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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
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Friends Research Institute, Inc.

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).

Condition or disease Intervention/treatment Phase
Drug Dependence Drug: Extended Release Naltrexone Behavioral: Psychosocial Treatment Drug: Buprenorphine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth
Study Start Date : June 2013
Primary Completion Date : January 31, 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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: Vivitrol
Behavioral: 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.
Other Names:
  • Suboxone
  • Subutex

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. HIV sex risk behaviors [ Time Frame: 6 months ]
    To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months.

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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Friends Research Institute, Inc.
National Institute on Drug Abuse (NIDA)
Principal Investigator: Shannon G Mitchell, PhD Friends Research Institute, Inc.

Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01843023     History of Changes
Other Study ID Numbers: 1R01DA033391-01A1 ( U.S. NIH Grant/Contract )
R01DA033391 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Friends Research Institute, Inc.:
opioid dependence

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists