Oxytocin HIV Meth Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Intranasal Oxytocin on Mixed HIV Sero-status, Methamphetamine-using Men Who Have Sex With Men

Conditions
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Amphetamine Use Disorders

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One documented urine toxicology screen positive for meth in the past month Considering initiating treatment for Methamphetamine Use Disorder or initiated treatment within the past month History of sexual contact with men. Exclusion Criteria: Urine toxicology screen positive for heroin in the past month 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 Hemodialysis or inability to produce urine samples Sensitivity to: E 216, E 218, and chlorobutanol hemihydrate (preservatives used in nasal spray) Nasal Obstruction or discharge Using Hormone supplementation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>Oxytocin 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions. | Drug: Oxytocin<br>* 40 IU<br>* Other names: Syntocinon;|
| Placebo Comparator: Placebo<br>Placebo 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions. | Drug: Placebo<br>* 40 IU<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxytocin, tolerability, HIV, men who have sex with men (MSM), addiction