The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Topiramate (Topamax)

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcoholism, Heavy Drinking, Alcohol Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Cardiac pacemaker or metal surgical implant. History of angle closure glaucoma.

Sites / Locations

Boston University Dept of Psychiatry Clinical Studies Unit

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Topiramate Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Phonetic Portion of the Controlled Word Association Test (COWAT)

Phonetic COWAT is a measure of verbal fluency. Results are in terms of number of words produced starting with a set of particular letters.This involves a comparison of baseline and Week 10 COWAT scores

Full Information

NCT ID

NCT00329407

First Posted

May 22, 2006

Last Updated

August 30, 2010

Sponsor

Boston University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00329407

Brief Title

The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Boston University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.

Detailed Description

Alcoholism is a disorder that produces extensive morbidity and mortality. Substantial progress has been made in the development of medications that can help to promote abstinence in alcohol dependent individuals. However, investigations of the most promising drugs, particularly naltrexone and acamprosate, suggest that these agents have at best moderate efficacy and there is a great need for additional medications for the treatment of alcoholism. The results of a recent study suggest that the administration of the anticonvulsant agent ,topiramate helps alcoholic individuals to maintain abstinence (Johnson et al., 2003). The objectives of this study is to determine whether topiramate will reduce the consumption of alcohol in subjects dependent on this substance, as has been previously reported.Other study objectives are to assess the abuse liability properties of topiramate in alcohol dependent subjects and to examine the effects of chronic topiramate administration on cognitive functioning. This will be a thirteen week long open label clinical trial of the effects of topiramate administration on ethanol consumption by alcohol dependent subjects. Subjects will be asked to provide informed consent and then will be screened on the same day to determine if they meet study eligibility criteria. Subjects will be asked to return to provide two urines over the following week. Baseline measures of mood, craving, withdrawal, cognitive functioning and physical health will be obtained. In the afternoon they will receive their first dose of medication. Their responses to this medication challenge will be assessed over a 3-hour period. During the drug treatment phase subjects will be asked to come to the clinic weekly for assessment and manual guided therapy during weeks 1-4 and biweekly during weeks 6-8. On day 85 subjects will be seen at the clinic for a termination visit.

6. Conditions and Keywords

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

Alcoholism

Keywords

Alcoholism, Heavy Drinking, Alcohol Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topiramate Treatment

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Topiramate (Topamax)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

70 days

Secondary Outcome Measure Information:

Title

Phonetic Portion of the Controlled Word Association Test (COWAT)

Description

Phonetic COWAT is a measure of verbal fluency. Results are in terms of number of words produced starting with a set of particular letters.This involves a comparison of baseline and Week 10 COWAT scores

Time Frame

Baseline compared to Week 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Cardiac pacemaker or metal surgical implant. History of angle closure glaucoma.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ofra Sarid-Segal, MD

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston University Dept of Psychiatry Clinical Studies Unit

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Alcoholism

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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