Extended Release Naltrexone for Opioid-Dependent Youth

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Friends Research Institute, Inc.
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics, Opioid; Buprenorphine; Naltrexone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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