Extended Release Naltrexone for Opioid-Dependent Youth

Drug Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843023
• Other study ID #: 1R01DA033391-01A1
• Secondary ID: R01DA033391
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: July 2019

Study information

• Verified date: October 2021
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: July 2019
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Dependence
• Substance-Related Disorders

Intervention

Drug:
• Extended Release Naltrexone
naltrexone for extended release injectable suspension

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

Drug:
• Buprenorphine
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.

Locations

Country	Name	City	State
United States	Friends Research Institute	Baltimore	Maryland
United States	Mountain Manor Treatment Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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