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Effective Treatment for Prescription Opioid Abuse

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fletcher Allen Health Care
ClinicalTrials.gov Identifier:
NCT00719095
First received: July 17, 2008
Last updated: April 12, 2013
Last verified: July 2008

July 17, 2008
April 12, 2013
April 2006
March 2010   (final data collection date for primary outcome measure)
percentage of subjects abstinent from all opioids through the final day of detoxification [ Time Frame: up to 12-week trial ] [ Designated as safety issue: No ]
percentage of subjects abstinent from all opioids through the final day of detoxification [ Time Frame: continuously and at end of 12-week trial ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00719095 on ClinicalTrials.gov Archive Site
percentage of subjects retained in treatment through the final day of detoxification [ Time Frame: up to 12-week trial ] [ Designated as safety issue: No ]
percentage of subjects retained in treatment through the final day of detoxification [ Time Frame: continuously and at end of 12-week trial ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effective Treatment for Prescription Opioid Abuse
Effective Treatment for Prescription Opioid Abuse

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prescription Opioid Dependence
  • Drug: buprenorphine taper followed by naltrexone maintenance
    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
  • Behavioral: Behavioral therapy
  • Experimental: 1-week buprenorphine taper
    1-week buprenorphine taper + behavioral therapy + urine toxicology
    Interventions:
    • Drug: buprenorphine taper followed by naltrexone maintenance
    • Behavioral: Behavioral therapy
  • Experimental: 2-week buprenorphine taper
    2-week buprenorphine taper + behavioral therapy + urine toxicology
    Interventions:
    • Drug: buprenorphine taper followed by naltrexone maintenance
    • Behavioral: Behavioral therapy
  • Experimental: 4-week buprenorphine taper
    4-week buprenorphine taper + behavioral therapy + urine toxicology
    Interventions:
    • Drug: buprenorphine taper followed by naltrexone maintenance
    • Behavioral: Behavioral therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00719095
R01-DA019989, R01DA019989
No
Stacey C. Sigmon, Ph.D., University of Vermont
Fletcher Allen Health Care
National Institute on Drug Abuse (NIDA)
Principal Investigator: Stacey C. Sigmon, Ph.D. University of Vermont, Department of Psychiatry
Fletcher Allen Health Care
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP