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

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: NCT00000326
Recruitment Status : Withdrawn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 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 or disease Intervention/treatment Phase
Heroin Dependence Opioid-Related Disorders Drug: Heroin Dependence Phase 2

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

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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 1(1)
Study Start Date : April 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. Subjective dose estimate
  4. Observed withdrawal rating
  5. Opioid agonist rating
  6. Opioid antagonist rating
  7. Pupil diameter
  8. Compliance
  9. Analog rating scale for drug effects
  10. Drug effect characteristics
  11. Dose order estimate-nurse
  12. Dose order estimate-client

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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): NCT00000326

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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
(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.

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Responsible Party: University of Colorado, Denver Identifier: NCT00000326    
Other Study ID Numbers: NIDA-11160-1
1R01DA011160 ( 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:
Heroin Dependence
Additional relevant MeSH terms:
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Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents