
Human Laboratory Study of ASP8062 for Alcohol Use Disorder
Alcohol Use DisorderAlcohol Drinking1 moreThe primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary objectives include evaluation of ASP8062, 25 mg once a day, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

Mental Imagery Intervention for Alcohol Craving
Alcohol Use Disorder (AUD)A within-subjects crossover, randomised controlled trial conducted at a specialist NHS outpatient addictions clinics to determine if mental imagery (of future positive [recovery oriented] events) and a visuospatial task (playing Tetris) can help reduce cue-induced alcohol craving. Effects of both interventions will be compared.

A Dialectical Behavioral Therapy Digital Health Solution for Outpatients Seeking Support for Substance...
Alcohol Use DisorderSubstance Use DisordersThe purpose of this study is to compare the feasibility, acceptability, and efficacy of a dialectical behavior therapy skills training webapp known as "Pocket Skills" in outpatients and community members seeking treatment for substance use, across those who receive immediate versus delayed access to the intervention (e.g., a waitlist control condition).

Motivational Incentives for Alcohol Abstinence in American Indian and Native Alaskan Adults
Alcohol AbuseThis study examines the impact of a culturally tailored version of contingency management treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives. Participants will be recruited from addiction treatment agencies and throughout the community. Those who complete a 4 week induction period will be randomized to receive 12 weeks of contingency management or a non-contingent control condition. Individuals will then be followed for an additional 3-months to assess the long term efficacy of the treatment.

Rapid Determination Of The Clinical Utility Of Perampanel For The Treatment Of Alcohol Dependence...
AlcoholismThe purpose of this study is to determine whether perampanel alters the response to alcohol for heavy drinkers. It is hypothesized that perampanel will reduce the rewarding and reinforcing properties of alcohol in the laboratory setting.

Preventing Alcohol Withdrawal With Oral Baclofen
AlcoholismAlcohol WithdrawalThe purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. In several European studies, and in an earlier study at Essentia Health (NCT00597701), baclofen has been found to have a significant effect on the severity of symptoms of AWS.

Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence
Alcohol DependenceThe over-arching goal of the proposed project is to understand the impact of medication adherence upon engagement in behavioral treatment for alcohol use disorders. The proposed project is a pilot feasibility study of inpatient veterans with problem alcohol use at the William S. Middleton VA Hospital (Madison, WI). Participants will be randomized to one of two parallel study conditions: (1) an initial 50 mg oral dose of naltrexone prior to hospital discharge plus a 30-day prescription for oral naltrexone, or (2) a single 380 mg intramuscular injection of naltrexone administered prior to discharge and a second injection one month later. The central hypothesis is that hospital-administered injectable naltrexone, when compared to daily oral naltrexone taken at home, will reduce alcohol use in the days immediately following hospitalization. Injectable naltrexone has been efficacious vs. placebo in addition to behavioral treatment in several studies. However, it has yet to be examined in head-to-head comparison with oral naltrexone, or in the hospital setting as an intervention that might facilitate behavioral treatment follow up after discharge.

Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care
Alcohol DependenceThe proposed study is a pragmatic, randomized, open-label clinical trial of 24 weeks of XR-NTX vs. O-NTX using a COMBINE-adapted Medical Management primary care treatment model. 237 adults >18yo with alcohol dependence will be recruited from the community into treatment in public sector primary care settings. The primary outcome which powers this study is a dichotomous good clinical outcome defined by abstinence or moderate drinking, and as measured by the Timeline Follow-back and analyzed using an intention-to-treat approach among all randomized participants. Secondary outcomes include the incremental cost effectiveness of the two arms, differences between arms by continuous measures of alcohol intake (drinks/day, % days abstinent, time to first heavy drinking day, bio-markers), and the exploratory analysis of factors possibly associated with effectiveness, including gender, prior treatment abstinence, and mu opioid receptor (OPRM1) genotypes. Specific Aim 1: Treatment Effectiveness. To evaluate the effectiveness of extended-release naltrexone (XR-NTX) vs. oral naltrexone (O-NTX) in producing a primary good clinical outcome, defined as abstinence or moderate drinking (≤2 drinks/day, men; ≤1 drink/day,women; and ≤2 heavy drinking occasions/month), during the final 20 of 24 weeks of primary care-based Medical Management for alcohol dependence. Hypothesis: The rate of this good clinical outcome will be approximately twice as great among participants receiving XR-NTX compared with those receiving O-NTX. Specific Aim 2: Cost Effectiveness. To estimate the incremental cost effectiveness of XR-NTX vs. O-NTX,both in conjunction with primary care-based Medical Management. Hypothesis: XR-NTX treatment will be more cost effective than O-NTX. Specific Aim 3: Patient-Level Predictors of Effectiveness. To identify patient-level characteristics associated with effectiveness in both arms.

A Novel Compound for Alcoholism Treatment
AlcoholismAlcohol-Related Disorders3 moreBackground: - Hormones are naturally occurring chemicals in your body. Ghrelin is a hormone that is mainly produced by the stomach and stimulates appetite. Some studies suggest it may stimulate alcohol craving and use. Drugs have been developed that block ghrelin. Researchers want to know if people can tolerate a particular drug that blocks ghrelin. It will be given at two dose levels, combined with alcohol. Objective: - To determine if a drug that may decrease alcohol consumption when given along with alcohol is safe and tolerable. Eligibility: Healthy adults 21-65 years old who have 14 (women) to 21 (men) drinks a week. No one of childbearing potential can participate. Design: Participants will have 3 inpatient clinic visits; each will last 4 days. They will have physical exam and blood and urine tests. They will have breath tests for alcohol and smoking. They will answer health and mood questions. Researchers will measure their reaction to smelling alcohol and tasting a sweet drink. They will eat only the food provided by the clinic. They will keep a food diary 1 day before each stay. They will be randomly assigned to take the study drug or placebo 5 times each stay. On Day 3, they will drink alcohol after taking the drug. They will give many blood samples that day through a tube inserted in their skin. Smokers can take smoke breaks. Once, they will smoke a cigarette through a device. One week after the last stay, participants will have a follow-up visit to answer questions.

Development of Ibudilast for Alcohol Use Disorder
Alcohol Use DisordersThe objective of this proposal is to advance medication development for alcoholism by conducting a safety and initial efficacy study of ibudilast, a neuroimmune modulator and phosphodiesterase inhibitor, for alcohol use disorders.