Effective Treatment for Prescription Opioid Abuse - Full Text View

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:

Drug Information available for: Naltrexone Naltrexone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

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

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

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Stacey C. Sigmon, Ph.D.

University of Vermont, Department of Psychiatry

More Information

No publications provided

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:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naltrexone
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013