Testing the Reward-Drinker Hypothesis of Naltrexone Using an Extended-Release Formulation
University of Pennsylvania
Summary
This study is a phase IV, two-arm, randomized, double-blind, placebo-controlled study to assess whether individuals identified as primarily reward drinkers are significantly more likely to reduce heavy drinking if they receive XR-NTX than a matching placebo injection. Study subjects will receive monthly injections of long-acting injectable naltrexone 380 mg (4 mL) or matching placebo. All subjects will also receive 4 sessions of Medical Management (MM). Post-treatment follow-up visits will be conducted at 4 weeks after the scheduled completion of treatment.
Description
Study eligibility is determined at an initial screening visit, which can be completed in a single day or divided over multiple days. Portions of the screening may occur by telephone or video conference. Participants are asked not to drink before this and at all study visits. At all study visits, study staff will check breath alcohol level using a breathalyzer. If the breath alcohol level is greater than 0.02% (which can result from a single standard drink), participants may not be able to complete the visit. Screening Visit: The screening visit will determine whether the study is a good fit f…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18-65 years old * Willing to provide signed, informed consent and commit to completing the study procedures * Able to read at an 8th grade or higher level * Current DSM-5 diagnosis of AUD * Reports consuming 24+ standard drinks (men) or 18+ standard drinks (women) weekly on average over the month prior to consent * Expresses a desire to reduce or stop drinking and a willingness to receive two injections of study medication over 8 weeks of treatment. * Either a reward drinker \[i.e., an individual with a score of 19 or greater on the reward subscale and less than or e…
Interventions
- DrugXR-NTX 380 mg, intramuscular injection
Two doses of XR-NTX 380 mg, intramuscular injection.
- BehavioralMedical Management
All subjects will receive 8 weeks of medical management (Pettinati et al. 2004) will support subjects' efforts to reduce or stop their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the subject's drinking, and make recommendations to follow until the next visit. Men will be advised to consume no more than 3 drinks 4 times per week; women will be advised to consume no more than 2 drinks 4 times per week.
- DrugPlacebo intramuscular injection
Two doses of XR-NTX 380 mg, intramuscular injection.
Location
- University of Pennsylvania Center for Studies of AddictionPhiladelphia, Pennsylvania