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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3 - 6

Sponsor
University of Colorado, Denver (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00000331
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
0
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in healthy, non-drug dependent volunteers.

Condition or Disease Intervention/Treatment Phase
  • Drug: Test Drug
  • Drug: Placebo Drug
 Phase 2

Detailed Description

not available at this time

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3
Study Start Date :
Dec 1, 2002
Actual Primary Completion Date :
Dec 1, 2002
Actual Study Completion Date :
Dec 1, 2002

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test Drug

Test drug to prevent heroine withdrawal

Drug: Test Drug
Other Names:
  • test drug o

    		•
    Placebo Comparator: Placebo Pill

    Placebo drug

    Drug: Placebo Drug

    Outcome Measures

    Primary Outcome Measures

    1. Observed withdrawal rating []

    2. Pupil diameter []

    3. Drug effect characteristics []

    Eligibility Criteria

    Criteria

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

    Individuals must be healthy, non-drug dependent volunteers, be at least 18 years of age, and have no prior history of drug or alcohol abuse or dependence. Subjects must have had some minimal experience with opioids (e.g. at least two prior exposures)

    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT00000331
    Other Study ID Numbers:
    • NIDA-11160-6
    • R01DA011160
    • R01-11160-6
    First Posted:
    Sep 21, 1999
    Last Update Posted:
    May 4, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by University of Colorado, Denver
    Heroin Dependence
    Additional relevant MeSH terms:
    Opioid-Related Disorders
    Heroin Dependence

    Study Results

    No Results Posted as of May 4, 2017