Extended Release Naltrexone for Opioid-Dependent Youth

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