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Sponsored by: |
Yale University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00571246 |
The objective of this study is to evaluate the efficacy of topiramate (250mg) or lamotrigine (250mg) versus placebo in reducing alcohol consumption and decreasing symptoms of PTSD in patients with comorbid AD and PTSD.
Condition | Intervention | Phase |
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Alcohol Dependence Post Traumatic Stress Disorder |
Drug: lamotrigine and topiramate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | The Use of Anticonvulsants for Treatment of Patients With Alcohol Dependence and Post Traumatic Stress Disorder |
Estimated Enrollment: | 90 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
There is a high rate of comorbidity with alcohol dependence (AD) and post traumatic stress disorder (PTSD). The rates of PTSD among individuals with AD are at least twice as high as those in the general population. In addition, alcohol dependence is the most common comorbid condition in men with PTSD. Despite this, little is known about how to best treat individuals with comorbid AD and PTSD. The use of anticonvulsants represents a novel approach to treatment that may target symptoms of both AD and PTSD. Both Topiramate and Lamotrigine act on the GABAergic and glutamatergic systems. Topiramate has GABAergic effects by robustly increasing brain GABA, and antiglutamatergic effects by inhibiting glutamate function that might antagonize alcohol's rewarding effects in AD and could contribute to the regulating of reexperiencing and arousal symptoms in PTSD. Lamotrigine is a glutamate-inhibiting anticonvulsant that has shown efficacy in some dually diagnosed patients with alcohol dependence, and in patients with PTSD. Neither topiramate nor lamotrigine have been used to treat patients with comorbid PTSD and AD. Methods: Ninety men and women with a current diagnosis of AD and PTSD will be enrolled in a 16-week trial. They will be assigned, in a double-blind fashion, to either topiramate, lamotrigine or placebo. Significance: This project will be the first to compare anticonvulsants (topiramate and lamotrigine) to placebo as effective treatments for reducing alcohol consumption and PTSD symptoms in patients with AD and PTSD.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elizabeth Ralevski, Ph.D. | 203-932-5711 ext 4282 | elizabeth.ralevski@yale.edu |
United States, Connecticut | |
VA Connecticut Healthcare System | |
West Haven, Connecticut, United States, 06516 |
Principal Investigator: | Ismene L Petrakis, MD | VA Connecticut Healthcare System |
Responsible Party: | Yale University ( Ismene Petrakis ) |
Study ID Numbers: | 00030, 0705002634 |
Study First Received: | December 7, 2007 |
Last Updated: | August 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00571246 |
Health Authority: | United States: Institutional Review Board |
treatment Lamotrigine Topiramate alcohol dependence post traumatic stress disorder |
Stress Disorders of Environmental Origin Stress Disorders, Traumatic Calcium, Dietary Anxiety Disorders Mental Disorders Alcoholism |
Substance-Related Disorders Lamotrigine Stress Disorders, Post-Traumatic Topiramate Alcohol-Related Disorders Ethanol |
Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Blockers Cardiovascular Agents Neuroprotective Agents Protective Agents |
Pharmacologic Actions Membrane Transport Modulators Anti-Obesity Agents Pathologic Processes Therapeutic Uses Central Nervous System Agents Anticonvulsants |