NCT00000331

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
3.2 years until next milestone

Study Start

First participant enrolled

December 1, 2002

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

Same day

First QC Date

September 20, 1999

Last Update Submit

May 2, 2017

Conditions

Heroin DependenceOpioid-Related Disorders

Keywords

Heroin Dependence

Outcome Measures

Primary Outcomes (3)

  • Observed withdrawal rating

  • Pupil diameter

  • Drug effect characteristics

Study Arms (2)

Test Drug

EXPERIMENTAL

Test drug to prevent heroine withdrawal

Drug: Test Drug

Placebo Pill

PLACEBO COMPARATOR

Placebo drug

Drug: Placebo Drug

Interventions

Test DrugDRUG
Also known as: test drug o
Test Drug
Placebo DrugDRUG
Placebo Pill

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health Sciences Center

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Heroin DependenceOpioid-Related Disorders

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Leslie Amass, Ph.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

December 1, 2002

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

May 4, 2017

Record last verified: 2017-05

Locations

US(1)