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Pilot study of tolerability and safety of opioid receptor antagonists as novel therapies for chronic pain among persons living with HIV with past year heavy drinking: a randomized controlled trial

Title
Pilot study of tolerability and safety of opioid receptor antagonists as novel therapies for chronic pain among persons living with HIV with past year heavy drinking: a randomized controlled trial
Publication Type
Journal Article
Research Type
Human
Reported as
Clinical Trial
Date
March 07, 2021
Authors
Sally Bendiks, Debbie M. Cheng, Elena Blokhina, Marina Vetrova, Elena Verbitskaya, Natalia Gnatienko, Kendall Bryant, Evgeny Krupitsky, Jeffrey H. Samet & Judith I. Tsui
Institution
Boston University, First Pavlov State Medical University, NIAAA, V.M. Bekhterev Nat Med Res Ctr; University of Washington
Link
Abstract

Pain is common and associated with substance use among persons with HIV (PWH), yet limited management strategies exist. We assessed the feasibility, tolerability, and safety of low-dose naltrexone and standard dose nalmefene to treat chronic pain among PWH with past-year heavy alcohol use in a randomized, double-blinded, 2-arm study (planned enrollment 8 per arm). Participants were recruited in St. Petersburg, Russia between May and October 2018 and randomized to receive either nalmefene (16 mg) or low-dose naltrexone (4.5 mg) for 8 weeks. The primary outcome was tolerability of medication at eight weeks. Study visits included assessments of pain interference and severity, as well as cold-pressor testing. All participants in the nalmefene arm (N = 3) discontinued the study medication early due to side effects; nalmefene was subsequently deemed intolerable and this arm was terminated. The mean tolerability score at 8-weeks in the low-dose naltrexone arm was 90.7 (SD 22.44), median was 100 (IQR 95- 100), and median cold pain tolerance was approximately 10 s higher at the end of the 8 weeks. Low-dose naltrexone was well-tolerated, but nalmefene was not, in this sample. Further research is warranted to explore low-dose naltrexone’s potential efficacy as a non-addictive treatment for pain in this population.

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