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NCT05028062 · ClinicalTrials.gov registry record · Phase 4
Naltrexone in AUD Reward Drinkers
A Phase 4 study of Alcohol Use Disorder and Alcoholism, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05028062: Recruiting Phase 4 study of Alcohol Use Disorder and Alcoholism, sponsored by University of Pennsylvania.
NCT05028062 is a Phase 4 study of Alcohol Use Disorder and Alcoholism that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 60 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05028062, a Phase 4 study of Alcohol Use Disorder and Alcoholism, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The number of Heavy Drinking Days during 8 weeks of treatment in the Naltrexone and placebo groups.
Conditions Studied
Interventions
- DRUG XR-NTX 380 mg, intramuscular injection
- BEHAVIORAL Medical Management
- DRUG Placebo intramuscular injection
Study Locations (1)
Pennsylvania
- University of Pennsylvania Center for Studies of Addiction - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2028-07 |
| Phase | Phase 4 |
What NCT05028062 shows while recruiting
NCT05028062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which XR-NTX 380 mg, intramuscular injection is the first listed.
NCT05028062 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05028062 about?
NCT05028062 is a clinical study titled "Naltrexone in AUD Reward Drinkers". 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 mo...
What is the current status of trial NCT05028062?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2022-03-07. Estimated completion is 2028-07.
What conditions does trial NCT05028062 study?
This clinical trial studies the following conditions: Alcohol Use Disorder, Alcoholism.
What interventions are being tested in trial NCT05028062?
The interventions under investigation include: XR-NTX 380 mg, intramuscular injection (DRUG), Medical Management (BEHAVIORAL), Placebo intramuscular injection (DRUG).
Who is sponsoring clinical trial NCT05028062?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05028062 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05028062's enrollment target sits among peer trials
60 113th of 184 higher than 65 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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