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Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:The prevalence of methamphetamine use disorder (MUD) in the United States has risen dramatically in the past four decades and is concentrated in populations such as men who have sex with men (MSM). Despite the public health consequences of MUD, there are no FDA-approved psychopharmacological treatments. Psychosocial treatment alone has been shown to reduce methamphetamine use, but high attrition rates limit treatment efficacy. Promising findings from animal models of MUD using exogenous oxytocin, a social neuropeptide, have set the stage for translational work. Along with unique anti-addiction effects, oxytocin holds a primary role in enhancing social salience and modulating stress. In humans, oxytocin administration, combined with evidence-based psychosocial interventions, may act synergistically to improve addiction treatment outcomes and improve retention rates in current MUD treatment. METHODS/DESIGN:We are conducting a randomized, double-blind, placebo-controlled trial of oxytocin-enhanced motivational interviewing group therapy (MIGT). Oxytocin or placebo 40 IU is administered intranasally in conjunction with six, weekly MIGT sessions. We will recruit 50 MSM, initiating treatment for MUD from specialized community health programs in San Francisco, CA, USA. Individuals will be randomized (1:1) to receive six, weekly sessions of MIGT with or without oxytocin. Our primary outcome is session attendance. Other outcomes of interest include: measures of group cohesion, anxiety, psychophysiology, and stimulant craving and use. DISCUSSION:This will be the first study of oxytocin's effects in humans with MUD. Findings from this novel protocol will attempt to bridge existing animal data with the need for innovative clinical treatments for MUD, inform the growing field of pharmacologically-enhanced psychotherapy, and help to elucidate mechanisms behind oxytocin's potential anti-addiction effects. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02881177 . Registered on 26 August 2016.

SUBMITTER: Stauffer CS

PROVIDER: S-EPMC6385415 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial.

Stauffer Christopher S CS Moschetto Jenna M JM McKernan Scott M SM Hsiang Elaine E Borsari Brian B Woolley Joshua D JD

Trials 20190221 1

<h4>Background</h4>The prevalence of methamphetamine use disorder (MUD) in the United States has risen dramatically in the past four decades and is concentrated in populations such as men who have sex with men (MSM). Despite the public health consequences of MUD, there are no FDA-approved psychopharmacological treatments. Psychosocial treatment alone has been shown to reduce methamphetamine use, but high attrition rates limit treatment efficacy. Promising findings from animal models of MUD using ...[more]

PMID: 30791944

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Project description:BackgroundMethamphetamine (METH) use is a public health crisis that disproportionately affects men who have sex with men (MSM). There are currently no FDA-approved pharmacological interventions to treat methamphetamine use disorder (MUD). MUD is associated with social impairments and extremely high treatment attrition rates. Administration of oxytocin, a neuropeptide involved in social attachment, may be a novel approach to addressing these issues. Moreover, oxytocin administration has shown promise for reducing METH-related addictive behavior in animal models, but has not yet been investigated in clinical trials for MUD. Last, oxytocin is known to modulate stress responsivity via regulation of the autonomic nervous system, which is dysregulated in METH users. We hypothesize that oxytocin, in combination with group psychotherapy, will increase treatment engagement, reduce addiction behavior, and mitigate stress hyperreactivity.MethodsThis is a randomized, double blind trial of oxytocin 40-IU (n = 24) or placebo (n = 24) administered intranasally prior to each of six weekly motivational interviewing group therapy (MIGT) sessions for MUD in MSM.Primary outcome(a) session attendance.Secondary outcomes(b) group cohesion, (c) anxiety, (d) METH craving, (e) METH use, and (f) in-session cardiac physiology.ResultsParticipants receiving oxytocin had significantly higher group therapy attendance than those receiving placebo, OR 3.26, 95% CI [1.27-8.41], p = .014. There was a small effect of oxytocin on group cohension, but not anxiety or craving. METH use did not change over the six-week MIGT course in either treatment arm. Participants receiving oxytocin had lower average heart rates during MIGT sessions and higher heart rate variability. There were positive main effects of MIGT over Time regardless of study drug.ConclusionsThis evidence, and the lack of any serious adverse events, suggests that oxytocin may safely increase treatment attendance. One possible mechanism by which it may do so is its modulation of the autonomic nervous system. Further investigation is warranted.

