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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of heavy drinking days by medication group (timeline follow back calendar).

Secondary outcome measures

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,149 Total Patients Enrolled

26 Trials studying Alcoholism

3,590 Patients Enrolled for Alcoholism

Alkermes, Inc.Industry Sponsor

114 Previous Clinical Trials

26,828 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

Media Library

Placebo intramuscular injection Clinical Trial Eligibility Overview. Trial Name: NCT05028062 — Phase 4

Alcoholism Research Study Groups: XR-NTX 380 mg, intramuscular injection, Inactive placebo intramuscular injection

Alcoholism 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has XR-NTX 380 mg, intramuscular injection been trialed in any other scientific studies?

"Presently, there are 46 ongoing clinical trials studying the effects of XR-NTX 380 mg, intramuscular injection with 12 at Phase 3. The bulk of research is being conducted in New york City, however a total of 161 sites have launched studies related to this medication."

Answered by AI

Do I qualify to partake in this clinical experiment?

"This clinical trial is seeking around 60 volunteers with the diagnosis of alcoholism, aged between 18 and 65."

Answered by AI

What therapeutic effects is XR-NTX 380 mg, intramuscular injection used to treat?

"XR-NTX 380 mg, intramuscular injection is often utilised to treat chronic weight management. Additionally, this medication can be beneficial for increasing physical activity levels, alleviating pain and promoting healthy dietary choices."

Answered by AI

What is the scope of participation in this research endeavor?

"Affirmative. Clinicaltrials.gov data indicates that the recruitment for this medical trial, which was first released on March 7th 2022, is ongoing and seeking 60 patients from a single site."

Answered by AI

Are there any adverse consequences to intramuscular infusion of XR-NTX 380 mg?

"There is ample clinical evidence supporting XR-NTX 380 mg, intramuscular injection's safety profile, thus it achieved a score of 3."

Answered by AI

Does this trial accept participants who are younger than 70 years of age?

"All potential participants for this study must fall between the age bracket of 18 and 65 years old."

Answered by AI

Is access to this trial open at the present moment?

"The clinical research trial is actively accepting patients, as indicated on the clinicaltrials.gov website. The study was first announced on March 7th 2022 and underwent its last update on June 6th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Naltrexone in AUD Reward Drinkers

2022. "Naltrexone in AUD Reward Drinkers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05028062.

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