Expired Study
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Denver, Colorado 80206


Purpose:

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.


Study summary:

not available at this time


Criteria:

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.


Study is Available At:


Original ID:

NIDA-11160-6


NCT ID:

NCT00000331


Secondary ID:

R01DA011160


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Leslie Amass, Ph.D.
Principal Investigator
University of Colorado, Denver

Study Dates

Start Date:December 2002
Completion Date:December 2002
Completion Type:Actual
Primary Completion Date:December 2002
Primary Completion Type:Actual
Verification Date:May 2017
Last Changed Date:May 2, 2017
First Received Date:September 20, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Drug effect characteristics
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pupil diameter
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Observed withdrawal rating
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Test Drug
Arm Name:Test Drug
Other Name:test drug o
Intervention Type:Drug
Name:Placebo Drug
Arm Name:Placebo Pill

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo Pill
Description:Placebo drug
Study Arm Type:Experimental
Arm Name:Test Drug
Description:Test drug to prevent heroine withdrawal

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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