Glenn-Milo Santos1, Phillip Coffin, Deirdre Santos, Shannon Huffaker, Tim Matheson, Jason Euren, Anna DeMartini, Christopher Rowe, Judith A Hahn, David Vlahov, Eric Vittinghoff, Steven L Batki. 1. *Center for Public Health Research Branch, San Francisco Department of Public Health, San Francisco, USA; †Department of Community Health Systems, University of California San Francisco, School of Nursing, San Francisco, USA; ‡Division of HIV/AIDS, University of California San Francisco, School of Medicine, San Francisco, USA; Departments of §Medicine; ‖Epidemiology and Biostatistics, and ¶Psychiatry, University of California San Francisco, School of Medicine, San Francisco, USA; and #San Francisco Veterans Affairs Medical Center, San Francisco, USA.
Abstract
BACKGROUND: There are no effective pharmacologic strategies for nondependent methamphetamine (meth)-using and binge-drinking men who have sex with men (MSM) at high-risk for HIV. We sought to determine the feasibility of enrolling and retaining this population in a pharmacologic trial; the acceptability of pharmacotherapy study procedures; and the tolerability of targeted naltrexone versus placebo. METHODS: Thirty meth-using and binge-drinking MSM were randomly assigned 1:1 to 50 mg naltrexone or placebo for 8 weeks for targeted administration (ie, during craving or in anticipation of meth or alcohol use). Substance use counseling and behavioral assessments were conducted every 2 weeks. Medication use was measured using WisePill dispensers. RESULTS: Trial completion was 93%; visit completion rate was 95%. Mean weekly number of medication pills taken was 2.1 and was similar between arms. Participant satisfaction rate was 96%. There were neither serious adverse events nor differences in adverse event rates between arms. In exploratory intention-to-treat analyses, there were no differences in meth use and drinking. Naltrexone participants had greater reductions in serodiscordant receptive anal intercourse [incident rate ratio (IRR) = 0.15; 95% CI = 0.05 to 0.42] and serodiscordant condomless receptive anal intercourse (IRR = 0.11; 95% CI = 0.03 to 0.37), compared with placebo. In subgroup analyses among frequent meth users, naltrexone participants had greater reductions in meth-using days (IRR = 0.78; 95% CI = 0.62 to 0.99). In as-treated analyses, frequent study medication users in the naltrexone arm had greater reductions in binge drinking days (IRR = 0.72; 95% CI = 0.54 to 0.97). CONCLUSIONS: Targeted naltrexone is a feasible, acceptable, and tolerable intervention strategy for nondependent meth-using and binge-drinking MSM. Naltrexone was associated with significant sexual risk reductions; and for some individuals, naltrexone was associated with meth and binge-drinking reductions.
RCT Entities:
BACKGROUND: There are no effective pharmacologic strategies for nondependent methamphetamine (meth)-using and binge-drinking men who have sex with men (MSM) at high-risk for HIV. We sought to determine the feasibility of enrolling and retaining this population in a pharmacologic trial; the acceptability of pharmacotherapy study procedures; and the tolerability of targeted naltrexone versus placebo. METHODS: Thirty meth-using and binge-drinking MSM were randomly assigned 1:1 to 50 mg naltrexone or placebo for 8 weeks for targeted administration (ie, during craving or in anticipation of meth or alcohol use). Substance use counseling and behavioral assessments were conducted every 2 weeks. Medication use was measured using WisePill dispensers. RESULTS: Trial completion was 93%; visit completion rate was 95%. Mean weekly number of medication pills taken was 2.1 and was similar between arms. Participant satisfaction rate was 96%. There were neither serious adverse events nor differences in adverse event rates between arms. In exploratory intention-to-treat analyses, there were no differences in meth use and drinking. Naltrexoneparticipants had greater reductions in serodiscordant receptive anal intercourse [incident rate ratio (IRR) = 0.15; 95% CI = 0.05 to 0.42] and serodiscordant condomless receptive anal intercourse (IRR = 0.11; 95% CI = 0.03 to 0.37), compared with placebo. In subgroup analyses among frequent meth users, naltrexoneparticipants had greater reductions in meth-using days (IRR = 0.78; 95% CI = 0.62 to 0.99). In as-treated analyses, frequent study medication users in the naltrexone arm had greater reductions in binge drinking days (IRR = 0.72; 95% CI = 0.54 to 0.97). CONCLUSIONS: Targeted naltrexone is a feasible, acceptable, and tolerable intervention strategy for nondependent meth-using and binge-drinking MSM. Naltrexone was associated with significant sexual risk reductions; and for some individuals, naltrexone was associated with meth and binge-drinking reductions.
Authors: Michael W Plankey; David G Ostrow; Ron Stall; Christopher Cox; Xiuhong Li; James A Peck; Lisa P Jacobson Journal: J Acquir Immune Defic Syndr Date: 2007-05-01 Impact factor: 3.731
Authors: Sakari Karhuvaara; Kaarlo Simojoki; Antti Virta; Markus Rosberg; Eliisa Löyttyniemi; Tommi Nurminen; Antero Kallio; Rauno Mäkelä Journal: Alcohol Clin Exp Res Date: 2007-04-19 Impact factor: 3.455
Authors: Eric G Benotsch; Christopher D Nettles; Felicia Wong; Jean Redmann; Jill Boschini; Steven D Pinkerton; Kathleen Ragsdale; John J Mikytuck Journal: J Community Health Date: 2007-10
Authors: Keith J Horvath; Sara Lammert; Sara LeGrand; Kathryn E Muessig; José A Bauermeister Journal: Curr Opin HIV AIDS Date: 2017-09 Impact factor: 4.283
Authors: Matthew J Mimiaga; David W Pantalone; Katie B Biello; Jackie M White Hughto; John Frank; Conall O'Cleirigh; Sari L Reisner; Arjee Restar; Kenneth H Mayer; Steven A Safren Journal: AIDS Care Date: 2019-03-19
Authors: Caitlin M Turner; Phillip Coffin; Deirdre Santos; Shannon Huffaker; Tim Matheson; Jason Euren; Anna DeMartini; Chris Rowe; Steven Batki; Glenn-Milo Santos Journal: J Subst Abuse Treat Date: 2017-01-25
Authors: Clément Palpacuer; Karima Hammas; Renan Duprez; Bruno Laviolle; John P A Ioannidis; Florian Naudet Journal: BMC Med Date: 2019-09-16 Impact factor: 8.775
Authors: Sarah Dahlberg; Ellen T Chang; Sheila R Weiss; Pamela Dopart; Errol Gould; Mary E Ritchey Journal: Diabetes Metab Syndr Obes Date: 2022-09-29 Impact factor: 3.249
Authors: Jeremy D Kidd; Margaret M Paschen-Wolff; Amy A Mericle; Billy A Caceres; Laurie A Drabble; Tonda L Hughes Journal: J Subst Abuse Treat Date: 2021-06-16