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

• Status: Withdrawn
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elizabeth Ralevski; Yale University
• Treatments: Anticonvulsants; Ethanol; Lamotrigine; Topiramate

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.