Project description:BackgroundMen who have sex with men (MSM) currently account for more than two-thirds of new HIV diagnoses in the United States and, among young MSM (YMSM) aged 20 to 29 years, as many as 79% to 84% of new infections occur between primary partners. Contributing to HIV risk, YMSM use drugs at comparatively high rates. To date, no interventions have been developed that specifically address the unique needs of partnered YMSM or incorporate a focus on relationship factors in addressing personal motivation for change.ObjectiveThe study's primary aim is to evaluate the efficacy of the PARTNER intervention and evaluate potential moderators or mediators of intervention effects. The study's secondary aims were to gather ideographic data to inform a future effectiveness implementation study and develop a novel biomarker for pre-exposure prophylaxis (PrEP) adherence by analyzing PrEP drug levels in fingernails.MethodsPARTNER is a 4-session motivational interviewing-based intervention that integrates video-based communication training to address drug use and HIV prevention among partnered YMSM. This study utilizes a randomized controlled trial design to compare the PARTNER intervention with an attention-matched psychoeducation control arm that provides information about HIV-risk reduction, PrEP, and substance use. Participants are randomized in a 1-to-1 ratio stratified on age disparity between partners, racial composition of the couple, and relationship length. Follow-up assessments are conducted at 3-, 6-, 9-, and 12-months postbaseline. The study recruits and enrolls 240 partnered YMSM aged between 18 to 29 years at a research center in New York City. Participants will be HIV-negative and report recent (past 30-day) drug use and condomless anal sex with casual partners; a nonmonogamous primary partner (regardless of HIV status); or a serodiscordant primary partner (regardless of sexual agreement). Primary outcomes (drug use and HIV sexual transmission risk behavior) are assessed via a Timeline Follow-back interview. Biological markers of outcomes are collected for drug use (fingernail assay), sexual HIV transmission risk (rectal and urethral gonorrhea and chlamydia testing), and PrEP adherence (dried blood spots and fingernails for a novel PrEP drug level assay).ResultsThe study opened for enrollment in February 2018. Anticipated completion of enrollment is October 2021. Primary outcome analyses will begin after final follow-up completion.ConclusionsExisting research on partnered YMSM within the framework of Couples Interdependence Theory (CIT) has suggested that relationship factors (eg, dyadic functioning and sexual agreements) are meaningfully related to drug use and HIV transmission risk. Results pertaining to the efficacy of the proposed intervention and the identification of putative moderators and mediators will substantially inform the tailoring of interventions for YMSM in relationships and contribute to a growing body of relationship science focused on enhancing health outcomes.Trial registrationClinicalTrials.gov NCT03396367; https://clinicaltrials.gov/ct2/show/NCT03396367 (Archived by WebCite at http://www.webcitation.org/78ti7esTc.International registered report identifier (irrid)DERR1-10.2196/13015.

