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Naltrexone Injection for Alcoholism

Phase 4
Recruiting
Led By Henry R Kranzler, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 years old
Reports consuming 24+ standard drinks (men) or 18+ standard drinks (women) weekly on average over the month prior to consent
Must not have
Planned surgery within the timeframe of the study
Chronic or episodic painful conditions that could require opioid medications for pain control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

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

Who is the study for?
Adults aged 18-65 with Alcohol Use Disorder (AUD) who drink heavily and want to cut down or stop. They must be able to understand the study, have a stable address, and use reliable birth control if applicable. Excluded are those with certain mental health conditions, on conflicting medications, facing potential incarceration soon, having significant physical diseases or abnormal lab results, drug disorders other than alcohol/nicotine/cannabis, needing detoxification from alcohol or with a history of bad reactions to XR-NTX.
What is being tested?
The trial is testing whether long-acting injectable naltrexone (XR-NTX) helps people who primarily drink for pleasure more than a placebo in reducing heavy drinking. Participants will receive either XR-NTX or placebo injections monthly along with four sessions of Medical Management counseling over eight weeks.
What are the potential side effects?
Possible side effects include nausea, headache, dizziness, fatigue, injection site pain or reaction. There may also be risks related to liver function changes as well as rare but serious allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been drinking more than the recommended amount of alcohol weekly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for surgery during the study period.
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I have chronic pain that might need opioids for management.
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I have a history of seizures, not including childhood febrile seizures.
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I am currently taking medication for mental health, seizures, pain, blood thinning, or alcohol use disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of heavy drinking days by medication group (timeline follow back calendar).
Secondary study objectives
Frequency of drinking days, and drinks/drinking day by medication group (timeline follow back calendar).

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: XR-NTX 380 mg, intramuscular injectionActive Control2 Interventions
Subjects will receive an injection of XR-NTX 380 mg (4 mL) repeated once after 4 weeks.
Group II: Inactive placebo intramuscular injectionPlacebo Group2 Interventions
Subjects will receive a placebo injection repeated once after 4 weeks.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,561 Total Patients Enrolled
Alkermes, Inc.Industry Sponsor
115 Previous Clinical Trials
26,919 Total Patients Enrolled
Henry R Kranzler, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
344 Total Patients Enrolled

Media Library

Placebo intramuscular injection Clinical Trial Eligibility Overview. Trial Name: NCT05028062 — Phase 4
Alcohol Use Disorder Research Study Groups: XR-NTX 380 mg, intramuscular injection, Inactive placebo intramuscular injection
Alcohol Use Disorder Clinical Trial 2023: Placebo intramuscular injection Highlights & Side Effects. Trial Name: NCT05028062 — Phase 4
Placebo intramuscular injection 2023 Treatment Timeline for Medical Study. Trial Name: NCT05028062 — Phase 4
~15 spots leftby Nov 2025
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