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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00218127 |
Purpose
Heroin dependence remains a major addiction problem in the United States. The purpose of this study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin dependent individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Heroin Dependence Opioid-Related Disorders |
Drug: Levoacetyl Methadol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Opioid Maintenance: Optimum Stabilization and Withdrawal |
| Enrollment: | 142 |
| Study Start Date: | November 2001 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks
|
Drug: Levoacetyl Methadol
WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
|
|
2: Experimental
LAAM MaxEffect to 48 mg Adjust to effect (+/-)
|
Drug: Levoacetyl Methadol
MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
|
|
3: Experimental
LAAM Fixed Dose up to 48 mg 48 mg
|
Drug: Levoacetyl Methadol
LAAM Fixed Dose evaluation up to 48 mg 48 mg
|
Heroin is a highly addictive drug, and its abuse has both medical and social consequences. ORLAAM is approved to treat both opiate and narcotic dependence. The purpose of this study is to determine the efficacy of ORLAAM in treating heroin dependent individuals. In addition, this study will determine the most effective dosing regimen of ORLAAM.
This study will last 20 weeks. Participants will be randomly assigned to receive one of three dosing conditions:
1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use; doses may be adjusted throughout the study. All participants will receive cognitive behavioral therapy throughout the study.
Eligibility| Ages Eligible for Study: | 25 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Department of Psychatiry, Mental Services | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | John Grabowski, PhD | The University of Texas Health Science Center, Houston |
More Information
| Responsible Party: | University of Texas Medical School at Houston ( F. Gerard Moeller, M.D. ) |
| Study ID Numbers: | NIDA-13664-1, R01-13664-1, DPMC |
| Study First Received: | September 16, 2005 |
| Last Updated: | August 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00218127 History of Changes |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
Methadyl Acetate Heroin Mental Disorders Heroin Dependence Substance-Related Disorders Central Nervous System Depressants |
Disorders of Environmental Origin Narcotics Peripheral Nervous System Agents Analgesics Opioid-Related Disorders Analgesics, Opioid |
|
Heroin Dependence Physiological Effects of Drugs Central Nervous System Depressants Disorders of Environmental Origin Narcotics Opioid-Related Disorders Pharmacologic Actions Methadyl Acetate |
Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |
