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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00421603 |
Purpose
The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence. Since both of these medications have independently shown promise in helping with cocaine abuse we are proposing that together they may be even more successful in the treatment of cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients. This study includes free treatment for cocaine dependence that includes medication.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence |
Drug: Adderall-XR and Topiramate Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) and Topiramate for the Treatment of Cocaine Dependence |
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Adderall-XR and Topiramate
|
Drug: Adderall-XR and Topiramate
Adderall-XR 60mg/day and Topiramate 300mg/day
|
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo
|
Specific Aim 1: To determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients.
Primary Hypothesis: The proportion of participants achieving sustained cocaine abstinence (via urine toxicology) for three consecutive weeks during the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.
Hypothesis 2: The proportion of urine samples negative for cocaine metabolites will be greater in the combined pharmacotherapies group compared to the placebo group.
Hypothesis 3: The pattern of cocaine use (amount of cocaine used per day in dollars and the number of using days per week), as measured by the time-line follow-back method, will show a greater reduction in use for the combined pharmacotherapies group compared to the placebo group.
Specific Aim 2: To determine the effect of ER-MAS and topiramate on cocaine craving among cocaine-dependent patients.
Hypothesis 4: Cocaine craving symptoms will be reduced to a greater degree in the combined pharmacotherapies group compared to the placebo group.
Specific Aim 3: To explore a set of related secondary outcomes (treatment retention, global functioning, HIV risk behavior) as well as moderators and mediators potentially reflective of mechanism of action.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: daniel j brooks, M.A. | (212) 740-3205 | brooksd@pi.cpmc.columbia.edu |
| United States, New York | |
| STARS | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Daniel J Brooks, M.A. 212-740-3205 brooksd@pi.cpmc.columbia.edu | |
| Principal Investigator: Frances R Levin, M.D. | |
| Principal Investigator: | Frances R Levin, M.D. | Columbia University |
More Information
| Responsible Party: | Columbia University/NYSPI ( Frances R. Levin, M.D ) |
| Study ID Numbers: | R01 DA022217, R01 DA022217, DPMCDA |
| Study First Received: | January 10, 2007 |
| Last Updated: | October 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00421603 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Cocaine Adderall Topiramate ADHD |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adderall Adrenergic Uptake Inhibitors Physiological Effects of Drugs Anesthetics Disorders of Environmental Origin Neuroprotective Agents Sensory System Agents Mental Disorders Therapeutic Uses Substance-Related Disorders |
Vasoconstrictor Agents Topiramate Cocaine Cocaine-Related Disorders Sympathomimetics Central Nervous System Depressants Central Nervous System Stimulants Cardiovascular Agents Protective Agents Anesthetics, Local Pharmacologic Actions Anti-Obesity Agents Autonomic Agents Amphetamine Dopamine Agents |