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Extended Release Naltrexone for Opioid-Dependent Youth

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Friends Research Institute, Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shannon Gwin Mitchell, Ph.D., Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01843023
First received: April 25, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Drug Dependence
Drug: Extended Release Naltrexone
Behavioral: Psychosocial Treatment
Drug: Buprenorphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth

Resource links provided by NLM:


Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:
  • Opioid use at 6 month follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To examine the impact of XR-NTX on HIV sex-risk behaviors at 6 months.


Estimated Enrollment: 340
Study Start Date: June 2013
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01843023

Contacts
Contact: Shannon G Mitchell, PhD 410-837-3977 ext 238 smitchell@friendsresearch.org
Contact: Robert P Schwartz, MD 410-837-3977 ext 276 rschwartz@friendsresearch.org

Locations
United States, Maryland
Friends Research Institute Recruiting
Baltimore, Maryland, United States, 21201
Contact: Shannon G Mitchell, PhD    410-837-3977 ext 238    smitchell@friendsresearch.org   
Contact: Robert P Schwartz, MD    410-837-3977 ext 276    rschwartz@friendsresearch.org   
Mountain Manor Treatment Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Marc J Fishman, MD    410-233-1400    mjfishman@comcast.net   
Principal Investigator: Marc J Fishman, MD         
Sponsors and Collaborators
Friends Research Institute, Inc.
  More Information

No publications provided

Responsible Party: Shannon Gwin Mitchell, Ph.D., Senior Research Scientist, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01843023     History of Changes
Other Study ID Numbers: 1R01DA033391-01A1, R01DA033391
Study First Received: April 25, 2013
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Buprenorphine
Naltrexone
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014