Status:
COMPLETED
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
HIV Infection
Alcohol Use
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 p...
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...
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
- 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
Key Trial Info
Start Date :
July 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03278886
Start Date
July 3 2018
End Date
December 19 2018
Last Update
August 24 2020
Active Locations (1)
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1
First St. Petersburg Pavlov State Medical University
Saint Petersburg, Russia, 197022