Project description:BackgroundMethamphetamine (meth) use among men who have sex with men (MSM) is associated with increased HIV prevalence and transmission and substandard advancement along the HIV prevention and care continuum. Given the growth of mobile health (mHealth) technologies, it is no longer necessary to limit meth treatment options to physical, brick-and-mortar sites, and administration using generic, nontailored content.ObjectiveIn a 2-arm randomized controlled trial (RCT; N=300), we aim to evaluate the use of an mHealth intervention (Getting Off) to assess the impact and noninferiority of a cross-platform app (developed from a manualized meth treatment intervention) to help MSM reduce meth use and HIV sexual risk behaviors and improve their advancement along the HIV prevention and care continuum (HIV testing, pre-exposure prophylaxis uptake and persistence, and antiretroviral therapy uptake and adherence).MethodsParticipants will be randomized into 2 arms: arm A, with immediate access to the app (immediate delivery: n=150), or arm B, with delayed access to the app after a 30-day period (delayed delivery: n=150). Participants in both arms will use the same Getting Off app and will have 30 days to complete the 24 sessions. Participants will be assessed at the 1-, 2- (delayed delivery arm only), 3-, 6-, and 9-month timepoints to determine observed treatment effects and will be compared with a historical matched sample of participants (n=~600) who received the brick-and-mortar group-based Getting Off intervention.ResultsRecruitment began in January 2019 for phase 1, the formative phase. In January and February 2019, 4 focus groups (N=36) were formed to provide input on the adaptation of the group-based manual intervention to a mobile app. Data collection for phase 2, the RCT, is expected to be completed in January 2023. The final results are anticipated in April 2023.ConclusionsBy creating a culturally responsive mobile app, Getting Off aims to reduce meth use and improve sexual health outcomes among meth-using MSM. The Getting Off app could have significant public health impact by greatly expanding access to effective, affordable, private, culturally competent, and highly scalable meth treatment for MSM.Trial registrationClinicaltrials.gov NCT03884946; https://clinicaltrials.gov/ct2/show/NCT03884946.International registered report identifier (irrid)DERR1-10.2196/22572.

Project description:BackgroundHuman papillomavirus (HPV) vaccination is effective in the prevention of vaccine-type genital warts and cancers among men who have sex with men (MSM).ObjectiveThe primary objective of this randomized controlled trial (RCT) is to evaluate the efficacies of 2 web- and theory-based interventions with and without brief motivational interviewing (MI) over the phone to increase the completion of HPV vaccination among unvaccinated participants within a 24-month follow-up period compared with the control group.MethodsA 3-arm parallel-group RCT was conducted between July 2017 and December 2019. Five telephone surveys were conducted at baseline and at 3, 6, 9, and 24 months by blinded interviewers. Participants were Hong Kong Chinese-speaking MSM aged between 18 and 45 years with regular internet access who were recruited from outreaching at venues, web-based recruitment, and peer referral. Those who had ever received HPV vaccination were excluded. A total of 624 participants were randomized into either the online tutorial (OT) only group (n=208), the OT plus MI group (OT-MI; n=208), or the control group (n=208). In total, 459 (459/624, 73.6%) completed the follow-up evaluation at 24 months. Participants in the OT group received a fully automated OT developed based on the health belief model. On top of the same OT, the OT-MI group received brief MI over the phone. Reminders were sent to the participants of the OT and OT-MI groups after 1, 2, 4, 6, and 8 months. Participants in the control group received web-based health communication messages unrelated to HPV or HPV vaccination. The research team validated the self-reported HPV vaccination uptake. Intention-to-treat analysis was used for outcome analyses. Logistic regression models and multivariable linear regression models were used to test the between-group differences in primary and secondary outcomes. Baron and Kenny's methods were used to test the mediation hypothesis.ResultsThe participants in the OT-MI group reported a significantly higher validated completion of HPV vaccination at 24 months than the control group (36/208, 17.3% vs 15/208, 7.2%; P=.006). However, the difference in HPV vaccination completion between the OT and the control groups (24/208, 11.5% vs 15/208, 7.2%; P=.17), or between OT-MI and OT groups (P=.13), was not statistically significant. The association between randomization status (OT-MI group vs control group) and HPV vaccination completion became statistically nonsignificant after controlling for changes in the perceived susceptibility to HPV (24 months vs baseline), whereas perceived susceptibility remained strongly associated with HPV vaccination uptake in the model (P<.001). Changes in perceived susceptibility fully mediated the intervention effect.ConclusionsTheory-based OT with brief MI over the phone was effective in increasing HPV vaccination completion among Chinese MSM. Perceived susceptibility is an active theoretical component that causes behavioral changes.Trial registrationClinicalTrials.gov NCT03286907; https://clinicaltrials.gov/ct2/show/NCT03286907.

Dataset Information

Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial.

Publications

Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial.

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