St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
CompletedPhase 2NCT04052139
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems
- Conditions
- Chronic Pain
- Alcohol Use, Unspecified
- HIV Infections
- Interventions
- Drug: Low-dose naltrexone
- Drug: Gabapentin
- Drug: Placebo
- Sponsor
- Boston Medical Center
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Start date
- 2021-01-25
- Primary completion
- 2021-11-16
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Russia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04052139