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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3225-7) contains supplementary material, which is available to authorized users.

An inverse relationship between perceived social support and substance use frequency in socially stigmatized populations

“…All participants identified methamphetamine as their substance of choice and had used at least once in the past 30 days. All participants were recently engaged in voluntary treatment for methamphetamine use disorder at a free community mental health program in San Francisco, California and were being assessed for a separate clinical trial ( Stauffer et al, 2019 ) for which the present study is an ancillary analysis.…”

Effects of Oxytocin Administration on Cue‐Induced Craving in Co‐occurring Alcohol Use Disorder and PTSD: A Within‐Participant Randomized Clinical Trial

“…Moreover, Bowen and colleagues' () finding that oxytocin blocks the effect of alcohol on critical GABA(A) receptor subtypes in rats may be reflected in clinical trial results showing beneficial effects of oxytocin on acute alcohol withdrawal, including self‐reported craving (Pedersen et al, ), and limiting alcohol ingestion over time (Pedersen, ) in individuals with AUD. Another potential role for intranasal oxytocin is as an in‐session adjunct to psychotherapy, which has been piloted in patients with PTSD (Flanagan et al, ) and substance use disorders (Stauffer et al, ). Therefore, further translational work is warranted to examine oxytocin’s potential role in alleviating acute alcohol withdrawal, reducing tolerance over time, and preventing stress‐induced relapse or other facets of excessive alcohol use in humans.…”

The vagus nerve mediates the suppressing effects of peripherally administered oxytocin on methamphetamine self-administration and seeking in rats

“…Firstly, it is crucial that sex is included as a biological variable. Currently, the only registered trial investigating the efficacy of oxytocin on METH addiction outcomes is in treatment seeking HIV-positive males 22 . As such, it should not be presumed that the results of this trial will inform the suitability of oxytocin as a therapy for females, who according to our findings, and others 43 , may be more sensitive to oxytocin treatment, and may have non-identical peripheral-to-central signaling pathways for oxytocin.…”

“…Clinical research also indicates efficacy of intranasally delivered oxytocin in reducing alcohol and marijuana cravings 19–21 . A synthesis of these preclinical and clinical findings has laid the groundwork for the first clinical trial using intranasal oxytocin in METH-dependent users 22 (NCT02881177). However, intranasal oxytocin treatment has not always been effective (see 23 for review), which raises concerns as to whether intranasal administration in humans will recapitulate the effects of peripheral administration in rodents.…”