Stimulant Oxytocin Study

Overview

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).

Full Title of Study: “6-week Trial of Oxytocin for Co-occurring Cocaine and Opioid Use Disorders”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 27, 2019

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 quantitative urine levels of cocaine and amphetamine metabolites. 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.

Interventions

  • Drug: Intranasal oxytocin
    • Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin 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.
  • Drug: Intranasal placebo
    • 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.

Arms, Groups and Cohorts

  • Experimental: Oxytocin
    • 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.
  • Placebo Comparator: Placebo
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • quantitative levels of cocaine and amphetamine metabolites in urine
    • Time Frame: Up to 6 weeks
    • Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use.

Secondary Measures

  • Working Alliance Inventory (WAI)
    • Time Frame: Up to 6 weeks
    • Aim 2: To evaluate the effectiveness of intranasal oxytocin on improving psychosocial treatment engagement (social support) as measured by the WAI, an inventory of therapeutic alliance.
  • Psychophysiological measures
    • Time Frame: up to 6 weeks
    • Aim 3: To evaluate the effectiveness of intranasal oxytocin on reducing stress-related psycho-physiological measures in response to the trier social stress test (TSST).
  • Self-reported stimulant craving
    • Time Frame: Up to 6 weeks
    • Aim 4: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant craving in response the TSST.
  • Individual and Group therapy attendance Rates
    • Time Frame: Up to 6 weeks
    • Aim 5: To evaluate the effectiveness of intranasal oxytocin on improving psychosocial treatment engagement (social support) as measured by individual and group therapy attendance rates.
  • Stress Biomarkers
    • Time Frame: up to 6 weeks
    • Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST.
  • Self-reported stress/anxiety
    • Time Frame: Up to 6 weeks
    • Aim 7: To evaluate the effectiveness of intranasal oxytocin on reducing self-reported stress/anxiety levels in response to the TSST.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christopher Stauffer, MD, Principal Investigator, San Francisco VA Medical Center, San Francisco, CA
  • Overall Contact(s)
    • Christopher Stauffer, MD, (415) 221-4810, Christopher.Stauffer@va.gov

References

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.

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