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Opioid Antagonist

Vivitrol (Extended Release Naltrexone) for Alcoholism

Phase 4
Waitlist Available
Led By Maria Raven, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will assess the feasibility of a multimodal treatment for alcohol use disorders in the emergency department. The treatment includes extended release naltrexone and case management.

Eligible Conditions
  • Alcoholism
  • Substance Abuse

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Daily Total Alcohol Consumption From Baseline at 3 Months
Change in Total Alcohol Consumption at 12 Months
Participants Retained in Study at 3 Months
+1 more
Secondary outcome measures
Change in Quality of Life Score at 3 Months
Other outcome measures
Change in Alcohol Related Life Consequences (Short Inventory of Problems Scale, Version 2R: SIP-2R)
Change in ED Utilization
Change in WHO Drinking Risk Level
+4 more

Side effects data

From 2019 Phase 2 trial • 29 Patients • NCT03008590
7%
Dizziness
3%
Infections, minor viral or bacterial
3%
Ankle injury
3%
Fatigue
3%
Lip and tongue swelling
3%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
During Placebo Treatment
During Naltrexone Treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: Multimodal InterventionExperimental Treatment1 Intervention
The intervention is multimodal and consists of: Intramuscular injections of 380mg extended-release Naltrexone, given once monthly for 3 months. Case Management services

Find a Location

Who is running the clinical trial?

The CARESTAR FoundationUNKNOWN
University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,292 Total Patients Enrolled
19 Trials studying Alcoholism
3,044 Patients Enrolled for Alcoholism
Maria Raven, MDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder
2020. "Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04094584.
~38 spots leftby Apr 2025
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