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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2
This study has been completed.
Study NCT00000327   Information provided by National Institute on Drug Abuse (NIDA)
First Received: September 20, 1999   Last Updated: November 3, 2005   History of Changes

September 20, 1999
November 3, 2005
June 1997
 
  • Drug use
  • Retention
  • Compliance
  • Dosing schedule preferences
  • Analog rating scale for dosing schedule effects
Same as current
Complete list of historical versions of study NCT00000327 on ClinicalTrials.gov Archive Site
 
 
 
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2)

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.

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

Phase II
Interventional
Treatment, Double-Blind, Crossover Assignment
  • Heroin Dependence
  • Opioid-Related Disorders
Drug: Heroin Dependence
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
0
 
 

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.

Both
18 Years to 62 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000327
 
NIDA-11160-2, R01-11160-2
National Institute on Drug Abuse (NIDA)
University of Colorado at Denver and Health Sciences Center
Principal Investigator: Leslie Amass, Ph.D. University of Colorado at Denver and Health Sciences Center
National Institute on Drug Abuse (NIDA)
November 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP