The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects

NCT00329407 | Completed Phase 4 Results

• 1 other identifier: H-22296
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation will assess the effectiveness of topiramate in reducing ethanol consumption by alcohol dependent subjects. It also will seek to establish whether topiramate can be safely used in this population including whether it might be subject to abuse by alcohol dependent individuals. A secondary goal of this study is to assess the effects of topiramate on verbal fluency during treatment for alcohol dependence.

Conditions

Alcoholism

Keywords

Alcoholism; Heavy Drinking; Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure Will be Subjects Ethanol Consumption Over the Course of the Drug Treatment Period as Assessed by the Timeline Followback Method

  The primary outcome was the mean daily consumption of standard alcoholic drinks (14 g per ethanol) during the baseline week compared to week 10, the final week subjects were one maintenance dose of topirmate.

  70 days

Secondary Outcomes (1)

• Phonetic Portion of the Controlled Word Association Test (COWAT)

  Baseline compared to Week 10

Study Arms (1)

Topiramate Treatment

ACTIVE COMPARATOR

In this open label non-placebo controlled trial all subjects received topiramate, the active medication. Medication Dosing Schedule: Days 1-3 50 mg q PM Days 4-7 50 mg BID Days 8-11 50 mg q AM \& 100 mg q PM Days 12-15 100mg BID Days 16-19 100 mg q AM \& 150 mg q PM Days 20-23 150 mg BID Days 24-27 150 mg qAM \& 200 mg q PM Days 28-70 200 mg BID Days 71-77 150 mg BID Days 78-84 100mg BID Days 85-87 50 mg BID Days 88-91 50 mg qPM

Drug: Topiramate (Topamax)

Interventions

Topiramate (Topamax) DRUG

Medication Dosing Schedule: Days 1-3 50 mg q PM Days 4-7 50 mg BID Days 8-11 50 mg q AM \& 100 mg q PM Days 12-15 100mg BID Days 16-19 100 mg q AM \& 150 mg q PM Days 20-23 150 mg BID Days 24-27 150 mg qAM \& 200 mg q PM Days 28-70 200 mg BID Days 71-77 150 mg BID Days 78-84 100mg BID Days 85-87 50 mg BID Days 88-91 50 mg qPM

Topiramate Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV Diagnosis of Alcohol Dependence; Minimal drinking level of 14 drinks per week for women and 20 drinks per week for men over a consecutive 30 day period during the last 90 days
• Intent to stop drinking
• Male or female age 18-65
• Able to maintain sobriety for 3 consecutive days without the use of detoxification medications
• Able to provide informed consent and to comprehend study procedures.
• If a woman, then is willing to use an effective means of birth control during throughout the study period. These include: a. barrier (diaphragm or condom) with spermicide b.intrauterine progesterone contraceptive system c. levonorgestrel implant d. medroxyprogesterone acetate contraceptive injection e. complete abstinence

You may not qualify if:

• Dependent on or extensive abuse of drugs or substances other than ethanol, nicotine, or caffeine as assessed by urine toxicology (2 out of 3 Dependent on or extensive abuse of drugs or substances other than positive consecutive urines)
• DSM IV Axis I diagnoses other than ethanol, caffeine, or nicotine dependence severe enough to require treatment with medication or to prevent compliance with the protocol.
• Currently being treated with disulfiram (Antabuse), naltrexone (ReVia), or acamprosate
• Currently being treated with any other psychoactive or other CNS medications or a carbonic anhydrase inhibitor (e.g. acetazolamide)
• In need of medical detoxification from alcohol.
• Prior history of kidney stones.
• History of liver disease. ALT or AST 3 times higher than upper range of normal values.
• BUN or serum creatinine outside the normal range
• Major neurological disorder including seizures
• Other major diseases including severe hypertension, renal disease, or cardiac disease.
• Prior participation within 60 days in another clinical study.
• If female, a positive serum HCG or breast feeding.
• If female using oral contraceptives as a means of birth control.
• History of allergic sensitivity to topiramate
• Pending imprisonment

Sponsors & Collaborators

• Boston University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston University Dept of Psychiatry Clinical Studies Unit

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Limitations and Caveats

Limitation of this trial include the small number of subjects included and lack of blinding, and inculsion of a placebo control group. An other limitation was the testing the active medication topiramate at om=nly one dose level (i.e. 400 mg daily).

Results Point of Contact

• Title: Ofra sarid-Segal, MD
• Organization: Boston University

ofra.segal@bmc.org

617-414-1990

Study Officials

• Ofra Sarid-Segal, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 22, 2006
• First Posted: May 24, 2006
• Study Start: September 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 8, 2010
• Results First Posted: August 4, 2010

Record last verified: 2010-08

Locations

US (1)