Home
Search
Study Topics
Glossary
|
|
|
|
|
|
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 |
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 |
---|---|---|
Heroin Dependence Opioid-Related Disorders |
Drug: Heroin Dependence |
Phase II |
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.
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.
United States, Colorado | |
University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80206 |
Principal Investigator: | Leslie Amass, Ph.D. | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | NIDA-11160-1, R01-11160-1 |
Study First Received: | September 20, 1999 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00000326 |
Health Authority: | United States: Federal Government |
Buprenorphine Heroin Mental Disorders Heroin Dependence |
Substance-Related Disorders Disorders of Environmental Origin Opioid-Related Disorders Naloxone |
Sensory System Agents Therapeutic Uses Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |