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

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00000331
• Other study ID #: NIDA-11160-6
• Secondary ID: R01DA011160R01-1
• Status: Withdrawn
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: May 2, 2017
• Start date: December 2002
• Est. completion date: December 2002

Study information

• Verified date: May 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

not available at this time

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heroin Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Test Drug

• Placebo Drug

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed withdrawal rating
Primary	Pupil diameter
Primary	Drug effect characteristics