A Phase 1 interventional study of Oxytocin and Placebo in Amphetamine Use Disorders, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by University of California, San Francisco · Phase 1, Interventional, and Other
The purpose of this pilot study is to determine the tolerability, feasibility, and preliminary effectiveness of intranasal oxytocin administration prior to motivational enhancement group therapy sessions on laboratory-based measures of addiction, social connectedness, and stress responsivity in methamphetamine(meth)-using men who have sex with men (MSM). The investigators propose a randomized, double-blind, study of intranasal oxytocin versus placebo 40 IU prior to each of six Motivational Interviewing Group Therapy (MIGT) sessions in 28 mixed HIV sero-status MSM initiating treatment for amphetamine use disorder.
The high prevalence of amphetamine use disorder (AUD) among men who have sex with men (MSM) leads to significant health disparities, including increased risk for HIV sero-conversion. Reducing methamphetamine use mitigates HIV risk. Currently no psychopharmacological agent exists for the treatment of AUD; innovative interventions are desperately needed. Oxytocin, a social neuropeptide, has well-studied anti-addiction effects in animal models of substance dependence. The use of intranasal oxytocin for a variety of human substance use disorders is under early investigation, although no one has studied oxytocin's effects in AUD. In other populations, oxytocin's effects are known to vary depending on social context. Psychosocial treatment alone has been shown to reduce methamphetamine and HIV risk in MSM at a community-based clinic in San Francisco, The Stonewall Project. The investigators propose a randomized, double-blind pilot study of psychopharmacological-psychosocial combination therapy, administration of intranasal oxytocin versus placebo prior to six Motivational Interviewing Group Therapy (MIGT) sessions, in 28 mixed HIV sero-status MSM initiating treatment for AUD. The investigators aim to assess: 1) tolerability, 2) feasibility for larger randomized controlled trials, and 3) exploratory measures of efficacy, including: a) urine levels of methamphetamine and metabolites, b) methamphetamine craving, c) engagement in MIGT through third-party coding of videotaped group sessions and self-reported measures of group connectedness, d) psychophysiological stress responses to group engagement, and e) sexual risk taking.
31 studies on the registry are indexed under Homosexuality; 6 are open to participants now.
This study's enrollment of 48 is below the median of 263 across 28 interventional studies indexed under Homosexuality.
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Exclusion Criteria:
Oxytocin 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions.
Drug: Oxytocin
Placebo 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions.
Drug: Placebo
40 IU
Also known as: Syntocinon
40 IU
Also known as: Saline
Side effect profile
Aim 1: To examine the tolerability of repeated oxytocin dosing in MSM who use meth. Hypothesis 1: There will be no difference in side effect profiles for those receiving oxytocin (40 IU) versus placebo prior to each of six MIGT sessions, and there will be no study-related adverse events.
Time frame: 6 weeks
Recruitment Rates
Aim 2: To determine the feasibility of implementing a larger randomized controlled trial of oxytocin dosing in meth-using MSM. Hypothesis 2: This community-based pilot study will recruit and enroll 38 individuals within 6 months and have retention rates ≥75%. The investigators will collect effect size data to be used in planning the sample size of larger clinical trials. The investigators will collect pilot validation data for our exploratory measures and paradigms.
Time frame: 6 weeks
urine toxicology
Although efficacy is not the primary aim of this pilot study, following administration of 40 IU intranasal oxytocin compared to placebo prior to six MIGT sessions the investigators expect to see trends toward reduction in meth-positive urine toxicology screens.
Time frame: 6 weeks
Meth Craving Questionnaire-Brief (MCQ-Br)
Although efficacy is not the primary aim of this pilot study, following administration of 40 IU intranasal oxytocin compared to placebo prior to six MIGT sessions the investigators expect to see trends toward reduced self-reported meth craving as measured by the MCQ-Br.
Time frame: 6 weeks
attendance rate
Although efficacy is not the primary aim of this pilot study, following administration of 40 IU intranasal oxytocin compared to placebo prior to six MIGT sessions the investigators expect to see trends toward improved attendance.
Time frame: 6 weeks
Group Questionnaire
Although efficacy is not the primary aim of this pilot study, following administration of 40 IU intranasal oxytocin compared to placebo prior to six MIGT sessions the investigators expect to see trends toward increased therapeutic alliance as measured by the Group Questionnaire.
Time frame: 6 weeks
heart rate variability
Although efficacy is not the primary aim of this pilot study, following administration of 40 IU intranasal oxytocin compared to placebo prior to six MIGT sessions the investigators expect to see trends toward increased heart rate variability, a marker of parasympathetic control.
Time frame: 6 weeks
Plan to share: Undecided
The record gives a start of Jan 2017, a primary completion of Jul 2018 and a completion of Jul 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxytocin
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