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

NCT ID: NCT00000331

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WITHDRAWN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

2002-12-31

Study Completion Date

2002-12-31

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 healthy, non-drug dependent volunteers.

Detailed Description

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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

Study Groups

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Test Drug

Test drug to prevent heroine withdrawal

Group Type EXPERIMENTAL

Test Drug

Intervention Type DRUG

Placebo Pill

Placebo drug

Group Type PLACEBO_COMPARATOR

Placebo Drug

Intervention Type DRUG

Interventions

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Test Drug

Intervention Type DRUG

Placebo Drug

Intervention Type DRUG

Other Intervention Names

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test drug o

Eligibility Criteria

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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.
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

R01-11160-6

Identifier Type: -

Identifier Source: secondary_id

NIDA-11160-6

Identifier Type: -

Identifier Source: org_study_id

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