Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents

This study is currently recruiting participants.
Verified December 2012 by State University of New York at Buffalo
Sponsor:
Information provided by (Responsible Party):
Richard Blondell, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01015066
First received: October 15, 2009
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Opiate Addiction
Drug: Buprenorphine/naloxone
Drug: Naltrexone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Buprenorphine/Naloxone With Naltrexone for Treatment in Opioid Dependent Adolescents and Young Adults

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: ReVia

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).

  Eligibility

Ages Eligible for Study:   16 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015066

Contacts
Contact: Richard D Blondell, MD (716) 898-4971 blondell@buffalo.edu

Locations
United States, New York
Sheehan Memorial Hospital Recruiting
Buffalo, New York, United States, 14203
Principal Investigator: Richard D Blondell, MD         
UB Department of Family Medicine Not yet recruiting
Buffalo, New York, United States, 14125
Contact: Richard D Blondell, MD    716-898-4971    blondell@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: Richard D Blondell, MD SUNY Buffalo
  More Information

No publications provided

Responsible Party: Richard Blondell, MD, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01015066     History of Changes
Other Study ID Numbers: FMD04405009B
Study First Received: October 15, 2009
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
drug dependence
substance abuse
substance use disorders
buprenorphine
naltrexone
adolescents

Additional relevant MeSH terms:
Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naltrexone
Naloxone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on April 15, 2014