Feasibility, acceptability and tolerability of targeted naltrexone for non-dependent methamphetamine-using and binge-drinking men who have sex with men

Glenn Milo Santos, Phillip Coffin, Deirdre Santos, Shannon Huffaker, Tim Matheson, Jason Euren, Anna DeMartini, Christopher Rowe, Judith A. Hahn, David Vlahov, Eric Vittinghoff, Steven L. Batki

Research output: Contribution to journalArticle

Abstract

BACKGROUND:: There are no effective pharmacologic strategies for non-dependent methamphetamine (meth)-using and binge-drinking 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 50mg naltrexone or placebo for 8 weeks for targeted administration (i.e., during craving or in anticipation of meth or alcohol use). Substance use counseling and behavioral assessments were conducted every two 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 2.2 and was similar between arms. Participant satisfaction rate was 96%. There were no 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 (IRR=0.15; 95%CI=0.05-0.42) and serodiscordant condomless receptive anal intercourse (IRR=0.11; 95%CI=0.03-0.37), compared to placebo. In subgroup analyses among frequent meth-users, naltrexone participants had greater reductions in meth-using days (IRR=0.78; 95%CI=0.62-0.99). In as-treated analyses, frequent study medication users in the naltrexone arm had greater reductions in binge drinking days (IRR=0.72; 95%CI=0.54-0.97). CONCLUSIONS:: Targeted naltrexone is a feasible, acceptable and tolerable intervention strategy for non-dependent 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.

Original languageEnglish (US)
JournalJournal of Acquired Immune Deficiency Syndromes
DOIs
StateAccepted/In press - Dec 15 2015
Externally publishedYes

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Binge Drinking
Naltrexone
Methamphetamine
Placebos
Intention to Treat Analysis
Risk Reduction Behavior
Drinking
Counseling
Alcohols
HIV
Drug Therapy
insulin receptor-related receptor

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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Feasibility, acceptability and tolerability of targeted naltrexone for non-dependent methamphetamine-using and binge-drinking men who have sex with men. / Santos, Glenn Milo; Coffin, Phillip; Santos, Deirdre; Huffaker, Shannon; Matheson, Tim; Euren, Jason; DeMartini, Anna; Rowe, Christopher; Hahn, Judith A.; Vlahov, David; Vittinghoff, Eric; Batki, Steven L.

In: Journal of Acquired Immune Deficiency Syndromes, 15.12.2015.

Research output: Contribution to journalArticle

Santos, Glenn Milo ; Coffin, Phillip ; Santos, Deirdre ; Huffaker, Shannon ; Matheson, Tim ; Euren, Jason ; DeMartini, Anna ; Rowe, Christopher ; Hahn, Judith A. ; Vlahov, David ; Vittinghoff, Eric ; Batki, Steven L. / Feasibility, acceptability and tolerability of targeted naltrexone for non-dependent methamphetamine-using and binge-drinking men who have sex with men. In: Journal of Acquired Immune Deficiency Syndromes. 2015.
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abstract = "BACKGROUND:: There are no effective pharmacologic strategies for non-dependent methamphetamine (meth)-using and binge-drinking 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 50mg naltrexone or placebo for 8 weeks for targeted administration (i.e., during craving or in anticipation of meth or alcohol use). Substance use counseling and behavioral assessments were conducted every two 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 2.2 and was similar between arms. Participant satisfaction rate was 96{\%}. There were no 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 (IRR=0.15; 95{\%}CI=0.05-0.42) and serodiscordant condomless receptive anal intercourse (IRR=0.11; 95{\%}CI=0.03-0.37), compared to placebo. In subgroup analyses among frequent meth-users, naltrexone participants had greater reductions in meth-using days (IRR=0.78; 95{\%}CI=0.62-0.99). In as-treated analyses, frequent study medication users in the naltrexone arm had greater reductions in binge drinking days (IRR=0.72; 95{\%}CI=0.54-0.97). CONCLUSIONS:: Targeted naltrexone is a feasible, acceptable and tolerable intervention strategy for non-dependent 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.",
author = "Santos, {Glenn Milo} and Phillip Coffin and Deirdre Santos and Shannon Huffaker and Tim Matheson and Jason Euren and Anna DeMartini and Christopher Rowe and Hahn, {Judith A.} and David Vlahov and Eric Vittinghoff and Batki, {Steven L.}",
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T1 - Feasibility, acceptability and tolerability of targeted naltrexone for non-dependent methamphetamine-using and binge-drinking men who have sex with men

AU - Santos, Glenn Milo

AU - Coffin, Phillip

AU - Santos, Deirdre

AU - Huffaker, Shannon

AU - Matheson, Tim

AU - Euren, Jason

AU - DeMartini, Anna

AU - Rowe, Christopher

AU - Hahn, Judith A.

AU - Vlahov, David

AU - Vittinghoff, Eric

AU - Batki, Steven L.

PY - 2015/12/15

Y1 - 2015/12/15

N2 - BACKGROUND:: There are no effective pharmacologic strategies for non-dependent methamphetamine (meth)-using and binge-drinking 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 50mg naltrexone or placebo for 8 weeks for targeted administration (i.e., during craving or in anticipation of meth or alcohol use). Substance use counseling and behavioral assessments were conducted every two 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 2.2 and was similar between arms. Participant satisfaction rate was 96%. There were no 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 (IRR=0.15; 95%CI=0.05-0.42) and serodiscordant condomless receptive anal intercourse (IRR=0.11; 95%CI=0.03-0.37), compared to placebo. In subgroup analyses among frequent meth-users, naltrexone participants had greater reductions in meth-using days (IRR=0.78; 95%CI=0.62-0.99). In as-treated analyses, frequent study medication users in the naltrexone arm had greater reductions in binge drinking days (IRR=0.72; 95%CI=0.54-0.97). CONCLUSIONS:: Targeted naltrexone is a feasible, acceptable and tolerable intervention strategy for non-dependent 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.

AB - BACKGROUND:: There are no effective pharmacologic strategies for non-dependent methamphetamine (meth)-using and binge-drinking 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 50mg naltrexone or placebo for 8 weeks for targeted administration (i.e., during craving or in anticipation of meth or alcohol use). Substance use counseling and behavioral assessments were conducted every two 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 2.2 and was similar between arms. Participant satisfaction rate was 96%. There were no 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 (IRR=0.15; 95%CI=0.05-0.42) and serodiscordant condomless receptive anal intercourse (IRR=0.11; 95%CI=0.03-0.37), compared to placebo. In subgroup analyses among frequent meth-users, naltrexone participants had greater reductions in meth-using days (IRR=0.78; 95%CI=0.62-0.99). In as-treated analyses, frequent study medication users in the naltrexone arm had greater reductions in binge drinking days (IRR=0.72; 95%CI=0.54-0.97). CONCLUSIONS:: Targeted naltrexone is a feasible, acceptable and tolerable intervention strategy for non-dependent 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.

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