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Effective Treatment for Prescription Opioid Abuse

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00719095
First Posted: July 21, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Vermont Medical Center
  Purpose
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.

Condition Intervention Phase
Prescription Opioid Dependence Drug: buprenorphine taper followed by naltrexone maintenance Behavioral: Behavioral therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effective Treatment for Prescription Opioid Abuse

Resource links provided by NLM:


Further study details as provided by University of Vermont Medical Center:

Primary Outcome Measures:
  • percentage of subjects abstinent from all opioids through the final day of detoxification [ Time Frame: up to 12-week trial ]

Secondary Outcome Measures:
  • percentage of subjects retained in treatment through the final day of detoxification [ Time Frame: up to 12-week trial ]

Enrollment: 105
Study Start Date: April 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1-week buprenorphine taper
1-week buprenorphine taper + behavioral therapy + urine toxicology
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: 2-week buprenorphine taper
2-week buprenorphine taper + behavioral therapy + urine toxicology
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: 4-week buprenorphine taper
4-week buprenorphine taper + behavioral therapy + urine toxicology
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719095


Locations
United States, Vermont
Substance Abuse Treatment Center, University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Stacey C. Sigmon, Ph.D. University of Vermont, Department of Psychiatry
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stacey C. Sigmon, Ph.D., University of Vermont
ClinicalTrials.gov Identifier: NCT00719095     History of Changes
Other Study ID Numbers: R01DA019989 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2008
First Posted: July 21, 2008
Last Update Posted: October 12, 2017
Last Verified: July 2008

Keywords provided by University of Vermont Medical Center:
prescription opioid
opioid detoxification
buprenorphine
naltrexone
community reinforcement approach
prescription opioid abuse

Additional relevant MeSH terms:
Analgesics, Opioid
Buprenorphine
Naltrexone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists