At a glance
ClinicalIndex Comparison Record- ✓Exceed NIAAA weekly or daily drinking guidelines
- ✓Receive care at the 865 clinic
- ✓Fluent in English
- ✓Able to read English at eighth grade level or higher with no significant cognitive impairment
- ✕Meet DSM-5 criteria for drug dependence other than marijuana or nicotine
- ✕On probation or parole
- ✕Serious psychiatric illness (psychotic disorder, bipolar disorder, severe major depression) requiring pharmacologic treatment or currently treated with psychotropic medication
- ✕Organic mood or mental disorders, or substantial suicide or violence risk
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
In Brief
A Phase 2 clinical trial evaluating Motivation Enhancement Therapy, Modified Behavioral Self-Control Therapy, and 3 other interventions for Alcohol-Related Disorders and 4 related conditions. Completed, enrolled 27 participants across 1 site.
Detailed Summary
The purpose of this research study is to develop and test a care model to treat excessive drinking and alcohol use disorders in the primary care setting. The goal of this research study is to increase the identification and treatment of problem drinking in the primary care setting. Individuals will be asked to participate in this study because routine screening and assessment conducted at your primary care clinic indicates that you have recently exceeded healthy drinking limits as outlined by the National Institutes of Alcohol and Alcoholism.
Study Details
Timeline
Interventions
Motivation Enhancement Therapy (MET) similarly allows for goal choice in treatment, and has been shown to be effective in treating a broad spectrum of drinking problems in both abstinent and non-abstinent goal conditions. The unique goals of MET (enhancing intrinsic motivation for change and facilitating development of a self-generated change plan).
Motivational Interviewing was developed to increase self-efficacy and motivation for drinking, and Cognitive Behavioral Therapy allows for individuals to develop strategies for drinking reduction. Both are evidence-based interventions that have been combined in previous studies for drinking reduction in problem drinkers.
Participants, who choose medication treatment, will be offered naltrexone (50 mg per day), which is an FDA-Approved medication for alcohol use disorder. According to the package insert for NTX, the medication has been associated with liver toxicity at very high doses (up to 300 mg/day); however, a number of clinical trials and published studies suggest there are few serious adverse effects, including minimal hepatotoxicity, associated with daily dose of 50 mg of naltrexone. Its most common side effects in opioid-free individuals are nausea, vomiting, anxiety, headache, abdominal discomfort, difficulty sleeping, fatigue, irritability, and decreased appetite. A rare serious adverse effect may include minimal liver toxicity, but is more likely to occur at very high doses (300 mg/day).
Brief Advice (BA) consists of a 20-minute session delivered by a study therapist, adhering to the NIAAA's Clinician Guide to Problem Drinkers. It includes personalized, normative feedback based on NIAAA drinking norms, goal selection, instructions on self-monitoring, discussion of drink reduction strategies, and distribution of the NIAAA bibliotherapy guide.
Participants who present with complex drinking concerns will be referred to specialty substance use disorder treatment. This treatment will be provided in a separate treatment facility that focuses on substance use disorders and will potentially provide a combination of medication management and individual/group behavioral treatment for substance use disorders.