Clinical trial NCT03016598: Stimulant Oxytocin Study
Official title: 6-week Trial of Oxytocin for Co-occurring Cocaine and Opioid Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stimulant Use & Co-occuring Opioid Use Disorders
Keywords: oxytocin
substance-related disorders
Opioid Replacement Therapy
Psychophysiology
Stress Biomarkers
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-01-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: High rates of substance use disorders (SUDs) in Veterans compared to the general population are heavily influenced by psychosocial factors - such as difficulty reintegrating into civilian life due to avoidance of vital support systems - leading to disproportionately elevated unmet addiction treatment needs. Although the gold standard for treatment for most SUDs involves pharmacological interventions, there are currently no effective pharmacological interventions approved by the Federal Drug Administration for stimulant users, who have the most difficulty adhering to treatment programs and the most susceptibility to stress-induced relapse of any SUD. Administering oxytocin, a mammalian neuropeptide, intranasally to healthy controls facilitates the stress-buffering properties of social support. Oxytocin may also have an independent role in mitigating the symptoms of SUDs. For example, in animal models of addiction, oxytocin administration directly reduces tolerance, withdrawal effects, self-administration, and stress-induced reinstatement of drug seeking for a range of addictive substances. A more integrated understanding of oxytocin's distinct effects on the behavior and psychology of 1) addiction, 2) sociality, and 3) stress reactivity could be the key to defining oxytocin's role in SUD treatment. This study proposes to translate promising preclinical and early proof-of-concept clinical results related to the anti-addiction, pro-social, and stress-tempering properties of oxytocin administration in Veterans with moderate-severe stimulant use disorders enrolled in a opioid replacement therapy (ORT) program for co-occurring opioid use disorder (OUD) at the San Francisco VA Medical Center (SFVAMC). The investigators' primary outcome is Aim 1) reduction in stimulant use, as measured by stimulant positive urine drug screen. Secondarily, the investigators will focus on Aim 2) improving psychosocial treatment engagement (social support) and Aim 3) mitigating social stress-related relapse, targeting two important barriers to stimulant use disorder recovery likely to respond to oxytocin administration.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants With Stimulant Positive Drug Screen
timeFrame: Baseline, Visits 1-7, up to 7 weeks
Secondary outcomes:
measure: Working Alliance Inventory (WAI)
timeFrame: Visits 1 and 7, Up to 7 weeks
measure: Heart Rate in Response to Trier Social Stress Test (TSST).
timeFrame: Visits 1 and 7, up to 7 weeks
measure: Respiratory Rate in Response to Trier Social Stress Test (TSST).
timeFrame: Visits 1 and 7, up to 7 weeks
measure: Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
timeFrame: Visits 1 and 7, up to 7 weeks
measure: Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
timeFrame: Visits 1 and 7, up to 7 weeks
measure: Self-reported Stimulant Craving
timeFrame: Visits 1 and 7, Up to 7 weeks
measure: Individual and Group Therapy Attendance Rates
timeFrame: Visits 1-7, Up to 7 weeks
measure: Cortisol Levels in Response to Trier Social Stress Test (TSST).
timeFrame: Visits 1 and 7, up to 7 weeks
measure: Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)
timeFrame: Visits 1 and 7, up to 7 weeks
measure: Self-reported Stress/Anxiety
timeFrame: Visits 1 and 7, Up to 7 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: VA Northern California Health Care System, Mather, CA
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Christopher Stauffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.