Oxytocin HIV Meth Study

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Oxytocin

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