Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents

NCT ID: NCT01015066

Last Updated: 2014-06-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2014-06-30

Brief Summary

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.

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).

Conditions

Opiate Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

buprenophine/naloxone

Participants with this arm will receive 4-16 mg/d buprenorphine/naloxone (Suboxone).

Group Type: ACTIVE_COMPARATOR

Buprenorphine/naloxone

Intervention Type: DRUG

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)

Naltrexone

Participants assigned to this arm will receive 50 mg/d naltrexone.

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

Oral tables, 50 mg/d, once a day for six months

Interventions

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)

Intervention Type: DRUG

Naltrexone

Oral tables, 50 mg/d, once a day for six months

Intervention Type: DRUG

Other Intervention Names

Suboxone; ReVia

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Richard Blondell

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard D Blondell, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Buffalo

Locations

UB Department of Family Medicine

Buffalo, New York, United States

Countries

United States

Other Identifiers

FMD04405009B

Identifier Type: -

Identifier Source: org_study_id