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Sponsored by: |
Medical University of South Carolina |
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 |
MedlinePlus related topics: | Methamphetamine |
ChemIDplus related topics: | Modafinil Methamphetamine |
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 |
Arms | Assigned Interventions |
1: Experimental
Modafinil 400 mg daily
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Drug: Modafinil
400 mg daily for four weeks
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo 2 tablets daily for 4 weeks
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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 |
Medical University of South Carolina |
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 |
First Received: | September 10, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00751023 |
Health Authority: | United States: Food and Drug Administration |
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