Not Signed In -
Heroin |
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Clinical Trial: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1
This study has been completed.
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 | Treatment or Intervention | Phase |
|---|---|---|
| Heroin Dependence Opioid-Related Disorders | Drug: Heroin Dependence | Phase II |
MedlinePlus related topics: Drug Abuse; Heroin Abuse
Study Type: Interventional
Study Design: Treatment, Double-Blind, Placebo Control, Crossover Assignment
Official Title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)
Study start: April 1997; Study completion: August 1997
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 - 64 Years, Genders Eligible for Study: Both
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.
Location Information
Colorado
University of Colorado Health Sciences Center, Denver, Colorado, 80206, United States
Leslie Amass, Ph.D., Principal Investigator, University of Colorado
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.
Record last reviewed: August 1997
Last Updated: February 16, 2005
Record first received: September 20, 1999
ClinicalTrials.gov Identifier: NCT00000326
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Heroin (Cleveland Clinic)
- Heroin: Abuse and Addiction (Cleveland Clinic)
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