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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effective Treatment for Prescription Opioid Abuse

Resource links provided by NLM:


Further study details as provided by Fletcher Allen Health Care:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • percentage of subjects retained in treatment through the final day of detoxification [ Time Frame: up to 12-week trial ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719095

Locations
United States, Vermont
Substance Abuse Treatment Center, University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Fletcher Allen Health Care
Investigators
Principal Investigator: Stacey C. Sigmon, Ph.D. University of Vermont, Department of Psychiatry
  More Information

No publications provided by Fletcher Allen Health Care

Additional 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: R01-DA019989, R01DA019989
Study First Received: July 17, 2008
Last Updated: April 12, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Fletcher Allen Health Care:
prescription opioid
opioid detoxification
buprenorphine
naltrexone
community reinforcement approach
prescription opioid abuse

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

ClinicalTrials.gov processed this record on November 25, 2014