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St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

NCT03278886 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-08-24

Study results available
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Summary

This study is a randomized controlled trial (RCT) to assess the feasibility, tolerability, and safety of using opioid receptor antagonists (naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol use and chronic pain.

Conditions

  • HIV Infection
  • Alcohol Use
  • Pain

Interventions

DRUG

Low dose naltrexone

4.5 mg of low dose naltrexone taken once daily for 8 weeks

DRUG

Nalmefene

18 mg of nalmefene taken once daily for 8 weeks

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey H. Samet, MD, MA, MPH · Boston University/Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2018-12-19
Completion
2018-12-19

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03278886 on ClinicalTrials.gov