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

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00000329
• Other study ID #: NIDA-11160-4
• Secondary ID: R01DA011160R01-1
• Status: Withdrawn
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: May 2, 2017
• Start date: April 1999
• Est. completion date: August 1999

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 buprenorphine-naloxone maintained volunteers

Description:

Ongoing study - results not available at this time

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1999
• Est. primary completion date: August 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heroin Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Opioid-Related Disorders

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	Subjective dose estimate
Primary	Observed withdrawal rating
Primary	Opioid agonist rating
Primary	Opioid antagonist rating
Primary	Pupil diameter
Primary	Analog rating scale for drug effects
Primary	Drug effect characteristics
Primary	Drug/Money Preferences