St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a 3-arm pilot, randomized, double-blinded, placebo-controlled study of low-dose naltrexone and gabapentin versus placebo among HIV-positive persons with heavy alcohol use and chronic pain to provide estimates of their effects on 1) pain; 2) inflammation; and 3) measures of HIV control. Participants will be followed for 12 weeks. Assessments of study outcomes will be compared at week 8 (end of treatment phase).

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

Details

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

• Known uncontrolled psychiatric illness (such as active psychosis)

• Current suicidal ideation

• History of hypersensitivity to naltrexone, gabapentin, 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

• AST/ALT levels >5x normal

• CrCl< 60mL/min

• History of Reynaud's disease

• Planned surgeries in the next 3 months

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

• Taking naltrexone in the past 30 days

• Taking gabapentin in the past 30 days

• Taking pregabalin in the past 30 days

• Diagnosis of chronic obstructive pulmonary disease (COPD)