Amphetamine Use DisordersPhase 1OHMNCT02881177
Oxytocin HIV Meth Study
A Phase 1 study testing Oxytocin in people with Amphetamine Use Disorders, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Amphetamine Use Disorders
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94102
About this study
Official title: The Effects of Intranasal Oxytocin on Mixed HIV Sero-status, Methamphetamine-using Men Who Have Sex With Men
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.
Read the 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
- Being tested
- Oxytocin, Placebo
- Keywords
- oxytocin, tolerability, HIV, men who have sex with men (MSM), addiction
- Medical subject headings
- Homosexuality, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
40 IU
PlaceboDrug
Also called Saline
40 IU
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Oxytocin 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions. Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Placebo 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amphetamine Use DisordersStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Stauffer, University of California, San Francisco
- Investigators
- Chris Stauffer, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881177
- Sponsor's protocol ID
- 16-20360
- Acronym
- OHM
- Status last verified
- Mar 2019
- First submitted
- 22 Aug 2016
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34697392Stauffer 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.
PubMed 30791944
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intranasal Oxytocin on Mixed HIV Sero-status, Methamphetamine-using Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT02881177
- Acronym / sponsor ID
- OHM / 16-20360
- Conditions
- Amphetamine Use Disorders
- Keywords
- oxytocin, tolerability, HIV, men who have sex with men (MSM), addiction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinOxytocin 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: Syntocinon40 IU | Drug | Oxytocin |
| PlaceboAlso: Saline40 IU | Drug | Placebo |
Primary outcome
Side effect profile
Time frame: 6 weeks
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 secondary outcomes
Recruitment Rates
Time frame: 6 weeks
urine toxicology
Time frame: 6 weeks
Meth Craving Questionnaire-Brief (MCQ-Br)
Time frame: 6 weeks
attendance rate
Time frame: 6 weeks
Group Questionnaire
Time frame: 6 weeks
heart rate variability
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Derived from this study: PubMed 34697392Thorson 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.
- Derived from this study: PubMed 30791944Stauffer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Stauffer, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Amphetamine Use Disorders, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effect profile (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881177, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.