Extended Release Naltrexone for Opioid-Dependent Youth

NCT01843023 | Completed Phase 4 Results DMC

• 2 other identifiers: 1R01DA033391-01A1R01DA033391
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 2

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).

Conditions

Drug Dependence

Keywords

opioid dependence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Treatment Retention

  6 months

• Monetized Healthcare Utilization

  6 months

• HIV Sex Risk Behaviors

  6 months

Study Arms (2)

Extended Release Naltrexone

EXPERIMENTAL

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; Behavioral: Psychosocial Treatment

Treatment as Usual

ACTIVE COMPARATOR

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; Drug: Buprenorphine

Interventions

Extended Release Naltrexone DRUG

naltrexone for extended release injectable suspension

Also known as: Vivitrol

Extended Release Naltrexone

Psychosocial Treatment BEHAVIORAL

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

Extended Release Naltrexone; Treatment as Usual

Buprenorphine DRUG

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.

Also known as: Suboxone, Subutex

Treatment as Usual

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Friends Research Institute

Baltimore, Maryland, 21201, United States

Location

Mountain Manor Treatment Center

Baltimore, Maryland, 21229, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders

Interventions

vivitrol; Buprenorphine; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

There was poor participant adherence to receiving the randomly assigned condition prior to inpatient discharge. For this reason, great caution is urged in interpreting outcomes based on study condition as assigned.

Results Point of Contact

• Title: Dr. Shannon Gwin Mitchell
• Organization: Friends Research Institute

smitchell@friendsresearch.org

410-837-3977

Study Officials

• Shannon G Mitchell, PhD

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: April 30, 2013
• Study Start: June 1, 2013
• Primary Completion: January 31, 2018
• Study Completion: July 1, 2019
• Last Updated: November 10, 2021
• Results First Posted: November 10, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)