NCT00571246

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
4.5 years until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

4 years

First QC Date

December 7, 2007

Last Update Submit

November 12, 2020

Conditions

Alcohol DependencePost Traumatic Stress Disorder

Keywords

treatmentLamotrigineTopiramatealcohol dependencepost traumatic stress disorder

Outcome Measures

Primary Outcomes (3)

  • drinking - measured using the TLFB

    16 weeks

  • craving - measured using the OCDS

    16 weeks

  • PTSD symptoms - measured using the CAPS

    16 weeks

Study Arms (3)

Topiramate

EXPERIMENTAL

Participants will be randomized to topiramate (250mg)

Drug: Topiramate

Lamotrigine

EXPERIMENTAL

Participants will be randomized to lamotrigine (250mg)

Drug: lamotrigine

Placebo

PLACEBO COMPARATOR

Participants will be randomized placebo

Other: Placebo

Interventions

TopiramateDRUG

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

Topiramate
lamotrigineDRUG

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

Lamotrigine
PlaceboOTHER

Participants are randomized to take placebo

Placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

AlcoholismStress Disorders, Post-Traumatic

Interventions

TopiramateLamotrigine

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetosesTriazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ismene L Petrakis, MD

    VA Connecticut Healthcare System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 11, 2007

Study Start

June 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 16, 2020

Record last verified: 2020-11

Locations

US(1)