Testing the Reward-Drinker Hypothesis of Naltrexone Using an

Recruiting

18 years - 65 years

All

Phase 4

60 participants needed

1 Location

Brief description of study

This study is being conducted to compare the effects of a medication (extended-release naltrexone or XR-NTX) or placebo (an inactive substance) together with brief counseling on reducing or stopping drinking.

XR-NTX is approved by the U.S. Food and Drug Administration (FDA) for treating alcohol dependence. Its use is experimental in the treatment of alcohol dependence in people whose primary reason for drinking alcohol is to obtain its rewarding effects (“reward drinkers”).

Participants will be compensated/reimbursed for their time and effort. Participants may be compensated up to $345 if they are eligible to participate and complete all study visits.

Detailed description of study

This is a 7 visit study to occur over 12 weeks. This includes an initial screening visit, an 8-week treatment phase (during which time you will receive 2 injections at 4-week intervals of XR-NTX or a placebo), and a follow-up visit 4 weeks after the treatment phase. We expect to enroll a total of 60 people in the study. A summary of the visits is below:

1) Screening visit to determine your eligibility (~3 hours)

2) 1^st Study Drug Visit at week 1 (~1.5 hours)

3) 3 bi-weekly visits at weeks 2, 4, and 6 (~1 hour each)

4) Endpoint visit at week 8 (~ 1 hour)

5) Follow-up visit, 4 weeks after endpoint visit (~1 hour)

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: alcohol,alcohol use disorder,addictions
Age: 18 years - 65 years
Gender: All

Updated on 04 Aug 2024. Study ID: 849558

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Testing the Reward-Drinker Hypothesis of Naltrexone Using an Extended-Release Formulation

Brief description of study

Detailed description of study

Eligibility of study

Find a site

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