Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3

Opioid-Related Disorders Clinical Trial

Official title:

Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00000328
• Other study ID #: NIDA-11160-3
• Secondary ID: 1R01DA011160R01-
• Status: Withdrawn
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: May 2, 2017
• Start date: July 1997
• Est. completion date: August 1997

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 compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.

Description:

S/A brief "Summary for the Public"

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1997
• Est. primary completion date: August 1997
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Individuals must be at least 18 years 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.

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:
• 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	Drug use
Primary	Retention
Primary	Opioid agonist rating
Primary	Opioid antagonist rating
Primary	Compliance
Primary	Medication identification
Primary	Addiction Severity Index (ASI) Composite Score Rating