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Summary

Eligibility
for people ages 18 years and up
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This study will investigate the effects of intranasal administration of oxytocin, a social neuropeptide, on reduction in stimulant use, enhancing group cohesion and therapeutic engagement, and susceptibility to stress-induced relapse in Veterans with stimulant use disorder.

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. 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. Moreover, oxytocin plays a role in modulating the hypothalamic-pituitary-adrenal (HPA) axis, which is involved in stress-induced SUD relapse. While results of early translational work in oxytocin and SUDs in humans, including my own pilot work, have been promising, findings have varied based on social context. 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 is particularly relevant to Veterans with SUDs, who are at a disadvantage due to increased rates of comorbid avoidant attachment - a measurable personality variant defined by avoidance of social intimacy and overvalued independence - and posttraumatic stress symptoms preventing retention in existing SUD treatment paradigms and heightening vulnerability to stress-induced substance use. This study will uniquely combine psychopharmacological and evidence-based psychosocial interventions targeted at improving sociality, treatment engagement, and stress responsivity to enhance overall recovery among Veterans with SUDs.

Keywords

Stimulant Use Disorder oxytocin substance-related disorders Motivational Interviewing Psychophysiology Psychotherapeutic processes Central Nervous System Stimulants

Eligibility

You can join if…

Open to people ages 18 years and up

  1. At least 18 years old
  2. One documented urine toxicology screen positive for stimulants within the past month
  3. Stimulant use disorder (must be primary substance use disorder with the exception of nicotine)
  4. Veteran

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 chlorbutanol 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
January 1, 2017
I’m interested in this study!