Oxytocin Treatment of Opioid Dependence
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Opioid Dependence, Opioid Withdrawal
In brief
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.
Key facts
- Study ID
- NCT02548728
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 12
- Starts
- 2016-02-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2019-08-07
Who can join
Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 21-45.
- Regular opioid use (daily or nearly daily) for at least 6 months (subjective report).
- Active DSM-IV diagnosis of opioid dependence.
You may not qualify if…
- Meets DSM-IV criteria for dependence on psychoactive substances other than opioids, caffeine or nicotine within 6 months prior to screening.
- Treatment with naltrexone in the last month.
- 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.
- 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.
- Serum sodium < 136 mEq/L (i.e., below the normal range) at the time of screening.
- Significant abnormal findings on physical examination.
- Women who are pregnant or breastfeeding.
- In the judgment of the investigators, the individual would be considered a poor candidate.
Where it is running
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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