XR-NTX 380 mg, intramuscular injection for Alcoholism

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Alcoholism+1 More
Medical Management - Behavioral
Eligibility
18+
All Sexes
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Study Summary

This trial will test whether an injection of naltrexone reduces heavy drinking in people who are 'reward drinkers'.

Eligible Conditions
  • Alcoholism
  • Alcohol Use Disorder

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Alcoholism

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 8 weeks

8 weeks
Frequency of drinking days, and drinks/drinking day by medication group (timeline follow back calendar).
Frequency of heavy drinking days by medication group (timeline follow back calendar).

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Alcoholism

Trial Design

2 Treatment Groups

XR-NTX 380 mg, intramuscular injection
1 of 2
Inactive placebo intramuscular injection
1 of 2
Active Control
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: XR-NTX 380 mg, intramuscular injection · Has Placebo Group · Phase 4

Inactive placebo intramuscular injectionPlaceboComparator Group · 2 Interventions: Medical Management, Placebo intramuscular injection · Intervention Types: Behavioral, Drug
XR-NTX 380 mg, intramuscular injectionActiveComparator Group · 2 Interventions: Medical Management, XR-NTX 380 mg, intramuscular injection · Intervention Types: Behavioral, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,816 Previous Clinical Trials
41,115,033 Total Patients Enrolled
23 Trials studying Alcoholism
3,416 Patients Enrolled for Alcoholism
Alkermes, Inc.Industry Sponsor
112 Previous Clinical Trials
24,117 Total Patients Enrolled
14 Trials studying Alcoholism
3,137 Patients Enrolled for Alcoholism
Henry R Kranzler, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
344 Total Patients Enrolled
2 Trials studying Alcoholism
343 Patients Enrolled for Alcoholism

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: October 6th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.