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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00000330
Other study ID # NIDA-11160-5
Secondary ID R01DA011160R01-1
Status Withdrawn
Phase Phase 2
First received September 20, 1999
Last updated May 2, 2017
Start date October 1999
Est. completion date November 1999

Study information

Verified date May 2017
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the abuse liability and reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in heroin-dependent volunteers


Description:

not available at this time


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 1999
Est. primary completion date November 1999
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

Individuals must be at least 18 yrs of age, currently opioid dependent and must not be seeking 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 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Opioid-Related Disorders


Locations

Country Name City State
United States University of Colorado Health Sciences Center Denver Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective dose estimate
Primary Observed withdrawal rating
Primary Opioid antagonist rating
Primary Pupil diameter
Primary Analog rating scale for drug effects
Primary Drug effect characteristics
Primary Drug/Money Preferences
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