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 fNIRS to Assess Effects of Substance Use on Brain Activity Principal Investigators: Jodi Gilman, Ph.D. Nearly 20% of adults in the U.S. struggle with substance use disorders (SUD), driving a growing public health crisis. This trial will enroll 80 participants, including 40 adults with a substance use disorder (SUD) and 40 healthy individuals. Using functional near-infrared spectroscopy (fNIRS), participants will undergo brain scans to measure brain activity in the prefrontal cortex, a region critical for decision-making and impulse control. The study aims to determine how substance use impacts brain function, and explore whether increased brain activity can be a potential biomarker for addiction. This study will advance our understanding of the neurobiology of addiction, which could ultimately lead to improved treatments and interventions for those struggling with substance use. This study is now closed for recruitment. Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients with Cannabis Use Disorder Principal Investigator(s): Jodi Gilman, Ph.D. The rate of Cannabis Use Disorder (CUD) is steadily increasing in the United States as widespread commercialization of the substance continues. Despite many clinical trials of off-label medications, there are no FDA-approved medication treatments for CUD. The goal of this study is to observe the impact of suvorexant on brain activity of people who frequently use cannabis. Suvorexant is an FDA-approved medication to treat insomnia. In this project, we will use MR imaging before and after two weeks of suvorexant administration to investigate changes in insula activation to cannabis-related cues. This pilot-study will allow investigators to collect vital data on a promising new pharmacotherapeutic treatment method for CUD. This study is now closed for recruitment. Evaluation of Cannabidiol for Reduction of Brain Neuroinflammation Principal Investigator(s): Jodi Gilman, Ph.D., Marco Loggia, Ph.D. Treatment for chronic pain is largely ineffective, likely due to a lack of viable targets. Cannabinoids, particularly cannabidiol (CBD), are among the therapeutics attracting attention for their potential pain applications. In this project, we will use PET/MR imaging to image glial activation in patients with chronic low back pain (cLBP), and investigate whether CBD, compared to placebo, reduces pain- and depression-related neuroinflammation in cLBP. This will be the first study to test potential effects of CBD on neuroinflammation and striatal physiology in pain patients, and could help reconcile the conflicting findings regarding the efficacy of cannabinoids in pain conditions. This study is now closed for recruitment. Dopamine and Cannabis Consumption: A PET/MRI Imaging Study Principal Investigator(s): Hsiao-Ying Wey, Ph.D., Jodi Gilman, Ph.D. A pilot study that aims to observe the effect of cannabis use on the dopamine system. In this single-blind cross-over trial, approximately 30 participants with and without a family history of psychosis who regularly use cannabis will complete PET/MRI scans following the administration of dronabinol (synthetic THC) or placebo before and after a 6-week period of cannabis abstinence. This study is now closed for recruitment. Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid Dose in Patients with Chronic Non-Cancer Pain Principal Investigator(s): Jodi Gilman, Ph.D., A. Eden Evins, M.D., MPH Controversy exists over the risk to benefit ratio of medical marijuana for adults with chronic non-cancer pain (CNCP) on chronic opioid therapy (COT). The primary goal of this proposal is to assess whether medical marijuana, when added to a behavioral prescription opioid taper support program, improves pain and reduces opioid dose in adults on COT for CNCP more so than the behavioral intervention alone. This information is critical to better inform patients and clinicians about the extent to which medical marijuana use may be beneficial or harmful to this patient population. This study is now closed for recruitment. Characterizing Proximal Risk for Depressive Symptoms and Suicidal Ideation with Acute Cannabis Use and Withdrawal Among Adolescents Using Ecological Momentary Assessment Principal Investigator: Randi Schuster, Ph.D., 2021—2022 Study Reference: ECOR The goal of this project is to collect critical pilot data on proximal relationships between acute cannabis use and withdrawal on depressive symptoms and suicidal ideation using ecological momentary assessment among depressed adolescents. Cognition and Adolescent Health Principal Investigator: Randi Schuster, Ph.D., 2015—2022 Study Reference: NIH/NIDA 1K23DA042946-02 The purpose of this study is to determine whether there is cognitive dysfunction in adolescent cannabis use that persists in the short term (four days) after use