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The Center for Addiction Medicine is currently running clinical trials focusing on alcohol, nicotine and cocaine dependence. Learn more about the Center for Addiction Medicine’s active trials.
West End Clinic
Under Dr. Eden Evins’ leadership for the past 6 years, the MGH CAM has become a leading research group, currently funded by 8 major grants from NIDA and NIAAA. It has grown to include four full time faculty, two part time faculty, 5 post-doctoral fellows, one program coordinator and 10 research coordinators.
Currently, the Center is engaged in over 10 ongoing patient oriented addiction trials studying pharmacological and behavioral treatments of alcohol, other drug, and nicotine dependence, with a total subject enrollment each year of over 300 patients.
The studies listed below are currently enrolling participants. You can also search clinical trials in other areas online.
Comprehensive CVD Risk Reduction Trial in Persons with Serious Mental Illness (Triumph Trial), NHLBI R01 HL112299 (2013 – 2017)The major aim of this trial is to test feasibility and effectiveness of an 18-month, comprehensive cardiovascular health intervention with a heart health specialist in a psychiatric rehabilitation setting in people with serious mental illness and cardiovascular risk factors with the major aim of reducing cardiovascular risk in this vulnerable population.
Reduced Nicotine Cigarettes in Smokers with Mood and Anxiety Disorders, P50 DA 036107-01 (2013 – 2018)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.
Trial of Integrated Smoking Cessation, Exercise, and Weight Management in SMI (Achieve Trial), NIMH R01 MH104553 (2013 – 2018)The aim of this randomized trial embedded in community mental health programs is to test a practical smoking-cessation program integrating weight management counseling, exercise and text messaging support. If successful, the intervention will be a model program that could be disseminated widely and should reduce health disparities in cardiovascular disease risk in persons with serious mental illness.
Fixed dose intervention trial of New England enhancing survival in SMI patients (FITNESS), NIMH R01 MH104560 (2014 – 2018)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.
Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illnesses, PCORI 1504-30472 (2016 – 2020)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.
Smoking cessation and cessation maintenance in smokers with and without severe mental illness (SMI) during sustained pharmacotherapy with varenicline, 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 following hypotheses:
Decision-Making and Drug Use, NIH/NIDA 1K01DA034093-01A1
Using Functional Magnetic Resonance Imaging to Characterize Cigarette Smoking in Neurocognitive Domains, NIH K24DA030443-04The purpose of this study is to characterize the structural and functional brain circuitry of smokers in order to gain a better understanding of the neuroscience underlying nicotine addiction. Specifically, we use neuroimaging to characterize smokers in 3 domains; cue reactivity, sustained attention, and inhibitory control; as well as asses resting brain function.
Using Imaging to Assess Effects of THC on Brain Activity, NIDA 1K01DA034093The 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.
Web-based Survey of Individuals Interested in Using Medical Marijuana, NIH/NIDA 1K01DA034093-01A1The 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, 5K01DA034093-03The 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.
Recovery Research Initiative, funded by the Tower Foundation and private donorsThe Recovery Research Initiative is housed within the Department of Psychiatry at MGH under the auspices of the CAM. Under the leadership of Dr. John F. Kelly, the RRI will begin to push the agenda for addiction recovery forward by conducting high quality, recovery relevant research, and disseminating and implementing results for the benefit of our communities and broader society. The RRI will become a center for training promising scientists for careers in addiction and recovery research.
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.
Learn more about active studies being conducted by the Center for Addiction Medicine.
Glycine Transport Inhibition for Nicotine Dependence in Schizophrenia (Evins PI) NIDA R01DA022276 (2006 – 2012)Individuals with schizophrenia smoke almost three times more than the general population and are less likely to quit smoking with available therapies. Tobacco- derived nicotine has been shown to improve negative symptoms, improve impaired cognitive function, and normalize reward responsivity in individuals with schizophrenia, which is why it is harder for them to quit. Sarcosine has been shown to have the same effects on the brain as tobacco-derived nicotine on individuals with schizophrenia. This study aimed to determine whether sarcosine has the potential to be an effective therapy for nicotine dependence for individuals with schizophrenia.
