Topiramate Treatment of Problem Drinkers
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|ClinicalTrials.gov Identifier: NCT00626925|
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : August 3, 2016
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Drinking||Drug: topiramate Drug: placebo||Phase 4|
It is estimated that 30% of the general population are problem drinkers (NIAAA 2007). Despite its high prevalence, problem drinkers are understudied, particularly with respect to medications that may help them to reduce their drinking to safe levels. The study will extend to this patient population findings from a trial of topiramate, which showed the drug to be well tolerated and efficacious in moderately-severe alcohol-dependent patients (Johnson et al. 2003).
This is a 13-week, double-blind, placebo-controlled study of topiramate (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper) and medical management counseling to reduce drinking among problem drinkers (i.e., heavy drinkers without evidence of physical dependence on alcohol) who want to reduce their drinking.
Participants attend weekly study visits for the first 5 weeks and then bi-weekly visits for the last 8 weeks of the study, and are randomly assigned to receive topiramate or placebo on a daily basis. In addition to study visits, participants report daily moods, drinking, and medication usage through an Interactive Voice Response (IVR) system they call each night. In-person follow-up evaluations are conducted at 3 and 6 months post-treatment to provide a measure of the durability of treatment effects. This study also aims to examine the relation between genotype and the response to topiramate treatment.
An additional aim is to conduct a substudy to examine neural cells generated from skin fibroblast cells obtained from study participants via a skin biopsy (participation in the substudy is completely optional). Initially, we will examine variables key to reliably generating neurons from the cells and characterize these neurons using a variety of laboratory measures. A longer term goal is to compare gene expression in individuals who show a robust reduction in drinking following treatment with topiramate with those who show no beneficial treatment effects.
A second additional aim is to explore whether the therapeutic and adverse effects of topiramate are similar in patients on a stable regimen of an antidepressant to those not receiving such therapy. Although exploratory, given the absence of data that directly address this issue, we will stratify subjects by the presence or absence of current antidepressant therapy.
Careful evaluation of the study's hypotheses will provide important information on the efficacy and mechanism of effects of topiramate as a treatment for problem drinkers.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Topiramate Treatment of Problem Drinkers|
|Study Start Date :||February 2008|
|Primary Completion Date :||November 2013|
|Study Completion Date :||November 2013|
Active Comparator: Total Topiramate Group
topiramate capsules beginning at 25 mg/day with gradual increase to a maximum of 200 mg orally)
up to 200mg/day orally (over 12 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)
Other Name: Topamax
Placebo Comparator: Total Placebo Group
inactive placebo matched in appearance with topiramate capsules
placebo (12 weeks during which the dosage of study medication is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)
- Mean Heavy Drinking Days Per Week by Medication Group [ Time Frame: 12 weeks (from initiation to end of treatment) ]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.
- Mean Abstinent Days Per Week by Medication Group [ Time Frame: 12 weeks ]
- Mean Daily Alcohol Consumption [ Time Frame: 12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment ]
- Mean Heavy Drinking Days Per Week by Medication Group and rs2832407 Genotype [ Time Frame: 12 weeks ]
- Mean Abstinent Days Per Week by Medication Group and rs2832407 Genotype [ Time Frame: 12 weeks ]
- Severity of Alcohol-related Problems at End of Treatment [ Time Frame: 12 weeks (from intiation to 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.
- Gamma-glutamyl Transferase (GGT) at Midpoint [ Time Frame: 6 weeks (from initiation to 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.
- Gamma-glutamyl Transferase (GGT) at End of Treatment [ Time Frame: 12 weeks (from initiation to 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626925
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Henry R Kranzler, M.D.||University of Pennsylvania|