Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00571246
Other study ID # 0705002634
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date June 2012
Est. completion date June 2016

Study information

Verified date November 2020
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Drug:
Topiramate
Participants are randomized to take Topiramate (250mg/day) 2 times a day
lamotrigine
Participants are randomized to take Lamotrigine (250 mg/day) 2 times a day
Other:
Placebo
Participants are randomized to take placebo

Locations

Country Name City State
United States VA Connecticut Healthcare System West Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary drinking - measured using the TLFB 16 weeks
Primary craving - measured using the OCDS 16 weeks
Primary PTSD symptoms - measured using the CAPS 16 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Recruiting NCT05934162 - Efficacy of Internet-delivered Cognitive-behavior Therapy for PTSD N/A
Recruiting NCT05934175 - Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder N/A
Completed NCT04460014 - Simple Cognitive Task Intervention After Trauma During COVID-19 In Hospital Staff EKUT-P RCT N/A
Completed NCT05877807 - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Active, not recruiting NCT05992649 - The Effect of Aquatic Physiotherapy on Veterans Suffering From PTSD - a 40-week Pilotproject N/A
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Not yet recruiting NCT05331534 - Effect of Attentional Therapy on Post-traumatic Stress Disorder N/A
Not yet recruiting NCT04076215 - Biochemical and Physiological Response to Stressogenic Stimuli N/A
Not yet recruiting NCT03649607 - Accelerated Resolution Therapy for HIV Positive African, Caribbean and Black N/A
Not yet recruiting NCT02545192 - A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments Phase 1
Completed NCT02329418 - Written Document to Assist Family During Decision of Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit N/A
Active, not recruiting NCT00978484 - A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder Phase 3
Completed NCT00760734 - Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT03278171 - Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit
Recruiting NCT05874362 - People Bereaved by Violent Death : Negative Event Biases and Temporal Perception N/A
Terminated NCT03898843 - Assisted Animal Therapy: ReAnimal N/A
Recruiting NCT04747379 - Psychological Effect of Explicit Recall After Sedation (PEERS)
Completed NCT03248167 - Cannabidiol as a Treatment for AUD Comorbid With PTSD Phase 1/Phase 2