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Clinical Trials: Addiction/Substance Abuse
IRB No. 06-586-2 (Dr. Jonathan Covault, PI): Howard University Study of College Student Daily Life Experiences and the Interaction of Genetic Variation
Alcohol consumption among college students is considered a widespread problem. This study is designed to evaluate the day-to-day associations among alcohol use, school-related behaviors, stressful events and mood states over the course of one month period. Results will be examined in relation to natural genetic variations measured by genotyping of salivary DNA samples from participants. Up to 330 undergraduate college students at Howard University, ages 18-26 years old will be examined.
IRB No. 07-131-1 (Dr. Jonathan Covault, PI): Behavioral Gene Bank
The purpose of this registry/repository is to collect diagnostic data (psychiatric and medical diagnoses) and tissue specimens from subjects and/or family members in order to build a Behavioral Gene Bank (BGB). The registry/repository aims to study; subjects with known or suspected genetic or medical syndromes; families with high concentrations of psychiatric illness; and subjects with dysmorphic features or other clinical characteristics suggestive of a genetic or chromosomal disorder. Relatives of individuals with these features and healthy controls will also participate. Subjects will be invited to participate in further behavioral studies in the future.
IRB No. 089-89-1 (Dr. Victor Hesselbrock, PI): Participating Center for Genetics for Alcoholism (Collaborative Study) COGA
Study description not available
IRB No. 1337-85-1 (Dr. Victor Hesselbrock, PI): (1) Neuroelectric Correlates of Risk for Alcohol Dependence (2) Deviance Proneness and the Risk for Alcohol Dependence
Study description not available
IRB No. 12-174-3 (Dr. Mark Litt, PI): Individualized Assessment and Treatment for Marijuana Dependence: Treatment Mechanisms
Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana dependence is not fully effective. The most effective treatments to date have employed motivational enhancement (MET) plus cognitive-behavioral coping skills treatment (CB) and contingency management (CM) for abstinence. In the current study we are exploring the idea that more tailored teaching of coping skills may result in improved outcomes for marijuana-dependence than those seen thus far. The Individualized Assessment and Treatment Program (IATP) for marijuana dependent patients will employ experience sampling (ES) to determine the strengths and weaknesses of each patient in drug-use situations so that treatment can be tailored accordingly. Participants will be 275 men and women meeting criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of 4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two weeks prior to treatment, for a weekly period during treatment, for another week after treatment has ended, and for two weekly periods at months 8 and 14. The data collected will shed light on the ways in which patients in treatment use coping skills in real-time contexts. Finally, the use of repeated ES periods will allow us to determine how treatment impacts thoughts, feelings and behaviors, and how these in turn affect outcome in the long and short term. We expect that all treatments will prove effective for reducing marijuana use.
IRB No. 13-056-2 (Dr. Jonathan Covault, PI): Dutasteride Treatment for the Reduction of Heavy Drinking
This study will use a 12-week randomized, placebo controlled clinical design to examine the safety and efficacy of dutasteride treatment (1mg daily) combined with medical management to help reduce or stop drinking among a sample of 160 men with hazardous levels of alcohol use. Other aims are: to examine the durability of effects of dutasteride treatment on drinking and heavy drinking during a six-month post-treatment follow-up; to examine whether treatment response is moderated by a common genetic variation, H5Q, in the neuroactive steroid biosynthetic enzyme 3a-hydroxysteroid dehydrogenase gene AKR1C3 that has been associated with alcohol dependence; and to examine the potential effects of dutasteride on the relations among daily mood and daily events on drinking and heavy drinking, and the potential effects of dutasteride on daily reports of alcohol subjective effects to identify potential intermediate effects of dutasteride on treatment outcomes.
IRB No. 14-174-2 (Dr. Jane Ungemack, PI): Substance Abuse Family Evaluation, Recovery and Screening (SAFERS) Project
CT's Substance Abuse Family Evaluation, Recovery and Screening (SAFERS) project will develop a comprehensive family recovery support service, RCM-E, by adding components to an existing recovery support model, Recovery Case Management (RCM), for substance abusing caregivers who risk removal of their children and termination of their parental rights. SAFERS will establish comprehensive screening for caregivers (substance use, HIV risk, mental health, parenting, trauma and family violence) and trauma screening for infants and young children 0-6 years of age (bridging a gap in screening for this age group), joint service planning and concrete supports to enhance linkages to existing evidence-based services for these families. The evaluation will assess the degree to which the SAFERS program meets its objectives to: 1) implement a comprehensive and coordinated network of behavioral health and support services that promote the well-being of substance-involved families; 2) develop and implement culturally and gender appropriate family services; 3) increase screening and referral for substance abuse and related problems; 4) improve parents' access, engagement and retention in substance abuse treatment; 5) increase access to evidence-based trauma-informed interventions that promote positive child development, parenting skills and healthy parent-child relationships; 6) provide cross-agency training to increase awareness and understanding of substance use disorder and its consequences for adults and children, child development, trauma and recovery for all SAFERS partners and other key stakeholders; 7) promote inter-agency data sharing; and 8) show improvements in rates of out-of-home placements and repeat maltreatment.