but resolves with extended abstinence (30 days) compared to cannabis users who do not quit and non-using controls, as well as estimate the rate of cognitive improvement with cannabis abstinence as a function of time since last use and concentration of detectable cannabis metabolites in urine. This study will also examine whether genetic risk for ADHD and other psychiatric co-morbidities alters the rate of cognitive recovery with cannabis abstinence. Integrated Smoking Cessation Treatment for Smokers with Serious Mental Illnesses Principal Investigator: A. Eden Evins, M.D., MPH, 2016—2021 Study Reference: PCORI 1504-30472 The aim of this study is to assess the effectiveness of two practical approaches to improving the health of people with mental illness in the community. The project will test whether tailored education to primary care doctors alone or combined with community health workers will help those with mental illness quit smoking. More than 1,100 patients in 50 Boston area community health clinics will be involved. Bay Cove Human Services and Vinfen, two of the largest mental health service providers in the Commonwealth, will lead the clinical component of this study. Positive Psychology Smoking Cessation Smartphone App for Nondaily Smokers Principal Investigator(s): Bettina Hoeppner, Ph.D., Susanne Hoeppner, Ph.D., Lourah Kelly, Ph.D., John F. Kelly, Ph.D. 2016—2021 Study Reference: 130323-RSG-17-021-01-CPPB The goal of this project is to develop a smartphone app to support smoking cessation in nondaily smokers using a positive psychology approach. A three-phase development process is proposed, using (1) in-depth feedback from n = 30 on our already developed Version 1.0, (2) a nation-wide pilot test of Version 2.0 (n = 90), and (3) a proof-of-concept randomized controlled trial (n = 226). Pilot Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults with Substance Use Disorder Study Principal Investigator(s): Kate Bentley, Ph.D. 2018—2020 Training Grant Principal Investigator(s): A. Eden Evins, M.D., MPH & Nancy Rigotti, M.D. Study Reference: NIH/NIDA 5K12DA043490 (Career Development Program) The purpose of this pilot study is to examine the acceptability, feasibility, and preliminary efficacy of adding a transdiagnostic, emotion-focused, cognitive-behavioral group intervention to treatment as usual within a comprehensive outpatient addiction program for young adults (ages 18 to 26) with substance use disorder and co-occurring anxiety or depressive symptoms, suicidal ideation, or nonsuicidal self-injury. Participants (n = 50) are randomly assigned to receive the experimental group intervention plus treatment as usual or treatment as usual alone, and substance use (via timeline followback), anxiety and depressive symptoms, and emotion regulation indices are assessed at baseline and four and eight weeks after randomization. The Impact of Medicaid Plans on Access to and Quality of SUD Treatment Principal Investigator: Margarita Alegria, Ph.D. 2018—2021 Study Reference: NIH/NIDA 1R01DA044526-01A1 This project makes use of random assignment methods to study the effects of the structure of state Medicaid programs on access, patterns of care and outcomes of substance use disorder (SUD) care. It conducts stratified analysis by race/ethnicity, gender, and rurality to identify which programs and plans have better outcomes and if there are service disparities. It uses qualitative methods to help interpret results and suggest changes to policy and practice. Vignette Study Principal Investigator: John F. Kelly, Ph.D. Privately Funded This privately funded study looks at terminology and stigma, and how word choice may affect attitudes and perceptions. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VQW-765 in Patients with Performance Anxiety Principal Investigator(s): A. Eden Evins, M.D., MPH, 2021 Study Reference: Vanda Pharmaceutical The purpose of the study is to evaluate the effect of an investigational drug called VQW-765 on symptoms associated with performance anxiety and to assess the safety of VQW-765. Performance anxiety is a type of anxiety disorder characterized by excessive fear, discomfort, and self-consciousness in a variety of social situations related to performing in front of others such as public speaking. This intense and persistent fear in performance situations can result in significant impairment in almost all facets of daily life, including social activities, relationships, work, and studies. VQW-765 is an investigational drug. It is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). In order to evaluate the effects of VQW-765 on social anxiety disorder symptoms and the safety of VQW-765, approximately 220 subjects will be enrolled nationwide and randomly assigned to one of two study drug groups: one group will receive VQW-765, and the other group will receive placebo.
