Oxytocin Treatment of Opioid Dependence

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: The purpose of this research study is to learn whether oxytocin treatment decreases use of and cravings for opioids (narcotics) in people who have been using opioids heavily for long periods of time and are unable to stop on their own.

Participants: Patients meeting DSM-IV-TR criteria for opioid dependence.

Procedures (methods): Subjects will have standard medications available for withdrawal symptoms from opioids and standard psychosocial interventions available in the inpatient setting. In addition, subjects will self-administer intranasal test treatments 3 times daily.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Analgesics, Opioid; Oxytocin

Criteria

Inclusion Criteria:

1. Age 21-45.

2. Regular opioid use (daily or nearly daily) for at least 6 months (subjective report).

3. Active DSM-IV diagnosis of opioid dependence.

Exclusion Criteria:

1. Meets DSM-IV criteria for dependence on psychoactive substances other than opioids, caffeine or nicotine within 6 months prior to screening.

2. Treatment with naltrexone in the last month.

3. History of a significant psychiatric illness including: lifetime history of mania requiring hospitalization, psychotic disorder, cognitive disorder; history during the last two years of eating disorder. Standing or as needed non-exclusionary medications for non-exclusionary psychiatric disorders will be permitted.

4. Unstable medical illness that could compromise consent to treatment, interfere with evaluation of study medication, or present a safety concern (e.g. uncontrolled diabetes mellitus, unstable hypertension, BMI <18 or >35, seizure disorder, traumatic brain injury, Parkinson's disease, AIDS). Adequately controlled conditions (such as diabetes mellitus, hypertension, asthma, HIV infection, and hepatitis C) will not be exclusionary. Standing or or as needed medications for non-exclusionary medical conditions will be permitted.

5. Serum sodium < 136 mEq/L (i.e., below the normal range) at the time of screening.

6. Significant abnormal findings on physical examination.

7. Women who are pregnant or breastfeeding.

8. In the judgment of the investigators, the individual would be considered a poor candidate.