Back to resultsExtended Release Naltrexone for Opioid-Dependent Youth
Primary Purpose
Drug Dependence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Extended Release Naltrexone
Psychosocial Treatment
Buprenorphine
Sponsored by
About this trial
This is an interventional treatment trial for Drug Dependence focused on measuring opioid dependence
Eligibility Criteria
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
Sites / Locations
- Friends Research Institute
- Mountain Manor Treatment Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Extended Release Naltrexone
Treatment as Usual
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT01843023
First Posted
April 25, 2013
Last Updated
October 13, 2021
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01843023
Brief Title
Extended Release Naltrexone for Opioid-Dependent Youth
Official Title
Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Dependence
Keywords
opioid dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
288 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extended Release Naltrexone
Arm Type
Experimental
Arm 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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Extended Release Naltrexone
Other Intervention Name(s)
Vivitrol
Intervention Description
naltrexone for extended release injectable suspension
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Treatment
Intervention Description
Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
Suboxone, Subutex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid Use at 6 Month Follow-up
Description
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 Outcome Measure Information:
Title
Treatment Retention
Description
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
Title
Monetized Healthcare Utilization
Description
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
Title
HIV Sex Risk Behaviors
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon G Mitchell, PhD
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Mountain Manor Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extended Release Naltrexone for Opioid-Dependent Youth
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