Phase 2 N=40 Randomized Quadruple-blind Treatment

Stimulant Oxytocin Study

Stimulant Use & Co-occuring Opioid Use Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03016598 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Number of Participants With Stimulant Positive Drug Screen — 9; 12; 9; 10 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Intranasal oxytocin (Drug); Intranasal placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Stimulant Positive Drug Screen	9; 12; 9; 10; 10; 11	—
SECONDARY Working Alliance Inventory (WAI)	3.5972; 3.8182; 3.4676; 3.5208; 4.088; 3.754	—
SECONDARY Heart Rate in Response to Trier Social Stress Test (TSST).	77.252; 68.1912; 77.5306; 69.8634; 85.3146; 79.4769	—
SECONDARY Respiratory Rate in Response to Trier Social Stress Test (TSST).	10.9117; 11.2000; 11.0512; 12.292; 11.4533; 12.3352	—
SECONDARY Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).	4.2435; 4.9543; 4.6264; 4.7393; 3.5542; 3.8212	—
SECONDARY Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).	26.8196; 48.865; 28.5447; 37.7607; 22.5526; 20.9388	—
SECONDARY Self-reported Stimulant Craving	2.1667; 1.82727; 2.4389; 2.35; 2.3056; 1.8955	—
SECONDARY Individual and Group Therapy Attendance Rates	0.9352; 0.8406; 0.9333; 0.8485; 0.9241; 0.8429	—
SECONDARY Cortisol Levels in Response to Trier Social Stress Test (TSST).	0.331; 0.319; 0.283; 0.193; 0.286; 0.242	—
SECONDARY Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)	86.230; 62.695; 90.313; 52.32; 100.468; 63.471	—
SECONDARY Self-reported Stress/Anxiety	34.815; 32.2727; 46.4815; 46.0606; 36.8519; 36.97	—

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).

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03016598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.