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

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. Identifier: NCT00000327
Recruitment Status : Withdrawn
First Posted : September 21, 1999
Last Update Posted : May 4, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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 or disease Intervention/treatment Phase
Heroin Dependence Opioid-Related Disorders Drug: Heroin Dependence Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2)
Study Start Date : June 1997
Actual Primary Completion Date : August 1997
Actual Study Completion Date : August 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

Primary Outcome Measures :
  1. Drug use
  2. Retention
  3. Compliance
  4. Dosing schedule preferences
  5. Analog rating scale for dosing schedule effects

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

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.

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 identifier (NCT number): NCT00000327

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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)
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Principal Investigator: Leslie Amass, Ph.D. University of Colorado, Denver

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

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Responsible Party: University of Colorado, Denver Identifier: NCT00000327     History of Changes
Other Study ID Numbers: NIDA-11160-2
R01DA011160 ( U.S. NIH Grant/Contract )
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Keywords provided by University of Colorado, Denver:
drug dependence
Additional relevant MeSH terms:
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Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists