Extended Release Naltrexone for Opioid-Dependent Youth

Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth

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).

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 community drug treatment program in Baltimore. TAU will consist of buprenorphine treatment of opioid withdrawal followed by counseling with or without continued buprenorphine.

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