Extended Release Naltrexone for Opioid-Dependent Youth

Friends Research Institute, Inc.288 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

288

Conditions

Drug Dependence

Interventions

Extended Release NaltrexoneDRUG

naltrexone for extended release injectable suspension

Psychosocial TreatmentBEHAVIORAL

Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.

BuprenorphineDRUG

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.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (2)

Friends Research Institute

Baltimore, Maryland, United States

Mountain Manor Treatment Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: 6 months

Data from ClinicalTrials.gov

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