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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000329
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 assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in buprenorphine-naloxone maintained volunteers

Condition Intervention Phase
Heroin Dependence Opioid-Related Disorders Drug: Opioid-Related Disorders Phase 2

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Subjective dose estimate
  • Observed withdrawal rating
  • Opioid agonist rating
  • Opioid antagonist rating
  • Pupil diameter
  • Analog rating scale for drug effects
  • Drug effect characteristics
  • Drug/Money Preferences

Enrollment: 0
Study Start Date: April 1999
Study Completion Date: August 1999
Primary Completion Date: August 1999 (Final data collection date for primary outcome measure)
Detailed Description:
Ongoing study - results not available at this time
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Individuals must be at least 18 yrs of age, 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 and have a history of IV opioid use.

Exclusion Criteria:

Individuals with evidence of anti 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): NCT00000329


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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00000329     History of Changes
Other Study ID Numbers: NIDA-11160-4
R01DA011160 ( U.S. NIH Grant/Contract )
R01-11160-4
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
Analgesics, Opioid
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists