project is to develop a positive psychology smoking cessation smartphone app for young adults who are intermittent smokers.
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.
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.
This pilot study tested the feasibility of non-daily young adult smokers using ecological momentary assessment while they were undergoing a quit attempt.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Evaluation of feasibility and efficacy of Mindfulness Training (MT) in comparison to Cognitive Behavioral Therapy (CBT) for smoking cessation.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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
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.
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.
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.
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.
This study examined the process, proximal and distal treatment outcomes of this highly prevalent, but under-studied, treatment model among youth.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.