Status:
COMPLETED
Extended Release Naltrexone for Opioid-Dependent Youth
Lead Sponsor:
Friends Research Institute, Inc.
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Drug Dependence
Eligibility:
All Genders
15-21 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).
Detailed Description
This proposed study is a 6-month, two-group randomized clinical trial of XR-NTX v. TAU for 340 opioid-dependent youth ages 15-21. The study will be conducted at Mountain Manor Treatment Center, a comm...
Eligibility Criteria
Inclusion
- Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence, physiologic subtype;
- Within 3 days of admission to MMTC;
- Age between 15 and 21, inclusive;
- Able and willing to provide informed consent to be randomly assigned to XR- NTX or TAU; and for participants under 18 years of age, parental or guardian consent and participant assent.
Exclusion
- Liver function test levels (Alanine Transaminase, Aspartate Transaminase) four times greater than normal;
- Unstable medical or psychiatric illness (e.g., schizophrenia) that might make participation hazardous;
- History of serious suicide attempt in the past 6 months;
- History of allergic reaction to naloxone, and/or naltrexone;
- Current chronic pain condition for which opioids are deemed necessary for ongoing care;
- blood coagulation disorder (e.g., hemophilia);
- Body Mass Index \> 40;
- If female, pregnant, lactating, unwilling or unable (due to parental objection) to use FDA-approved contraceptive methods;
- meeting DSM-IV criteria for benzodiazepine dependence
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT01843023
Start Date
June 1 2013
End Date
July 1 2019
Last Update
November 10 2021
Active Locations (2)
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1
Friends Research Institute
Baltimore, Maryland, United States, 21201
2
Mountain Manor Treatment Center
Baltimore, Maryland, United States, 21229