Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2 - 5

Phase 2

Withdrawn

• Conditions: Opioid-Related Disorders; Heroin Dependence

• Registration Number: NCT00000330
• Lead Sponsor: University of Colorado, Denver

Brief 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

Detailed Description

not available at this time

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 1999-09-20
• Study First Submitted QC: 1999-09-20
• Study First Posted: 1999-09-21
• Study Start: 1999-10
• Primary Completion: 1999-11
• Study Completion: 1999-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Observed withdrawal rating
Opioid antagonist rating
Drug effect characteristics
Drug/Money Preferences
Subjective dose estimate
Analog rating scale for drug effects
Pupil diameter

Trial Locations

Locations (1)

University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States