Alcohol Drinking Clinical Trial
Official title:
Topiramate Treatment of Problem Drinkers
Verified date | February 2018 |
Source | UConn Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
UConn Health | National Center for Research Resources (NCRR), National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Heavy Drinking Days Per Week by Medication Group | Change in the number of heavy drinking days during treatment phase of study. Drinking data were aggregated to the weekly level. The number of days per week of heavy drinking (i.e., four or more drinks in a day for women and five or more drinks in a day for men) and of abstinence were the primary outcomes. | 12 weeks (from initiation to end of treatment) | |
Secondary | Mean Abstinent Days Per Week by Medication Group | 12 weeks | ||
Secondary | Mean Daily Alcohol Consumption | 12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment | ||
Secondary | Mean Heavy Drinking Days Per Week by Medication Group and rs2832407 Genotype | 12 weeks | ||
Secondary | Mean Abstinent Days Per Week by Medication Group and rs2832407 Genotype | 12 weeks | ||
Secondary | Severity of Alcohol-related Problems at End of Treatment | The Short Inventory of Problems (SIP). The SIP, a 15-item instrument, yields a total score that ranges from 0 to 45, higher score indicating higher levels of drinking problems. The SIP was derived from the Drinker Inventory of Consequences (DrInC), which was developed for use in Project MATCH (Miller and Tonigan 1995). We (Feinn et al. 2003) have found that, like the DrInC, the SIP measures a single factor of alcohol-related problems. Given that it is substantially shorter than the DrInC, we will use the SIP as a measure of alcohol-related consequences. | 12 weeks (from intiation to end of treatment) | |
Secondary | Gamma-glutamyl Transferase (GGT) at Midpoint | Gamma-glutamyl transferase (GGT) is a liver enzyme biochemical measure used to detect liver health and function and alcohol consumption. GGT is a very sensitive measure than can change very quickly compared to other biochemical markers. | 6 weeks (from initiation to midpoint) | |
Secondary | Gamma-glutamyl Transferase (GGT) at End of Treatment | Gamma-glutamyl transferase (GGT) is a liver enzyme biochemical measure used to detect liver health and function and alcohol consumption. GGT is a very sensitive measure than can change very quickly compared to other biochemical markers. | 12 weeks (from initiation to end of treatment) |
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