๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-16

Naltrexone in AUD Reward Drinkers (NCT05028062)

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

๐ŸŸข Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: University of Pennsylvania

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of Pennsylvania Center for Studies of Addiction โ€” Philadelphia, Pennsylvania

Age range: 18 Years to 65 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • University of Pennsylvania Center for Studies of Addiction โ€” Philadelphia, Pennsylvania

๐Ÿ“ž Contact the Study Coordinator

Phone: (215) 746-1959

Email: timpond@pennmedicine.upenn.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—