Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
288 participants
INTERVENTIONAL
2013-06-30
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Extended Release Naltrexone
naltrexone for extended release injectable suspension
Psychosocial Treatment
Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
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.
Psychosocial Treatment
Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
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.
Interventions
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Extended Release Naltrexone
naltrexone for extended release injectable suspension
Psychosocial Treatment
Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
21 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Friends Research Institute, Inc.
OTHER
Responsible Party
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Principal Investigators
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Shannon G Mitchell, PhD
Role: PRINCIPAL_INVESTIGATOR
Friends Research Institute, Inc.
Locations
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Friends Research Institute
Baltimore, Maryland, United States
Mountain Manor Treatment Center
Baltimore, Maryland, United States
Countries
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Provided Documents
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