Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents

NCT01015066 | Withdrawn Phase 4 DMC

• 1 other identifier: FMD04405009B
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Addiction

Keywords

drug dependence; substance abuse; substance use disorders; buprenorphine; naltrexone; adolescents

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Opioid craving: (1-10) as measured by a 10 point visual analog scale.

  6 months

• Self-reported drug use: (days to first use and percent days abstinent) as measured by time line follow back.

  6 months

• Urine toxicology: (yes/no) at baseline and monthly at 1, 2, 3, 4, 5, 6 months follow-up.

  6 months

Study Arms (2)

buprenophine/naloxone

ACTIVE COMPARATOR

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

Drug: Buprenorphine/naloxone

Naltrexone

EXPERIMENTAL

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

Drug: Naltrexone

Interventions

Buprenorphine/naloxone 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)

Also known as: Suboxone

buprenophine/naloxone

Naltrexone DRUG

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

Also known as: ReVia

Naltrexone

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

UB Department of Family Medicine

Buffalo, New York, 14203, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination; Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Richard D Blondell, MD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: November 17, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 10, 2014

Record last verified: 2014-06

Locations

US (1)