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The Use of Anticonvulsants for Treatment of Patients With Alcohol Dependence and Post Traumatic Stress Disorder

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Ralevski, Yale University
ClinicalTrials.gov Identifier:
NCT00571246
First received: December 7, 2007
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Alcohol Dependence
Post Traumatic Stress Disorder
 Drug: lamotrigine and topiramate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Anticonvulsants for Treatment of Patients With Alcohol Dependence and Post Traumatic Stress Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • drinking - measured using the TLFB [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • craving - measured using the OCDS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • PTSD symptoms - measured using the CAPS [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lamotrigine and topiramate
    lamotrigine (250 mg/day) 2 times a day, topiramate (250mg/day) 2 times a day, placebo
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females between the ages of 18-60 years old.
  2. Current alcohol abuse or dependence
  3. Current PTSD
  4. Patients with current alcohol dependence, with at least one recent episode of heavy drinking (defined as 5 or more drinks per drinking episode) over the past 14 days, and during a consecutive 30-day period within the 90 days prior to baseline evaluation.
  5. Individuals who are on a stable dose (no less than 2 weeks) of antidepressant medication.
  6. Medically and neurologically healthy on the basis of history, physical examination, EKG, screening laboratories (CBC w/ differential, TSH, Free-T4, ASAT, ALAT, GGT, BUN, creatinine, calcium, phosphorous, magnesium, total protein, albumin, electrolytes, VDRL, urinalysis, beta-HCG)
  7. For women, negative pregnancy test and use of acceptable method of contraception.

Exclusion Criteria:

  1. Females who are pregnant or lactating.
  2. Individuals with a current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology (LFT > 3 times normal, abnormal BUN and creatinine, and unmanaged hypertension with BP > 200/120) which in the opinion of the physician would preclude the patient from fully cooperating or be of potential harm during the course of the study (includes those with a history of glaucoma, prostatic hypertrophy, urethral obstruction, cerebral arteriosclerosis, pyloric stenosis).
  3. Patients who meet current SCID criteria for a major Axis I diagnosis (Bipolar Disorders, Schizophrenia and Schizophrenia-type Disorders).
  4. History of substance dependence (other than alcohol, tobacco or cannabis) by DSM-IV criteria in the last 90 days.
  5. Individuals taking mood stabilizers and antipsychotic medications.
  6. Individuals with a history of allergies to topiramate or lamotrigine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571246

Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Elizabeth Ralevski
Investigators
Principal Investigator: Ismene L Petrakis, MD VA Connecticut Healthcare System
  More Information

No publications provided

Responsible Party: Elizabeth Ralevski, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00571246     History of Changes
Other Study ID Numbers: 00030, 0705002634
Study First Received: December 7, 2007
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
treatment
Lamotrigine
Topiramate
alcohol dependence
post traumatic stress disorder

Additional relevant MeSH terms:
Alcoholism
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Anxiety Disorders
Lamotrigine
Topiramate
Anticonvulsants
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on May 23, 2013