Oxytocin HIV Meth Study

NCT ID: NCT02881177

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-07-31

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.

Conditions

Amphetamine Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Oxytocin

Oxytocin 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

40 IU

Placebo

Placebo 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

40 IU

Interventions

Oxytocin

40 IU

Intervention Type: DRUG

Placebo

40 IU

Intervention Type: DRUG

Other Intervention Names

Syntocinon; Saline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Christopher Stauffer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris Stauffer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34697392 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30791944 (View on PubMed)

Other Identifiers

16-20360

Identifier Type: -

Identifier Source: org_study_id