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WithdrawnNCT00000331Updated May 4, 2017

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

A Phase 2 interventional study of Test Drug and Placebo Drug in Heroin Dependence and Opioid-Related Disorders, sponsored by University of Colorado, Denver. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

not available at this time

02

Conditions studied

  • Heroin Dependence
  • Opioid-Related Disorders

Keywords

  • Heroin Dependence
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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.

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
Double
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Test Drug

    Test drug to prevent heroine withdrawal

    Drug: Test Drug

  • Placebo comparator
    Placebo Pill

    Placebo drug

    Drug: Placebo Drug

Interventions

  • DrugTest Drug

    Also known as: test drug o

  • DrugPlacebo Drug
05

What researchers measure

Primary outcomes

  1. Observed withdrawal rating

  2. Pupil diameter

  3. Drug effect characteristics

06

Study locations

1 site
  • University of Colorado Health Sciences Center
    Denver, Colorado 80206, United States
07

Registry details

Key details

Study ID
NCT00000331
Lead sponsor
University of Colorado, Denver
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Sep 21, 1999
Start date
Dec 2002
Primary completion
Dec 2002
Completion
Dec 2002
Last update
May 4, 2017

Study contacts

Leslie Amass, Ph.D.
principal investigator · University of Colorado, Denver
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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