Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Arkansas |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00859573 |
Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential facility to achieve initial abstinence and be inducted onto study medication during wks 1-2. Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly psychotherapy while continuing to receive study medications. Urine samples will be collected thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the results of this study will contribute to our understanding of which types of agents may be good candidates for further development as potential treatment agents for this disorder.
Condition | Intervention | Phase |
---|---|---|
Methamphetamine Dependence |
Drug: Modafinil Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Efficacy of Modafinil in Recently-Abstinent Methamphetamine-Dependent Volunteers |
Estimated Enrollment: | 50 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1. Modafinil: Active Comparator |
Drug: Modafinil
400 mg/day
|
2: Placebo: Placebo Comparator
Placebo
|
Drug: Placebo
inactive substance
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
18-65 years old. For the neurophysiological measures portion of the study subjects will be included if they are between the ages of 20-65 because the P50 potential is not fully developed in children and adolescents (Rasco 2000).
Exclusion Criteria:
Contact: Mahadev Prasad | 501-526-7969 | prasadmahadev@uams.edu |
Principal Investigator: | Michael Mancino, MD | University of Arkansas |
Responsible Party: | University of Arkansas for Medical Sciences ( Michael Mancino, MD/Assistant Professor ) |
Study ID Numbers: | P50 DA018197-104386, P50 DA018197 |
Study First Received: | March 10, 2009 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00859573 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dopamine Uptake Inhibitors Neurotransmitter Agents Methamphetamine Dopamine Adrenergic Agents Central Nervous System Stimulants |
Dopamine Agents Amphetamine Peripheral Nervous System Agents Neuroprotective Agents Modafinil |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Sympathomimetics Physiological Effects of Drugs Central Nervous System Stimulants Protective Agents |
Neuroprotective Agents Modafinil Pharmacologic Actions Methamphetamine Autonomic Agents Therapeutic Uses Amphetamine Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |