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

Opioid-Related Disorders Clinical Trial

Official title:

Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00000326
• Other study ID #: NIDA-11160-1
• Secondary ID: 1R01DA011160R01-
• Status: Withdrawn
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: May 2, 2017
• Start date: April 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 assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.

Description:

Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.

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• Status: Withdrawn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 64 Years

Eligibility

Inclusion Criteria:

Individuals must be 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:
• Heroin Dependence

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, 

References & Publications (1)

(presented at ACNP 1997. Kamien, J.B., Mikulich, S.K., and Amass, L., Efficacy of the buprenorphine/naloxone tablet for daily vs. alternate-day opioid dependence treatment. Presented to the 1998 Meeting of the College on Problems of Drug Dependence.. Presented at ACNP 1997 and CPDD 1998.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug use
Primary	Retention
Primary	Subjective dose estimate
Primary	Observed withdrawal rating
Primary	Opioid agonist rating
Primary	Opioid antagonist rating
Primary	Pupil diameter
Primary	Compliance
Primary	Analog rating scale for drug effects
Primary	Drug effect characteristics
Primary	Dose order estimate-nurse
Primary	Dose order estimate-client