Back to resultsEffective Treatment for Prescription Opioid Abuse
Primary Purpose
Prescription Opioid Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
buprenorphine taper followed by naltrexone maintenance
Behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prescription Opioid Dependence focused on measuring prescription opioid, opioid detoxification, buprenorphine, naltrexone, community reinforcement approach, prescription opioid abuse
Eligibility Criteria
Inclusion Criteria:
- For inclusion in the proposed studies, subjects must be > 18 years old and in good health. Subjects must meet DSM-IV criteria for opioid dependence and FDA qualification criteria for buprenorphine treatment, including a history of opioid dependence and significant current opioid use (i.e., opioid-positive urines). Subjects must also be seeking or willing to accept opioid detoxification.
Exclusion Criteria:
- Because the primary focus of the proposed research is to develop an efficacious intervention for prescription opioid abuse that employs a buprenorphine taper and subsequent naltrexone maintenance, individuals who require ongoing opioid therapy for pain or other chronic medical conditions will be excluded from participating.
- Individuals with evidence of an active psychiatric disorder that may interfere with consent or participation in the research (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., cardiovascular disease) or who are pregnant or nursing will be excluded from participation.
Sites / Locations
- Substance Abuse Treatment Center, University of Vermont
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1-week buprenorphine taper
2-week buprenorphine taper
4-week buprenorphine taper
Arm Description
1-week buprenorphine taper + behavioral therapy + urine toxicology
2-week buprenorphine taper + behavioral therapy + urine toxicology
4-week buprenorphine taper + behavioral therapy + urine toxicology
Outcomes
Primary Outcome Measures
percentage of subjects abstinent from all opioids through the final day of detoxification
Secondary Outcome Measures
percentage of subjects retained in treatment through the final day of detoxification
Full Information
NCT ID
NCT00719095
First Posted
July 17, 2008
Last Updated
April 12, 2013
Sponsor
University of Vermont Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00719095
Brief Title
Effective Treatment for Prescription Opioid Abuse
Official Title
Effective Treatment for Prescription Opioid Abuse
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Vermont Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.
Detailed Description
There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance. Aim 1) Conduct a randomized, three-parallel-groups clinical trial (Study 1) to determine a buprenorphine dose-tapering schedule that prevents the poor retention and relapse that undermine many opioid detoxification regimens. Aim 2) Conduct a randomized, three-parallel-groups clinical trial (Study 2) to determine a duration of naltrexone therapy that sustains opioid abstinence following the buprenorphine detoxification.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prescription Opioid Dependence
Keywords
prescription opioid, opioid detoxification, buprenorphine, naltrexone, community reinforcement approach, prescription opioid abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1-week buprenorphine taper
Arm Type
Experimental
Arm Description
1-week buprenorphine taper + behavioral therapy + urine toxicology
Arm Title
2-week buprenorphine taper
Arm Type
Experimental
Arm Description
2-week buprenorphine taper + behavioral therapy + urine toxicology
Arm Title
4-week buprenorphine taper
Arm Type
Experimental
Arm Description
4-week buprenorphine taper + behavioral therapy + urine toxicology
Intervention Type
Drug
Intervention Name(s)
buprenorphine taper followed by naltrexone maintenance
Intervention Description
direct comparison of 1-, 2- and 4-week durations of buprenorphine taper for treating prescription opioid abusers; those who successfully taper without resumption of illicit opioid use are subsequently transitioned to oral naltrexone therapy for the remainder of the 12-week trial; all participants receive a platform of intensive individual behavioral therapy and on-site urinalysis monitoring throughout the trial
Intervention Type
Behavioral
Intervention Name(s)
Behavioral therapy
Primary Outcome Measure Information:
Title
percentage of subjects abstinent from all opioids through the final day of detoxification
Time Frame
up to 12-week trial
Secondary Outcome Measure Information:
Title
percentage of subjects retained in treatment through the final day of detoxification
Time Frame
up to 12-week trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
For inclusion in the proposed studies, subjects must be > 18 years old and in good health. Subjects must meet DSM-IV criteria for opioid dependence and FDA qualification criteria for buprenorphine treatment, including a history of opioid dependence and significant current opioid use (i.e., opioid-positive urines). Subjects must also be seeking or willing to accept opioid detoxification.
Exclusion Criteria:
Because the primary focus of the proposed research is to develop an efficacious intervention for prescription opioid abuse that employs a buprenorphine taper and subsequent naltrexone maintenance, individuals who require ongoing opioid therapy for pain or other chronic medical conditions will be excluded from participating.
Individuals with evidence of an active psychiatric disorder that may interfere with consent or participation in the research (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g., cardiovascular disease) or who are pregnant or nursing will be excluded from participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey C. Sigmon, Ph.D.
Organizational Affiliation
University of Vermont, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Abuse Treatment Center, University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24153411
Citation
Sigmon SC, Dunn KE, Saulsgiver K, Patrick ME, Badger GJ, Heil SH, Brooklyn JR, Higgins ST. A randomized, double-blind evaluation of buprenorphine taper duration in primary prescription opioid abusers. JAMA Psychiatry. 2013 Dec;70(12):1347-54. doi: 10.1001/jamapsychiatry.2013.2216.
Results Reference
derived
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Effective Treatment for Prescription Opioid Abuse
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