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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Colorado at Denver and Health Sciences Center |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00000326 |
Purpose
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 | Intervention | Phase |
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Heroin Dependence Opioid-Related Disorders |
Drug: Heroin Dependence |
Phase II |
| MedlinePlus related topics: | Heroin |
| Drug Information available for: | Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride Diacetylmorphine Diacetylmorphine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Placebo Control, Crossover Assignment |
| Official Title: | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1) |
| Estimated Enrollment: | 0 |
| Study Start Date: | April 1997 |
Alternate-day dosing with the 8mg buprenorhpine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided druing alternate-day dosing is equal to that given during daily dosing.
Eligibility
| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| 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 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| United States, Colorado | |||||
| University of Colorado Health Sciences Center | |||||
| Denver, Colorado, United States, 80206 | |||||
| National Institute on Drug Abuse (NIDA) |
| University of Colorado at Denver and Health Sciences Center |
| Principal Investigator: | Leslie Amass, Ph.D. | University of Colorado at Denver and Health Sciences Center |
More Information
|
(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.
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| Study ID Numbers: | NIDA-11160-1, R01-11160-1 |
| First Received: | September 20, 1999 |
| Last Updated: | November 3, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000326 |
| Health Authority: | United States: Federal Government |
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