Clinical trial NCT02881177: Oxytocin HIV Meth Study
Official title: The Effects of Intranasal Oxytocin on Mixed HIV Sero-status, Methamphetamine-using Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Amphetamine Use Disorders
Keywords: oxytocin
tolerability
HIV
men who have sex with men (MSM)
addiction
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. One documented urine toxicology screen positive for meth in the past month
2. Considering initiating treatment for Methamphetamine Use Disorder or initiated treatment within the past month
3. History of sexual contact with men.

Exclusion Criteria:

1. Urine toxicology screen positive for heroin in the past month
2. Meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for current psychotic disorder, severe neuropsychological disorder, current moderate-severe alcohol use disorder, or suicidal or homicidal ideation with intent within the past 90-days
3. Hemodialysis or inability to produce urine samples
4. Sensitivity to: E 216, E 218, and chlorobutanol hemihydrate (preservatives used in nasal spray)
5. Nasal Obstruction or discharge
6. Using Hormone supplementation

Primary outcomes:
measure: Side effect profile
timeFrame: 6 weeks
Secondary outcomes:
measure: Recruitment Rates
timeFrame: 6 weeks
measure: urine toxicology
timeFrame: 6 weeks
measure: Meth Craving Questionnaire-Brief (MCQ-Br)
timeFrame: 6 weeks
measure: attendance rate
timeFrame: 6 weeks
measure: Group Questionnaire
timeFrame: 6 weeks
measure: heart rate variability
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Chris Stauffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thorson KR, McKernan SM, West TV, Woolley JD, Mendes WB, Stauffer CS. Oxytocin increases physiological linkage during group therapy for methamphetamine use disorder: a randomized clinical trial. Sci Rep. 2021 Oct 25;11(1):21004. doi: 10.1038/s41598-021-99957-8.
citation: Stauffer CS, Moschetto JM, McKernan SM, Hsiang E, Borsari B, Woolley JD. Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial. Trials. 2019 Feb 21;20(1):145. doi: 10.1186/s13063-019-3225-7.