NCT03278886

St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pain is a common co-morbidity for HIV-infected patients. Prevalence studies suggest that, on average, half of all HIV-infected persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-infected persons, which may in turn be a barrier to treatment/control of HIV and contribute to spread of HIV. Thus there is an urgent need to address pain among persons with HIV. Opioid receptor antagonists such as naltrexone and nalmefene, which are licensed for treatment of alcohol use disorders, show promise as being effective and safe treatments for chronic pain among persons with HIV. This study will pilot test novel pharmacotherapies (opioid receptor antagonists) to improve chronic pain among HIV-infected heavy drinkers. The specific aims of the research is to assess the feasibility, tolerability and safety of using opioid receptor antagonists (low-dose naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol use and chronic pain.

Conditions

• HIV Infection
• Alcohol Use
• Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-07-03
• Primary completion: 2018-12-19
• Completion: 2018-12-19
• First posted: 2017-09-12
• Last updated: 2020-08-24
• Results posted: 2020-08-03

Locations

1 site across 1 country: Russia