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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:

Description

Summary

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

Official Title

6-week Trial of Oxytocin for Co-occurring Cocaine and Opioid Use Disorders

Details

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 cocaine use disorder (CUD) enrolled in a methadone maintenance therapy (MMT) program for cooccurring opioid use disorder (OUD) at the San Francisco VA Medical Center (SFVAMC). The investigators' primary outcome is Aim 1) reduction in cocaine use, as measured by quantitative urine levels of cocaine metabolite. 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 CUD recovery likely to respond to oxytocin administration

Keywords

Cocaine Use & Co-occuring Opioid Use Disorders oxytocin substance-related disorders Methadone Maintenance Therapy Psychophysiology Stress Biomarkers Methadone Cocaine

Eligibility

You can join if…

Open to people ages 18 years and up

  1. At least 18 years old
  2. Enrolled as a patient at the SFVAMC Opioid Treatment Program
  3. Stable dose of methadone for at least 2 consecutive weeks
  4. Veteran
  5. One documented urine toxicology screen positive for cocaine in the past month

You CAN'T join if...

  1. DSM-V criteria for previous or current schizophrenia, schizoaffective disorder, or bipolar disorder; severe neuropsychological disorder, premenstrual dysphoric disorder,or current moderate-severe alcohol use disorder
  2. Suicidal or homicidal ideation within the past 90 days or a suicide attempt in the past 6 months
  3. Hemodialysis
  4. Sensitivity to E216, E218, and chlorobutanol hemihydrate (preservatives in nasal spray)
  5. Using hormone supplementation
  6. Using 5HT1a agonist/antagonist
  7. Positive urine pregnancy test or women of childbearing age not practicing effective means of non-hormonal birth control
  8. Chronic nasal obstruction, discharge, or bleeding

Location

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
Links
Click here for more information about this study: 6-week trial of oxytocin for co-occurring cocaine and opioid use disorders
ID
NCT03016598
Phase
Phase 2
Lead Scientist
Christopher Stauffer
Study Type
Interventional
Last Updated
July 1, 2017
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