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Report for Clinical Trial NCT00626925

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Topiramate Treatment of Problem Drinkers

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.

NCT00626925 Alcohol Drinking
MeSH: Alcohol Drinking

2 Interventions

Name: topiramate

Description: 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)

Type: Drug

Total Topiramate Group

Name: placebo

Description: 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)

Type: Drug

Total Placebo Group


Primary Outcomes

Description: 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.

Measure: Mean Heavy Drinking Days Per Week by Medication Group

Time: 12 weeks (from initiation to end of treatment)

Secondary Outcomes

Measure: Mean Abstinent Days Per Week by Medication Group

Time: 12 weeks

Measure: Mean Daily Alcohol Consumption

Time: 12 weeks (from initiation to end of treatment); 3- and 6-months post-treatment

Measure: Mean Heavy Drinking Days Per Week by Medication Group and rs2832407 Genotype

Time: 12 weeks

Measure: Mean Abstinent Days Per Week by Medication Group and rs2832407 Genotype

Time: 12 weeks

Description: 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.

Measure: Severity of Alcohol-related Problems at End of Treatment

Time: 12 weeks (from intiation to end of treatment)

Description: 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.

Measure: Gamma-glutamyl Transferase (GGT) at Midpoint

Time: 6 weeks (from initiation to midpoint)

Description: 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.

Measure: Gamma-glutamyl Transferase (GGT) at End of Treatment

Time: 12 weeks (from initiation to end of treatment)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs2832407

Mean Heavy Drinking Days Per Week by Medication Group and rs2832407 Genotype.

Mean Abstinent Days Per Week by Medication Group and rs2832407 Genotype.



HPO Nodes