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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000327
First Posted: September 21, 1999
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Colorado, Denver
  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 2

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2)

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Drug use
  • Retention
  • Compliance
  • Dosing schedule preferences
  • Analog rating scale for dosing schedule effects

Enrollment: 0
Study Start Date: June 1997
Study Completion Date: August 1997
Primary Completion Date: August 1997 (Final data collection date for primary outcome measure)
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 tablet (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
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 Diagnostic and Statistical Manual of Mental Disorders (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000327


Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Leslie Amass, Ph.D. University of Colorado, Denver
  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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00000327     History of Changes
Other Study ID Numbers: NIDA-11160-2
R01DA011160 ( U.S. NIH Grant/Contract )
R01-11160-2
First Submitted: September 20, 1999
First Posted: September 21, 1999
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by University of Colorado, Denver:
drug dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists