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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00000326
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 0
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heroin Dependence; Opioid-Related Disorders	Drug: Heroin Dependence	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)
• Study Start Date: Apr 1, 1997
• Actual Primary Completion Date: Aug 1, 1997
• Actual Study Completion Date: Aug 1, 1997

Outcome Measures

Primary Outcome Measures

1. Drug use []

2. Retention []

3. Subjective dose estimate []

4. Observed withdrawal rating []

5. Opioid agonist rating []

6. Opioid antagonist rating []

7. Pupil diameter []

8. Compliance []

9. Analog rating scale for drug effects []

10. Drug effect characteristics []

11. Dose order estimate-nurse []

12. Dose order estimate-client []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Health Sciences Center	Denver	Colorado	United States	80206

Sponsors and Collaborators

• University of Colorado, Denver
• National Institute on Drug Abuse (NIDA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• (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.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00000326
• Other Study ID Numbers: NIDA-11160-1; 1R01DA011160; R01-11160-1
• First Posted: Sep 21, 1999
• Last Update Posted: May 4, 2017
• Last Verified: May 1, 2017

• Keywords provided by University of Colorado, Denver: Heroin Dependence
• Additional relevant MeSH terms: Opioid-Related Disorders; Heroin Dependence; Heroin

Study Results

No Results Posted as of May 4, 2017