Mind and Life Institute. Effect of Mindfulness Training on Impulsivity in Smokers, NIDA R21 DA030808 (2010 – 2012)
Evaluation of feasibility and efficacy of Mindfulness Training (MT) in comparison to Cognitive Behavioral Therapy (CBT) for smoking cessation.
Smoking Cessation and Relapse Prevention in Subjects with Schizophrenia (Evins PI) NIDA R01DA021245 (2007 – 2012)Individuals with schizophrenia have higher smoking relapse rates than smokers in the general population, perhaps because schizophrenia patients have reduced nicotinic responsiveness that is not expected to return to normal after smoking cessation. Continuation of a nicotinic agonist may reduce rates of relapse to smoking. It is likely that longer duration of pharmacotherapy is needed to prevent relapse to smoking in patients with schizophrenia. To assess this possibility, this study will give patients 12 months of pharmacotherapy to help them quit smoking for the long-term. This study is currently enrolling 260 smokers with schizophrenia.
Cognitive Remediation with D-cycloserine to Improve Smoking Cessation Outcomes (Evins PI) NIDA R21DA030808 (2010 – 2013)After people quit smoking, they find that there are many environmental triggers that make them crave smoking again. For this reason, many quitters eventually relapse so that fewer than 20% of people who try to quit smoking are actually successful. The drug d-cycloserine (DCS) has been shown to help eliminate previously learned behaviors that are cued by different environmental triggers. This study aims to determine whether by reducing the craving to smoke with DCS combined with cue exposure therapy (CET), individuals are less likely to relapse after they have quit smoking. This study is currently enrolling 60 healthy male and female smokers aged 18-65 who have smoked an average of at least 15 cigarettes per day during the past year.
Enhancing Self-Control of Cigarette Craving with Real-Time fMRI, NIDA R21DA030523 (2011 – 2013)Although there are many treatments available to help quit smoking, up to 90% of people who quit still relapse within the first year. This mainly occurs when individuals are exposed to environmental triggers that make them crave smoking again. When this happens, the brain’s activity increases and this can be measured with functional magnetic resonance imaging (fMRI). This study aims to understand the brain mechanisms that cause individuals to relapse after smoking cessation, and potentially create a new form a therapy that will reduce the urge to smoke after they quit. This study is currently seeking 160 healthy male and female smokers aged 18-55 who have smoked an average of at least 10 cigarettes per day during the past year.
Extended Duration Varenicline for Prevention of Relapse to Smoking in Patients with Schizophrenia, Investigator Initiated Grant Pfizer Inc. (2010 – 2014)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.
Optimizing Real-Time fMRI for Neurotherapeutic Discovery and Development, Radcliff Institute for Advanced Study Conference Grant (2013 – 2014)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.
Enhancing Self-Control of Cigarette Craving with Real-Time fMRI, NIDA R21 DA030523 (2013 – 2014)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.
A 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 (study A3051123), Pfizer (2011 – 2015)This is a 24-week multicenter, multinational, randomized, double-blind placebo and NRT controlled trial designed to assess the safety and efficacy of varenicline 1 mg BID and bupropion hydrochloride 150 mg BID for smoking cessation. 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.
A phase 4, non-treatment follow-up for cardiac assessments following use of smoking cessation treatments in subjects with and without a history of psychiatric disorders, Pfizer (2011 – 2015)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.
Mentoring in Addiction Treatment Research, NIDA K24 DA030443 (2010 – 2015)
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.
Concurrent PET D2/D3 Receptor Imaging and fMRI Cue Reactivity in Smokers, NIDA R21 DA031925 (2012 – 2015)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.
Longitudinal Study of Neurocognitive Effects of Cannabis Use, Private Funding (2014 – 2015)
Neurobehavioral Predictors of Weight Loss Surgery Outcomes, Global Foundation for Eating Disorders (2012 – 2015)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.
Proof-of-Concept Trial of an Alpha-7 Nicotinic Agonist for Nicotine Dependence, NIDA R01DA030992 (2011 – 2016)When people quit smoking, a major symptom of nicotine withdrawal is cognitive impairment. This type of impairment can make individuals more likely to start smoking again in order to get rid of that side effect. The Alpha 7 acetylcholine receptor agonist, EVP 6124, has been shown to improve mental performance, such as ability to pay attention and focus for extended periods of time. This study aims to determine whether by improving cognitive performance with EVP 6124, individuals who are trying to quit smoking are more likely to sustain abstinence. This study is currently enrolling 450 healthy male and female smokers aged 18-65 who have smoked an average of at least 15 cigarettes per day during the past year.
