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Trial · Interventional

CompletedPhase 1Registry data

Oxytocin HIV Meth Study

Short name OHM

NCTNCT02881177 (opens ClinicalTrials.gov in a new tab)Other id16-20360
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
48 participants (actual)
Sponsor
University of California, San Francisco · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jan 2017
Primary completion
Jul 2018
Completion
Jul 2018
First posted
26 Aug 2016 (estimated)
Last update posted
5 Mar 2019
Conditions
Amphetamine Use Disorders

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 1

    OHM

    NCT02881177

    Jan 2017 to Jul 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Oxytocin

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

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Side effect profile

    Time frame · 6 weeks

    Registry description

    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.

Secondary outcomes(6)

  1. Recruitment Rates

    Time frame · 6 weeks

    Registry description

    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.

  2. urine toxicology

    Time frame · 6 weeks

    Registry description

    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.

  3. Meth Craving Questionnaire-Brief (MCQ-Br)

    Time frame · 6 weeks

    Registry description

    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.

  4. attendance rate

    Time frame · 6 weeks

    Registry description

    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.

  5. Group Questionnaire

    Time frame · 6 weeks

    Registry description

    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. heart rate variability

    Time frame · 6 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

3 results

Oxytocin increases physiological linkage during group therapy for methamphetamine use disorder: a randomized clinical trial.

Thorson et al. 2021Scientific reportscited by 10

PMID 34697392PMC8546069DOI 10.1038/s41598-021-99957-8PUB-34697392

CC BY3 results
Download PDFSee results (3)

Indexing hint: Clinical trial · 2019

Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial.

Stauffer et al. 2019Trialscited by 14

PMID 30791944PMC6385415DOI 10.1186/s13063-019-3225-7PUB-30791944

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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