St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

• Status: Completed
• Trial end date: 2018-12-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Nalmefene; Naltrexone

Criteria

Inclusion Criteria:

• 18 years or older

• HIV-positive

• Chronic pain (present ≥3 mo) of moderate to severe intensity

• Heavy drinking past year (Based on NIAAA criteria: > 14 standard drinks per week/ > 4 drinks in a day for men; > 7 drinks in the past week/ > 3 drinks in a day for women)

• If female, negative pregnancy test and willing to use adequate birth control

• Provision of contact information for 2 contacts to assist with follow-up

• Stable address within 100 kilometers of St. Petersburg

• Possession of a telephone (home or cell)

• Able and willing to comply with all study protocols and procedures

Exclusion Criteria:

• Not fluent in Russian

• Cognitive impairment resulting in inability to provide informed consent based on research assessor (RA) assessment

• Known active TB or current febrile illness

• Breastfeeding

• Uncontrolled psychiatric illness (such as active psychosis) (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the ED or hospital)

• History of hypersensitivity to naltrexone, nalmefene, or naloxone

• Current use (past week) of illicit or prescribed opiates as documented by either self-report or positive urine drug test

• Unwilling to abstain from opiates during the treatment period

• Current use of neuroleptics

• History of seizure disorder

• Known liver failure

• ALT/AST levels >5x normal

• History of Raynaud's Disease

• Planned surgeries in the next three months

• Enrolled in another HIV and/or substance use medication intervention study

• Taking naltrexone in the past 30 days

• Taking nalmefene in the past 30 days