Extended Release Naltrexone for Opioid-Dependent Youth
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|ClinicalTrials.gov Identifier: NCT01843023|
Recruitment Status : Active, not recruiting
First Posted : April 30, 2013
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Drug Dependence||Drug: Extended Release Naltrexone Behavioral: Psychosocial Treatment Drug: Buprenorphine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||January 31, 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Extended Release Naltrexone
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
naltrexone for extended release injectable suspension
Other Name: VivitrolBehavioral: Psychosocial Treatment
Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
Active Comparator: Treatment as Usual
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
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.
- Opioid use at 6 month follow-up [ Time Frame: 6 months ]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.
- Treatment retention [ Time Frame: 6 months ]To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of days in treatment.
- Monetized Economic Form 90 scores as a function of treatment costs [ Time Frame: 6 months ]The cost-effectiveness will be assessed using the Economic Form 90 to collect data on economic outcomes of health utilization, crime, and employment/school enrollment status at each assessment point.
- HIV sex risk behaviors [ Time Frame: 6 months ]To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843023
|United States, Maryland|
|Friends Research Institute|
|Baltimore, Maryland, United States, 21201|
|Mountain Manor Treatment Center|
|Baltimore, Maryland, United States, 21229|
|Principal Investigator:||Shannon G Mitchell, PhD||Friends Research Institute, Inc.|