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

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)

Additional Information

To participate in this study, you must be:

1) 18-65 years old

2) express a desire to reduce or stop drinking

3) able to complete all study visits and willing to receive 2 injections of study medication over 8 weeks of treatment.

Eligibility of study

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

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

Updated on 09 Mar 2024. Study ID: 849558

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).