Abstract
BackgroundThe 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/designWe 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.DiscussionThis 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 registrationClinicalTrials.gov, ID: NCT02881177. Registered on 26 August 2016.
Highlights
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)
Methamphetamine is associated with impairments in social cognition and theory of mind, including a hypersensitivity to social threat, which likely contribute to reduced treatment adherence and retention [16,17,18,19]
We aim to investigate the effectiveness of intranasally administered oxytocin on motivational interviewing group therapy (MIGT) treatment engagement
Summary
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). Psychosocial treatment alone has been shown to reduce methamphetamine use, but high attrition rates limit treatment efficacy. The prevalence of methamphetamine use disorder (MUD) in the US has risen dramatically in the past four decades, with high concentrations among men who have sex with men (MSM) [4,5,6]. Methamphetamine users exhibit high attrition rates of 60% or more, which limits the effectiveness of treatment and leads to missing data and validity issues in clinical research contexts [14]. This complicates efforts to identify pharmacotherapy candidates or to improve evidence-based psychosocial treatments for MUD [8, 15]. Given the social complexities and challenges surrounding MUD clinical treatment and research, an adjunctive pharmacotherapy that might enhance social cognition and boost engagement and retention in effective psychosocial treatment could greatly improve outcomes [23]
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