Effective Treatment for Prescription Opioid Abuse - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00719095

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; platform of behavioral therapy and urine toxicology testing throughout trial	Phase II

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Effective Treatment for Prescription Opioid Abuse

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	210
Study Start Date:	April 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1-week buprenorphine taper: Experimental 1-week buprenorphine taper + behavioral therapy + urine toxicology	Drug: buprenorphine taper followed by naltrexone maintenance; platform of behavioral therapy and urine toxicology testing throughout trial 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
2-week buprenorphine taper: Experimental 2-week buprenorphine taper + behavioral therapy + urine toxicology	Drug: buprenorphine taper followed by naltrexone maintenance; platform of behavioral therapy and urine toxicology testing throughout trial 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
4-week buprenorphine taper: Experimental 4-week buprenorphine taper + behavioral therapy + urine toxicology	Drug: buprenorphine taper followed by naltrexone maintenance; platform of behavioral therapy and urine toxicology testing throughout trial 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

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

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

Locations

United States, Vermont
Substance Abuse Treatment Center, University of Vermont	Recruiting
Burlington, Vermont, United States, 05401
Contact: Stacey C. Sigmon, Ph.D. 802-656-9987 stacey.sigmon@uvm.edu
Principal Investigator: Stacey C. Sigmon, Ph.D.

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Stacey C. Sigmon, Ph.D.

University of Vermont, Department of Psychiatry

More Information

Responsible Party:	University of Vermont ( Stacey C. Sigmon, Ph.D. )
Study ID Numbers:	R01-DA019989, R01-DA019989
Study First Received:	July 17, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00719095
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by National Institute on Drug Abuse (NIDA):

prescription opioid
opioid detoxification
buprenorphine

naltrexone
community reinforcement approach
prescription opioid abuse

Study placed in the following topic categories:

Buprenorphine
Naltrexone

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 13, 2009