Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2

This study has been completed.

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) University of Colorado at Denver and Health Sciences Center
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000327

Purpose

The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.

Condition	Intervention	Phase
Heroin Dependence Opioid-Related Disorders	Drug: Heroin Dependence	Phase II

MedlinePlus related topics: Heroin

Drug Information available for: Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Crossover Assignment
Official Title:	Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2)

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

Primary Outcome Measures:

Drug use
Retention
Compliance
Dosing schedule preferences
Analog rating scale for dosing schedule effects

Estimated Enrollment:	0
Study Start Date:	June 1997

Detailed Description:

Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tabelt (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic

Eligibility

Ages Eligible for Study:	18 Years to 62 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Individual must be currently dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.

Exclusion Criteria:

Individuals with evidence of an active DSM-IV Axis I psychiatric disorder (e.g., psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000327

Locations

United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80206

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Colorado at Denver and Health Sciences Center

Investigators

Principal Investigator:

Leslie Amass, Ph.D.

University of Colorado at Denver and Health Sciences Center

More Information

Publications:

Amass, L., Kamien, J.H., and Mikulich, S.K. Efficacy of and preference for 3-day vs daily dosing with the buprenorphine-naloxone combination tablet. presented to the 1998 Meeting of the College on Problems of Drug Dependence. Scottsdate, AZ (6/13-18). Presenting at CPDD 1998

Study ID Numbers:	NIDA-11160-2, R01-11160-2
Study First Received:	September 20, 1999
Last Updated:	November 3, 2005
ClinicalTrials.gov Identifier:	NCT00000327
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Buprenorphine
Heroin
Mental Disorders
Heroin Dependence

Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders
Naloxone

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 15, 2009