Phase 4
Completed N=138
Topiramate Treatment of Problem Drinkers
Alcohol Drinking
Source: ClinicalTrials.gov NCT00626925 ↗
Enrolled (actual)
138
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Mean Heavy Drinking Days Per Week by Medication Group — 1.82; 2.94 Number of heavy drinking days — p=0.001
Summary
The purpose of this study is to evaluate the safety and efficacy of topiramate in reducing drinking and heavy drinking frequency in problem drinkers. We hypothesize that at a dosage of up to 200mg/day, topiramate will be well tolerated in this patient population and that, compared to placebo treatment, topiramate will result in a greater reduction in the frequency of both drinking days and heavy drinking days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Heavy Drinking Days Per Week by Medication Group |
1.82; 2.94 | 0.001 sig |
| SECONDARY Mean Abstinent Days Per Week by Medication Group |
2.00; 1.36 | 0.01 sig |
| SECONDARY Mean Daily Alcohol Consumption |
2.9859; 3.5523; 2.6129; 2.7560; 2.6448; 2.8377 | — |
| SECONDARY Mean Heavy Drinking Days Per Week by Medication Group and rs2832407 Genotype |
1.28; 3.49; 2.30; 2.72; 1.8; 1.54 | 0.004 sig |
| SECONDARY Mean Abstinent Days Per Week by Medication Group and rs2832407 Genotype |
2.41; 1.02; 1.51; 1.44; 2.26; 2.49 | 0.04 sig |
| SECONDARY Severity of Alcohol-related Problems at End of Treatment |
7.0; 11.1 | 0.001 sig |
| SECONDARY Gamma-glutamyl Transferase (GGT) at Midpoint |
37.6; 50.1 | 0.06 |
| SECONDARY Gamma-glutamyl Transferase (GGT) at End of Treatment |
36.3; 47.9 | 0.01 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00626925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.