Dataset Information

Feasibility, Acceptability, and Tolerability of Targeted Naltrexone for Nondependent Methamphetamine-Using and Binge-Drinking Men Who Have Sex with Men.

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.

SUBMITTER: Santos GM

PROVIDER: S-EPMC4837026 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Feasibility, Acceptability, and Tolerability of Targeted Naltrexone for Nondependent Methamphetamine-Using and Binge-Drinking Men Who Have Sex with Men.

Santos Glenn-Milo GM Coffin Phillip P Santos Deirdre D Huffaker Shannon S Matheson Tim T Euren Jason J DeMartini Anna A Rowe Christopher C Hahn Judith A JA Vlahov David D Vittinghoff Eric E Batki Steven L SL

Journal of acquired immune deficiency syndromes (1999) 20160501 1

<h4>Background</h4>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.<h4>Methods</h4>Thirty meth-using and binge-drinking MSM were randomly assigned 1:1 to 50 mg ...[more]

PMID: 26674372

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Project description:Background and aimsMethamphetamine use is increasingly prevalent and associated with HIV transmission. Early-phase human studies suggested naltrexone reduced amphetamine use among dependent individuals. We tested if extended-release naltrexone (XRNTX) reduces methamphetamine use and associated sexual risk behaviors among high-risk methamphetamine-dependent men who have sex with men (MSM).DesignDouble-blind, placebo-controlled, randomized trial of XRTNX versus placebo over 12 weeks from 2012 to 2015.SettingSan Francisco Department of Public Health, California, USA.ParticipantsOne hundred community-recruited, sexually-active, actively-using methamphetamine-dependent MSM. Mean age was 43.2 years; 96% were male, 3% transfemale, and 1% transmale; 55.0% were white, 19.0% African American, and 18.0% Latino.InterventionsXRNTX 380 mg (n = 50) or matched placebo (n = 50) administered by gluteal injection at 4-week intervals.MeasurementsRegression estimated average level and change in level of positive urines during the period 2-12 weeks (primary outcomes) and sexual risk behaviors (secondary outcome).FindingsNinety per cent of visits were completed. By intent-to-treat, participants assigned to XRNTX had similar differences during 2-12 weeks in methamphetamine-positive urines as participants assigned to placebo [incidence rate ratio (IRR) = 0.95, 95% confidence interval (CI) = 0.76-1.20; Bayes factor < 0.3]. Observed urine positivity declined from 78 to 70% in the XRNTX arm and 74 to 64% in the placebo arm. Adherence to injections was 96.7% in the XRNTX arm and 91.3% in the placebo arm. Sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug and no differences in frequency of adverse events by treatment arm.ConclusionsNotwithstanding very high medication adherence for this study, extended-release naltrexone does not appear to reduce methamphetamine use or sexual risk behaviors among methamphetamine-dependent men who have sex with men compared with placebo.

Project description:OBJECTIVES:To describe heavy alcohol use patterns and correlates in a diverse sample of MSM. METHODS:We used respondent-driven sampling (RDS) to enroll 252 alcohol-using MSM in San Francisco from March 2015-July 2017. We examined heavy alcohol use patterns and conducted RDS-adjusted multivariable analyses to characterize correlates of hazardous alcohol consumption and binge drinking. RESULTS:RDS-adjusted prevalence of weekly and at least weekly binge drinking was 24.9% and 19.3%, respectively. Hazardous consumption was common; prevalence of mid- and high-levels of hazardous drinking was 11.4% and 29.9%, respectively. In multivariable analyses, identifying as Hispanic/Latino or mixed/other race; being moderately or extremely interested in reducing alcohol use; ever receiving alcohol treatment; using ecstasy; reporting syphilis diagnosis; and having more than 5 male partners were independently associated with hazardous alcohol consumption. Less hazardous consumption was associated with having a bachelor's degree or completing post-graduate studies; and not being in a relationship. Reporting chlamydia infection; being somewhat, moderately or extremely interested in reducing alcohol use; and having multiple male sex partners were associated with higher odds of at least weekly binge drinking. Lower odds of binge drinking were associated with completing post-graduate studies. Moreover, for the outcomes of hazardous alcohol consumption and binge-drinking, we observed significant interaction effects between race/ethnicity and interest in reducing alcohol, past receipt of alcohol treatment, use of ecstasy, syphilis diagnosis, and number of male partners. CONCLUSION:Among alcohol-using MSM in San Francisco, heavy drinking patterns were common and independently associated with greater number of male sexual partners and sexually transmitted infections (STI). Moreover, significant racial/ethnic and socioeconomic disparities related to heavy alcohol use were observed and race/ethnicity modified the effect of the risk factors associated with these outcomes. These findings underscore the need to develop more MSM-specific interventions that jointly address heavy alcohol use and HIV/STI risk, as well as culturally-tailored and targeted strategies to alleviate health disparities.

