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Sponsored by: |
Medical University of South Carolina |
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Information provided by: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00751023 |
Methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. Relapse rates are high in this population. Exposure to cues previously associated with methamphetamine use may induce profound craving in abstinent individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits that may undermine successful participation in psychosocial treatments.
Medications which improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence rates, especially in the critical early period of recovery. Modafinil is an atypical stimulant medication with evidence to support its use in treating cocaine dependence and attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.
Condition | Intervention | Phase |
---|---|---|
Methamphetamine Dependence |
Drug: Modafinil Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of Modafinil in Methamphetamine Dependence |
Estimated Enrollment: | 60 |
Study Start Date: | February 2009 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Modafinil 400 mg daily
|
Drug: Modafinil
400 mg daily for four weeks
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo 2 tablets daily for 4 weeks
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bryan K Tolliver, MD, PhD | (843) 792-4869 | tollive@musc.edu |
Contact: Kimber Price, PhD | (843) 792-5205 |
Investigator: | Bryan K Tolliver, MD, PhD |
Responsible Party: | MUSC Department of Psychiatry, Division of Clinical Neuroscience ( Bryan K. Tolliver, M.D., Ph.D. ) |
Study ID Numbers: | HR#18440 |
Study First Received: | September 10, 2008 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00751023 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Methamphetamine Modafinil Addiction Craving Cognitive |
Dopamine Uptake Inhibitors Neurotransmitter Agents Methamphetamine Behavior, Addictive 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 |