Cooperative Drug Discovery for the Treatment of Nicotine Dependence, NIDA U01 DA019378 (2004 – 2013)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.
Proof-of-Concept Trial of an Alpha-7 Nicotinic Agonist for Nicotine Dependence, NIDAR01 DA030992(2011 – 2015)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.
Helping Others and Long-term Outcomes among Youth with Substance Use Disorders, Templeton Foundation (2009 - 2012)This multi-site prospective study examines how facilitating altruism (e.g., helping behaviors) among substance-involved adolescents and young adults may facilitate further adaptive addiction recovery-related changes in substance use and psychosocial functioning.
Mechanisms and Moderators of Behavior Change among Youth Treated for Alcohol use Disorders, NIAAA R21AA018185 (2010 – 2013)This study examines the treatment and continuing care responses of young adults (18-25 years) with specific examination of the mechanisms through which relapse and recovery occurs, for whom, and what points.
Development and Testing of Adolescent Twelve-Step Facilitation, NIAAA R01AA019664 (2011 – 2014)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. In the first phase of the study, we are developing and revising a preliminary manual for the two sessions individually-delivered Motivational Enhancement Therapy component and subsequent 8 session group-delivered CBT component which will integrate Twelve-step Facilitation (TSF). Three groups of 8-12 adolescents each will complete the preliminary integrated iTSF protocol. In the second phase of the study, we will compare iTSF to standard treatment (MET/CBT) in a randomized experimental design for adolescent substance use disorder with 60 adolescents. As a result, we will examine potential mechanisms that may underlie the efficacy of iTSF in improving alcohol and other drug use outcomes. We will test group differences on potential mechanisms of change (e.g., AA/NA attendance and involvement) and whether these variables are associated with substance use outcomes.
Development of Real-Time fMRI as a Novel Adjunctive Behavioral Treatment for Addictions (Stoeckel PI) Zinberg Fellowship (2010 - 2011)Up to 90% of people who quit smoking relapse within the first year, even with the best treatment available. Thus, it is necessary to develop a better understanding of the neurobiological basis of addiction, and of relapse in particular, in order to help people maintain abstinence. This project tested real-time fMRI used with emotion regulation strategies, as a way to understand and potentially modulate the neurobiology of addiction and of relapse in particular.
Correlates of Nicotine Enhancement of Reward Responsiveness in Schizophrenia (Stoeckel PI) Brain and Behavior Research Foundation (2011 – 2013)There are an increasing number of known links between the use of nicotine and the neurobiology of schizophrenia. It has been theorized that negative symptoms, such as lack of drive to pursue goals or inability to experience pleasure, may be improved via nicotine intake by normalizing brain systems that are involved in reward and motivation, which is why so many individuals with schizophrenia struggle with nicotine abstinence. The ultimate goal of this study is to better understand reward and inhibitory control deficits in schizophrenia and to establish a therapeutic target for negative symptoms of schizophrenia.
Dynamic Processes of Smoking Cessation (Hoeppner PI) NIDA 5K01DA027097-02 (2010 – 2015)Approximately 20% of college students smoke cigarettes, which is significantly lower than in 2005, but still a major public health concern. This study examines smoking outcome expectancies (an individual’s anticipation of the effects of a future experience) in college student smokers attempting to quit. The study is currently seeking 120 college students who would like to quit smoking.
Effects of Mindfulness Training on Impulsivity and Inhibitory Control in Smokers (Schuman-Olivier PI) NIDA R03DA030899 (2010 – 2012) It has been found that mindfulness meditation benefits people with substance use disorders through cognitive mechanisms, such as decreased thought suppression, decreased stress reactivity, and decreased motor impulsiveness. However, no widely accepted behavioral measures of impulsivity or inhibitory control have been used to measure the effect of mindfulness practice in smokers. This project aims to evaluate the relationship between mindfulness and behavioral measures of impulsivity and inhibitory control in smoking cessation and early abstinence.
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