Project description:BackgroundMen who have sex with men (MSM), including both gay and bisexual men, have a high prevalence of HIV and sexually transmitted infections (STIs) in China. However, healthcare seeking behaviors and engagement in clinical services among MSM are often suboptimal. Global evidence shows that embedding online HIV or sexual health services into gay social networking applications holds promise for facilitating higher rates of healthcare utilization among MSM. We developed a prototype of a gay-friendly health services platform, designed for integration within a popular gay social networking app (Blued) in China.ObjectiveThe purpose of this study was to evaluate the acceptability of the platform and ask for user feedback through focus group interviews with young MSM in Guangzhou and Shenzhen, cities in Southern China.MethodsThe prototype was developed through an open, national crowdsourcing contest. Open crowdsourcing contests solicit community input on a topic in order to identify potential improvements and implement creative solutions. The prototype included a local, gay-friendly, STI physician finder tool and online psychological consulting services. Semistructured focus group discussions were conducted with MSM to ask for their feedback on the platform, and a short survey was administered following discussions. Thematic analysis was used to analyze the data in NVivo, and we developed a codebook based on the first interview. Double coding was conducted, and discrepancies were discussed with a third individual until consensus was reached. We then carried out descriptive analysis of the survey data.ResultsA total of 34 participants attended four focus group discussions. The mean age was 27.3 years old (SD 4.6). A total of 32 (94%) participants obtained at least university education, and 29 (85%) men had seen a doctor at least once before. Our survey results showed that 24 (71%) participants had interest in using the online health services platform and 25 (74%) thought that the system was easy to use. Qualitative data also revealed that there was a high demand for gay-friendly healthcare services which could help with care seeking. Men felt that the platform could bridge gaps in the existing HIV or STI service delivery system, specifically by identifying local gay-friendly physicians and counselors, providing access to online physician consultation and psychological counseling services, creating space for peer support, and distributing pre-exposure prophylaxis and sexual health education.ConclusionsCrowdsourcing can help develop a community-centered online platform linking MSM to local gay-friendly HIV or STI services. Further research on developing social media-based platforms for MSM and evaluating the effectiveness of such platforms may be useful for improving sexual health outcomes.

Project description:BackgroundThe use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied.MethodsWe conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone-bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone-bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses.ResultsA total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone-bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone-bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone-bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone-bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone-bupropion during the trial.ConclusionsAmong adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo. (Funded by the National Institute on Drug Abuse and others; ADAPT-2 ClinicalTrials.gov number, NCT03078075.).

Dataset Information

Feasibility, Acceptability, and Tolerability of Targeted Naltrexone for Nondependent Methamphetamine-Using and Binge-Drinking Men Who Have Sex with Men.

Publications

Feasibility, Acceptability, and Tolerability of Targeted Naltrexone for Nondependent Methamphetamine-Using and Binge-Drinking Men Who Have Sex with Men.

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