IRB No. 09-156H-1 (Dr. Nancy Petry, PI): Reward Center
Study description not available
IRB No. 14-185C-3 (Dr. Yifrah Kaminer, PI): Treatment for Teens and Young Adults with Marijuana and/or Alcohol Abuse and Depression
The purpose of this study is to test an innovative approach to treat the combination of marijuana and/or alcohol abuse and depression. All individuals will receive standard outpatient talk therapy for marijuana and/or alcohol use that lasts for 12 weeks. After 4 weeks of treatment, each person’s depression will be re-evaluated. If the depression is much improved, he/she will continue in the treatment marijuana and/or alcohol use. For those who are still depressed after 4 weeks, we will randomly assign one-half to an additional new investigational depression talk therapy. The other half of the individuals will be assigned to additional standard depression treatment outside of the study. The study team will work with the individual and family to access a community provider. Each individual will be assessed several times throughout the 12- week treatment. This program is for teens and young adults between the ages of 13-21 who abuse marijuana and/or alcohol and struggle with depression. Participation in this no cost program is completely voluntary. Teen/Young Adult may be compensated up to $175 in gift cards and parents up to $140 in gift cards for full participation in the program. Participants are asked to provide urine samples at various times during the treatment program. Treatment sessions and assessments will take place at UConn Health and transportation may be provided within the study catchment area, if needed, to and from the treatment site.
IRB No. 16-148-3 (Dr. Jonathan Covault, PI): Zonisamide treatment of Alcohol Use Disorder: An Evaluation of Efficacy and Mechanism of Action
Alcohol use disorders (AUDs) are highly prevalent (lifetime prevalence estimated to be >30% in the U.S. general population, and >40% in military veterans) and have large detrimental impacts on patients, their families and society. The number of FDA-approved medication treatments for alcoholism is limited in number (naltrexone, acamprosate, disulfiram) and have only modest effects. Anticonvulsant (anti-epileptic) medications have shown evidence of efficacy in treating alcoholism. Zonisamide (ZNS) is an anticonvulsant and a promising potential treatment for AUDs. Zonisamide reduces drinking, craving for alcohol, and anxiety in subjects with AUDs. We (Arias, Feinn, Oncken, Covault, and Kranzler. 2010) completed a randomized, placebo-controlled pilot trial of zonisamide for treating alcohol dependence, which showed reductions in heavy drinking, overall drinking, and alcohol craving with the medication. Zonisamide was very well tolerated in the pilot study. Recently, another small placebo-controlled trial of zonisamide showed advantages of the medication over placebo in reducing drinking. However, no definitive study of ZNS treatment for alcoholism has been performed. In this study we will test if the medication zonisamide can reduce harmful drinking patterns, and try to determine whether medication response can be predicted by a few key factors such as genotype, age of onset of alcoholism (early vs. late), or stress-reactivity. This study includes an innovative pharmacogenomics secondary component that examines whether the total number of risk alleles for a panel of previously identified alcohol use and stress response risk alleles is associated with treatment response. The study is funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) via a grant to Dr. Arias at Yale University and seeks to recruit 160 subjects across 2 clinical sites (West Haven VA Alcohol Research Center and UConn Health Center). Understanding how ZNS works, and for whom it works best, will advance pharmacologic treatment for alcohol use disorders and bring us closer to personalized treatment.
IRB No. 16-211-3 (Dr. Mark Litt, PI): Individualized Assessment and Treatment Program for Alcoholism: Treatment and Mechanisms
This is a study to test different outpatient treatments for alcohol problems. Interested persons can reach us by phone to be scheduled for an interview. Those eligible for the study will be asked to engage in a cellphone-based recording procedure prior to start of treatment to allow us to get a sense of their drinking problems. For some patients, this information will be used by a therapist for tailoring an individualized cognitive-behavioral treatment for that person. This individualized assessment and treatment program (IATP) will be compared to a more conventional packaged cognitive-behavioral treatment (PCBT), and to a Case Management condition (CaseM). Each treatment will be delivered individually, and will last 12 weeks, with another 18 months of follow-ups scheduled at 3-month intervals. Additional cellphone monitoring periods will be scheduled during treatment and afterwards, during the follow-up period. All of the treatments delivered here have shown excellent results for people with alcohol problems. We will recruit 207 men and women meeting criteria for alcohol use disorder. Eligible persons will be randomly assigned to one of the three treatments. By comparing IATP with CaseM and PCBT we will be able to control for the general effects of study participation (i.e., “common factors”), the effects of being in a treatment study and receiving manualized treatment, general skills training (psychoeducation), and therapist presence. Thus the study will help us find out what are active aspects of treatment for alcohol use disorder.