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

Primary Purpose

Alcohol Dependence, Post Traumatic Stress Disorder

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Topiramate

lamotrigine

Placebo

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring treatment, Lamotrigine, Topiramate, alcohol dependence, post traumatic stress disorder

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and females between the ages of 18-60 years old.
Current alcohol abuse or dependence
Current PTSD
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.
Individuals who are on a stable dose (no less than 2 weeks) of antidepressant medication.
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)
For women, negative pregnancy test and use of acceptable method of contraception.

Exclusion Criteria:

Females who are pregnant or lactating.
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).
Patients who meet current SCID criteria for a major Axis I diagnosis (Bipolar Disorders, Schizophrenia and Schizophrenia-type Disorders).
History of substance dependence (other than alcohol, tobacco or cannabis) by DSM-IV criteria in the last 90 days.
Individuals taking mood stabilizers and antipsychotic medications.
Individuals with a history of allergies to topiramate or lamotrigine.

Sites / Locations

VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Topiramate

Lamotrigine

Placebo

Arm Description

Participants will be randomized to topiramate (250mg)

Participants will be randomized to lamotrigine (250mg)

Participants will be randomized placebo

Outcomes

Primary Outcome Measures

drinking - measured using the TLFB

craving - measured using the OCDS

PTSD symptoms - measured using the CAPS

Secondary Outcome Measures

Full Information

NCT ID

NCT00571246

First Posted

December 7, 2007

Last Updated

November 12, 2020

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT00571246

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Withdrawn

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence, Post Traumatic Stress Disorder

Keywords

treatment, Lamotrigine, Topiramate, alcohol dependence, post traumatic stress disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topiramate

Arm Type

Experimental

Arm Description

Participants will be randomized to topiramate (250mg)

Arm Title

Lamotrigine

Arm Type

Experimental

Arm Description

Participants will be randomized to lamotrigine (250mg)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will be randomized placebo

Intervention Type

Drug

Intervention Name(s)

Topiramate

Intervention Description

Participants are randomized to take Topiramate (250mg/day) 2 times a day

Intervention Type

Drug

Intervention Name(s)

lamotrigine

Intervention Description

Participants are randomized to take Lamotrigine (250 mg/day) 2 times a day

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Participants are randomized to take placebo

Primary Outcome Measure Information:

Title

drinking - measured using the TLFB

Time Frame

16 weeks

Title

craving - measured using the OCDS

Time Frame

16 weeks

Title

PTSD symptoms - measured using the CAPS

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females between the ages of 18-60 years old. Current alcohol abuse or dependence Current PTSD 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. Individuals who are on a stable dose (no less than 2 weeks) of antidepressant medication. 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) For women, negative pregnancy test and use of acceptable method of contraception. Exclusion Criteria: Females who are pregnant or lactating. 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). Patients who meet current SCID criteria for a major Axis I diagnosis (Bipolar Disorders, Schizophrenia and Schizophrenia-type Disorders). History of substance dependence (other than alcohol, tobacco or cannabis) by DSM-IV criteria in the last 90 days. Individuals taking mood stabilizers and antipsychotic medications. Individuals with a history of allergies to topiramate or lamotrigine.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ismene L Petrakis, MD

Organizational Affiliation

VA Connecticut Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Connecticut Healthcare System

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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