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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: | NCT00000328 |
The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.
Condition | Intervention | Phase |
Heroin Dependence Opioid-Related Disorders |
Drug: Opioid-Related Disorders |
Phase II |
MedlinePlus related topics: | Heroin |
Drug Information available for: | Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Individuals must be at least 18 years of age, currently opioid dependent and meet FDA critera 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 |
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 |
Study ID Numbers: | NIDA-11160-3, R01-11160-3 |
First Received: | September 20, 1999 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00000328 |
Health Authority: | United States: Federal Government |
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