Topiramate Treatment of Problem Drinkers

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00626925
• Date of registration: 21/02/2008
• Primary sponsor: University of Connecticut Health Center
• Public title: Topiramate Treatment of Problem Drinkers
• Scientific title: Topiramate Treatment of Problem Drinkers
• Date of first enrolment: February 2008
• Target sample size: 160
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00626925
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Timothy S Pond, MPH

• Name: Timothy S Pond, MPH

• Name: Henry R Kranzler, M.D.
• Affiliation: University of Pennsylvania

Key inclusion & exclusion criteria

Inclusion Criteria:

- age 18 to 65 years, inclusive;

- have an average weekly ethanol consumption of >=24 standard drinks for men, or >=18
standard drinks for women;

- be able to read English at the 8th grade or higher level and show no evidence of
significant cognitive impairment;

- be willing to nominate an individual who will know the patient's whereabouts in order
to facilitate follow up during the study;

- if a woman of child-bearing potential (i.e., who has not had a hysterectomy,
bilateral oophorectomy, tubal ligation or who are less than two years
postmenopausal), must be non-lactating, practicing a reliable method of birth
control, and have a negative serum pregnancy test prior to initiation of treatment;

- if applicable, individuals being treated with a single antidepressant that has been
stable in dosage for a minimum of four weeks; and

- be willing to provide signed, informed consent to participate in the study (including
a willingness to reduce drinking to non-hazardous levels).

Exclusion Criteria:

- a current, clinically significant physical disease or abnormality on the basis of
medical history, physical examination, or routine laboratory evaluation, including
direct bilirubin elevations of >110% or transaminase elevations >300% normal (We will
not exclude patients with hypertension, diabetes mellitus, asthma or other common
medical conditions, as long as these are adequately controlled and the patient has an
ongoing relationship with a primary-care practitioner);

- a history of nephrolithiasis;

- a history of glaucoma;

- a serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or
psychotic major depression, panic disorder, borderline or antisocial personality
disorder, organic mood or mental disorders, eating disorder, or substantial suicide
or violence risk) on the basis of history or psychiatric examination;

- a current Diagnostic & Statistical Manual of Mental Disorders 4th ed (DSM-IV)
diagnosis of drug dependence (other than nicotine dependence);

- a current Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV)
diagnosis of alcohol dependence that is clinically moderate or severe;

- a history of hypersensitivity to topiramate;

- currently taking any tricyclic antidepressant (e.g., Adapin (doxepin), Anafranil
(clomipramine), Elavil (amitryptyline), Pamelor (nortryptyline), Tofranil
(imipramine), Sinequan (doxepin); or

- are considered by the investigators to be an unsuitable candidate for receipt of an
investigational drug.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alcohol Drinking

Intervention(s)

Drug: placebo

Drug: topiramate

Primary Outcome(s)

drinking days and heavy drinking days [Time Frame: 12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment]

Secondary Outcome(s)

change in gamma-glutamyl transferase (GGT) or carbohydrate-deficient transferrin (CDT) levels [Time Frame: 12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment]

mean daily alcohol consumption [Time Frame: 12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment]

severity of alcohol-related problems (as measured on the Short Inventory of Problems; SIP) [Time Frame: 12 weeks (from intiation to end of treatment); 3- and 6-months post-treatment]

Secondary ID(s)

08-052-2

P60AA03510-5

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Research Resources (NCRR)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)