NCT03016598

Brief Summary

This study will investigate the effects of intranasal administration of oxytocin, a social neuropeptide, on reducing stimulant use, enhancing therapeutic engagement, and susceptibility to stress-induced relapse in Veterans with stimulant use disorders and enrolled in opioid replacement therapy (ORT) program for co-occurring opioid use disorder (OUD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

January 26, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2020

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 10, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

2.1 years

First QC Date

January 4, 2017

Results QC Date

February 18, 2021

Last Update Submit

June 8, 2021

Conditions

Stimulant Use & Co-occuring Opioid Use Disorders

Keywords

oxytocinsubstance-related disordersOpioid Replacement TherapyPsychophysiologyStress Biomarkers

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Stimulant Positive Drug Screen

    Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use.

    Baseline, Visits 1-7, up to 7 weeks

Secondary Outcomes (10)

  • Working Alliance Inventory (WAI)

    Visits 1 and 7, Up to 7 weeks

  • Heart Rate in Response to Trier Social Stress Test (TSST).

    Visits 1 and 7, up to 7 weeks

  • Respiratory Rate in Response to Trier Social Stress Test (TSST).

    Visits 1 and 7, up to 7 weeks

  • Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).

    Visits 1 and 7, up to 7 weeks

  • Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).

    Visits 1 and 7, up to 7 weeks

  • +5 more secondary outcomes

Study Arms (2)

Oxytocin

EXPERIMENTAL

Patients in methadone maintenance treatment (MMT) programs are required to come in every day for their methadone. Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions. The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring opioid use disorder (OUD) to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.

Drug: Intranasal oxytocin

Placebo

PLACEBO COMPARATOR

Patients in MMT programs are required to come in every day for their methadone. Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions. The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring OUD to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.

Drug: Intranasal placebo

Interventions

Intranasal oxytocinDRUG

Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin nasal spray 40 International Units (IU) to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.

Also known as: Syntocinon
Oxytocin
Intranasal placeboDRUG

Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a placebo nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.

Also known as: Saline placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years old
  • Enrolled as a patient who at the SFVAMC Opioid Treatment Program or the Oakland Behavioral Health Clinic Opioid Treatment Program
  • Stable dose of opioid replacement therapy for at least 2 consecutive weeks
  • Veteran
  • One documented urine toxicology screen positive for stimulants in the past 12 months.

You may not qualify if:

  • Severe neuropsychological disorder
  • Suicidal or homicidal ideation within the past 90 days or a suicide attempt in the past 6 months
  • Hemodialysis, unless participant can produce urine samples weekly
  • Sensitivity to methylparaben or propylparaben
  • Positive urine pregnancy test or women of childbearing age not practicing effective means of non-hormonal birth control
  • Chronic nasal obstruction, discharge, or bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Stauffer CS, Woolley JD. Can we bottle psychosocial treatments for addiction? The role of oxytocin. J Clin Psychiatry. 2014 Sep;75(9):1028-9. doi: 10.4088/JCP.14ac09437. No abstract available.

    PMID: 25295428BACKGROUND

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Delaney.McKechnie@va.gov
Organization
Portland VA
Delaney.McKechnie@va.gov
360-696-4061

Study Officials

  • Christopher Stauffer, MD

    San Francisco VA Medical Center, San Francisco, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 10, 2017

Study Start

January 26, 2018

Primary Completion

February 14, 2020

Study Completion

February 14, 2020

Last Updated

June 10, 2021

Results First Posted

June 10, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)