Extended Release Naltrexone for Opioid-Dependent Youth

Phase 4

Completed

Conditions: Drug Dependence

Interventions: Drug: Extended Release Naltrexone
Behavioral: Psychosocial Treatment
Drug: Buprenorphine

Registration Number: NCT01843023

Lead Sponsor: Friends Research Institute, Inc.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 288

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended Release Naltrexone	Extended Release Naltrexone	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.
Treatment as Usual	Psychosocial Treatment	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.
Extended Release Naltrexone	Psychosocial Treatment	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.
Treatment as Usual	Buprenorphine	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.

Primary Outcome Measures

Name	Time	Method
Opioid Use at 6 Month Follow-up	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Treatment Retention	6 months	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.
Monetized Healthcare Utilization	6 months	The cost-effectiveness will be assessed using the Economic Form 90 to collect data on economic outcomes of health utilization at 6 months.
HIV Sex Risk Behaviors	6 months	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).

Trial Locations

Locations (2): Friends Research Institute
🇺🇸
Baltimore, Maryland, United States
Mountain Manor Treatment Center
🇺🇸
Baltimore, Maryland, United States