Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents

June 6, 2014 updated by: Richard Blondell, State University of New York at Buffalo

A Randomized Controlled Trial Comparing Buprenorphine/Naloxone With Naltrexone for Treatment in Opioid Dependent Adolescents and Young Adults

This study is designed to determine the relative effectiveness of buprenorphine/naloxone (Suboxone) pharmacotherapy versus naltrexone pharmacotherapy for treatment retention, relapse prevention and opioid craving reduction among opioid-dependent adolescents and young adults. The investigators hypothesize that naltrexone treatment is as effective as buprenorphine/naloxone for these treatment outcomes.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Context: Standard treatment of opioid dependence in adolescents is detoxification and counseling, which results in relapse in 20-50% of patients. Alternative medical treatments include buprenorphine and naltrexone that have not been well investigated in adolescents and young adults. Buprenorphine has previously been shown effective in the treatment of opioid dependence in adolescents in one study in the United States as compared to detoxification. Although naltrexone treatment results in low compliance in adults, it is effective in combination with a strong social support network that exists in adolescents that live with at least 1 parent/guardian.

Objective: To compare the efficacy of buprenorphine/naloxone pharmacotherapy with naltrexone pharmacotherapy on treatment retention, relapse prevention and craving reduction among opioid-addicted adolescents and young adults.

Design: 2-arm Randomized Comparative Effectiveness Pharmacotherapy Clinical Trial.

Setting: The study will be conducted in an outpatient treatment facility Participants: The participants will be those who 1) are between 16-25 years old, 2) have clear evidence of a substance use disorder with opioid dependence, and 3) live with at least one parent.

Baseline data collection: Data collected at baseline will include (with examples), demographics (age, gender, race), substance use history (type of substances used, duration of use, routes of abuse), co-existing medical problems (seizures, hepatitis C), prior mental health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient, inpatient), socioeconomic variables (educational level, occupation, employment history), criminal history (number of arrests and convictions, total amount of time spent in jail or prison), family history (first degree relatives with substance use disorders) and scores on psychometric testing (DAST, opioid craving score).

Outcome data: Four main outcomes will be examined: Retention in treatment, self-reported opioid craving, self-reported drug use with urine toxicology confirmation. Retention in treatment (1-180 days) will be measured by the date that participant was last seen by study personnel or date when participant completes study following the date of enrollment. Opioid carving (1-10) will be measured by a 10 point visual analog scale. Self-reported drug use (days to first use and percent days abstinent) will be measured by time line follow back. Urine toxicology (yes/no) will be determined at baseline and monthly at 1, 2, 3, 4, 5, 6 months follow-up.

Data analysis: Outcome variables will be compared between the two groups using t-tests or chi-square tests as appropriate. A Kaplan-Myer survival analysis will be used to describe participant participation. Predictors of poor outcomes will be identified using a case-control design in which those with poor outcomes (the "cases") will be compared to those with successful outcomes (the "controls") using multivariate techniques (logistic regression).

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • UB Department of Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical Diagnosis of Opiate Dependence
  • Successful completion of detoxification
  • can answer 9 out of 10 question correctly that tests understanding of the study

Exclusion Criteria:

  • unable to pay for medication
  • not living with a parent/guardian
  • inability of patient and/or parent to give consent
  • major co-occurring psychiatric disorder
  • existing medical condition that would interfere with the treatment
  • use of CNS depressants
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: buprenophine/naloxone
Participants with this arm will receive 4-16 mg/d buprenorphine/naloxone (Suboxone).
Drug: Buprenorphine/naloxone
Sublingual tablets, 2/0.5mg (ratio buprenorphine:naloxone = 4:1), three times a day for six months (doses may be adjusted based on an individual's response)
Other Names:
  • Suboxone
Experimental: Naltrexone
Participants assigned to this arm will receive 50 mg/d naltrexone.
Drug: Naltrexone
Oral tables, 50 mg/d, once a day for six months
Other Names:
  • ReVia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retention in treatment: (1-180 days) as measured by the date that participant was last seen by study personnel or date when participant completes study following the date of enrollment.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Opioid craving: (1-10) as measured by a 10 point visual analog scale.
Time Frame: 6 months
6 months
Self-reported drug use: (days to first use and percent days abstinent) as measured by time line follow back.
Time Frame: 6 months
6 months
Urine toxicology: (yes/no) at baseline and monthly at 1, 2, 3, 4, 5, 6 months follow-up.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Investigators

  • Principal Investigator: Richard D Blondell, MD, SUNY Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 17, 2009

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 6, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMD04405009B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opiate Addiction

Clinical Trials on Buprenorphine/naloxone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe