Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00000327
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 0
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.

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

Detailed Description

Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tablet (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic

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 I(2)
• Study Start Date: Jun 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. Compliance []

4. Dosing schedule preferences []

5. Analog rating scale for dosing schedule effects []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 62 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Individual must be currently 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

• Amass, L., Kamien, J.H., and Mikulich, S.K. Efficacy of and preference for 3-day vs daily dosing with the buprenorphine-naloxone combination tablet. presented to the 1998 Meeting of the College on Problems of Drug Dependence. Scottsdate, AZ (6/13-18). Presenting at CPDD 1998

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00000327
• Other Study ID Numbers: NIDA-11160-2; R01DA011160; R01-11160-2
• First Posted: Sep 21, 1999
• Last Update Posted: May 4, 2017
• Last Verified: May 1, 2017

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

Study Results

No Results Posted as of May 4, 2017