Status:
COMPLETED
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Chronic Pain
Alcohol Use, Unspecified
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 pai...
Detailed Description
Pain is a common co-morbidity for HIV-positive patients.Prevalence studies suggest that, on average, half of all HIV-positive persons suffer pain. Chronic pain can lead to heavy alcohol use among HIV-...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04052139
Start Date
January 25 2021
End Date
December 15 2021
Last Update
November 10 2022
Active Locations (1)
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1
First St. Petersburg Pavlov State Medical University
Saint Petersburg, Russia