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Completed

NCT Number: NCT02028533

Cocaine Opioid Oxytocin Option - Limited

This is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.

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Key information

Conditions

Opioid Use Disorder Behavior Behavior, Addictive Chemically-Induced Disorders Cocaine Use Disorder Compulsive Behavior Impulsive Behavior Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

San Francisco General Hospital Opiate Treatment Outpatient Program

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled as a patient in the San Francisco General Hospital Opioid Treatment Outpatient Program
  • Stable dose of methadone for at least the past two weeks
  • At least one routine urine toxicology screen positive for cocaine in the past month

Exclusion criteria

  • Positive urine pregnancy test
  • Use of illicit drugs in the past month (with the exception of cocaine or cannabis)
  • Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions
  • History of psychotic or moderate-severe alcohol use disorder as defined by DSM-V criteria
  • Severe neuropsychological disorder, brain trauma, epilepsy
  • Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)
  • Nasal obstruction, discharge, or bleeding
  • Habitually drinks large volumes of water
  • Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists

Treatment and study plan

Oxytocin

Drug

Other names: oxytocin nasal spray, Syntocinon

Placebo

Drug

Other names: placebo nasal spray

Primary outcomes

  1. Number of patients with non-serious and serious adverse events

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Chronic Intranasal Oxytocin as an Adjunct to Methadone Maintenance Treatment in Patients With Co-occuring Opioid Use Disorder and Cocaine Use: A 2-week Pilot Study

Acronym: COOOL

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2014
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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