Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents
Primary Purpose
Opiate Addiction
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Naltrexone
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Addiction focused on measuring drug dependence, substance abuse, substance use disorders, buprenorphine, naltrexone, adolescents
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
Sites / Locations
- UB Department of Family Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
buprenophine/naloxone
Naltrexone
Arm Description
Participants with this arm will receive 4-16 mg/d buprenorphine/naloxone (Suboxone).
Participants assigned to this arm will receive 50 mg/d naltrexone.
Outcomes
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.
Secondary Outcome Measures
Opioid craving: (1-10) as measured by a 10 point visual analog scale.
Self-reported drug use: (days to first use and percent days abstinent) as measured by time line follow back.
Urine toxicology: (yes/no) at baseline and monthly at 1, 2, 3, 4, 5, 6 months follow-up.
Full Information
NCT ID
NCT01015066
First Posted
October 15, 2009
Last Updated
June 6, 2014
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT01015066
Brief Title
Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents
Official Title
A Randomized Controlled Trial Comparing Buprenorphine/Naloxone With Naltrexone for Treatment in Opioid Dependent Adolescents and Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Study personnel left institution, anticipated funding did not occur
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction
Keywords
drug dependence, substance abuse, substance use disorders, buprenorphine, naltrexone, adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
buprenophine/naloxone
Arm Type
Active Comparator
Arm Description
Participants with this arm will receive 4-16 mg/d buprenorphine/naloxone (Suboxone).
Arm Title
Naltrexone
Arm Type
Experimental
Arm Description
Participants assigned to this arm will receive 50 mg/d naltrexone.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Other Intervention Name(s)
Suboxone
Intervention Description
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
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
ReVia
Intervention Description
Oral tables, 50 mg/d, once a day for six months
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Opioid craving: (1-10) as measured by a 10 point visual analog scale.
Time Frame
6 months
Title
Self-reported drug use: (days to first use and percent days abstinent) as measured by time line follow back.
Time Frame
6 months
Title
Urine toxicology: (yes/no) at baseline and monthly at 1, 2, 3, 4, 5, 6 months follow-up.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Blondell, MD
Organizational Affiliation
SUNY Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
UB Department of Family Medicine
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents
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