Extended Release Naltrexone for Opioid-Dependent Youth

Friends Research Institute

Status and phase: Completed; Phase 4

Conditions: Drug Dependence

Treatments: Behavioral: Psychosocial Treatment; Drug: Buprenorphine; Drug: Extended Release Naltrexone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01843023

1R01DA033391-01A1

R01DA033391 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 288 patients

Sex: All

Ages: 15 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

Extended Release Naltrexone

Experimental group

Description:

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:

Drug: Extended Release Naltrexone

Behavioral: Psychosocial Treatment

Treatment as Usual

Active Comparator group

Description:

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.

Treatment:

Drug: Buprenorphine

Behavioral: Psychosocial Treatment