Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1

This study has been completed.

First Received: September 20, 1999 Last Updated: November 3, 2005 History of Changes

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	University of Colorado at Denver and Health Sciences Center
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000326

Purpose

The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.

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

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)

Resource links provided by NLM:

MedlinePlus related topics: Heroin

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naloxone hydrochloride Naloxone

U.S. FDA Resources

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

Primary Outcome Measures:

Drug use
Retention
Subjective dose estimate
Observed withdrawal rating
Opioid agonist rating
Opioid antagonist rating
Pupil diameter
Compliance
Analog rating scale for drug effects
Drug effect characteristics
Dose order estimate-nurse
Dose order estimate-client

Estimated Enrollment:	0
Study Start Date:	April 1997

Detailed Description:

Alternate-day dosing with the 8mg buprenorhpine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided druing alternate-day dosing is equal to that given during daily dosing.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Individuals must be currently opioid 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: NCT00000326

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:

(presented at ACNP 1997. Kamien, J.B., Mikulich, S.K., and Amass, L., Efficacy of the buprenorphine/naloxone tablet for daily vs. alternate-day opioid dependence treatment. Presented to the 1998 Meeting of the College on Problems of Drug Dependence.. Presented at ACNP 1997 and CPDD 1998.

Study ID Numbers:	NIDA-11160-1, R01-11160-1
Study First Received:	September 20, 1999
Last Updated:	November 3, 2005
ClinicalTrials.gov Identifier:	NCT00000326 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Heroin Dependence
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Naloxone

Buprenorphine
Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009