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

NCT ID: NCT00000329

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

1999-08-31

Brief Summary

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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

Detailed Description

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Ongoing study - results not available at this time

Conditions

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Heroin Dependence Opioid-Related Disorders

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Opioid-Related Disorders

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie Amass, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA011160

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-11160-4

Identifier Type: -

Identifier Source: secondary_id

NIDA-11160-4

Identifier Type: -

Identifier Source: org_study_id

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