Cocaine Opioid Oxytocin Option - Limited

NCT02028533 | Completed Phase 1 DMC

• 1 other identifier: 13-12534
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder; Cocaine Use Disorder

Keywords

addiction; oxytocin; tolerability

Outcome Measures

Primary Outcomes (1)

• Number of patients with non-serious and serious adverse events

  3 weeks

Study Arms (2)

Patients 1

ACTIVE COMPARATOR

Participants will receive intranasal oxytocin 40 International Units (IU).

Drug: Oxytocin

Patients 2

PLACEBO COMPARATOR

Participants will receive 40 International Units of intranasal placebo.

Drug: Placebo

Interventions

Oxytocin DRUG

Also known as: oxytocin nasal spray, Syntocinon

Patients 1

Placebo DRUG

Also known as: placebo nasal spray

Patients 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital Opiate Treatment Outpatient Program

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Christopher S Stauffer, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Joshua Woolley, MD, PhD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 7, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

US (1)