Extended Release Naltrexone for Opioid-Dependent Youth

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Drug Dependence

Intervention / Treatment
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* Drug: Extended Release Naltrexone
* Behavioral: Psychosocial Treatment
* Drug: Buprenorphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Release Naltrexone<br>Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment. | Drug: Extended Release Naltrexone<br>* naltrexone for extended release injectable suspension<br>* Other names: Vivitrol;Behavioral: Psychosocial Treatment<br>* Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.<br>|
| Active Comparator: Treatment as Usual<br>Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment. | Behavioral: Psychosocial Treatment<br>* Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.<br>Drug: Buprenorphine<br>* Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.<br>* Other names: Subutex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use at 6 Month Follow-up | To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Retention | To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of days in treatment. Treatment defined as medications for OUD received in past 30 days at 6-month follow-up. | 6 months | 
| Monetized Healthcare Utilization | The cost-effectiveness will be assessed using the Economic Form 90 to collect data on economic outcomes of health utilization at 6 months. | 6 months | 
| HIV Sex Risk Behaviors | To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months. Past 90 days self-reported HIV sex risk behaviors on the Risk Assessment Battery (RAB). Minimum value 0; maximum value 24. Higher scores reflect endorsement of more risk behaviors (worse outcome). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid dependence