Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Cognitive side effects
研究概览
简要总结
This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) + N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo for the treatment of alcohol use disorder (AUD).
详细描述
This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) + N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo in 16 subjects enrolled in a 12 week, randomized, double-blind, outpatient trial. Each subject will receive randomly one of the drug combinations for 12 weeks plus medication management.
Primary Aim 1: To evaluate the safety, tolerability of Topiramate (TPM) and N-Acetyl Cysteine (NAC) in combination or Topiramate (TPM) + placebo for the treatment of Alcohol Use Disorder (AUD). This aim will be accomplished by testing the following:
•Hypothesis 1 - The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) will be well tolerated by participants as evidenced by less self-report cognitive side effects (word finding difficulties, difficulties with concentration, and confusion).
Secondary Aim 1: The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) or Topiramate (TPM) + Placebo will reduce alcohol drinking. This aim will be accomplished by testing the following:
•Hypothesis 2 - The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) or Topiramate (TPM) + Placebo will reduced alcohol drinking , as evidenced by a statistically significant reduction in percentage of heavy drinking days (PHDD) as compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Ages 18 and above
- •Good physical health
- •Current DSM-V diagnosis of alcohol use disorder
- •Currently drinking ≥21 alcohol units/week for women and ≥28 alcohol units/week for men on average in the last 28 days prior to screen.
- •Be seeking treatment for problems with alcohol
- •Be able to take oral medication and be willing to adhere to the medication regimen.
- •Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
- •Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
- •Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
- •The pregnancy test for females at screen and prior to randomization must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide.
排除标准
- •Please contact site for additional information
研究组 & 干预措施
Topiramate and Placebo
Drug: Topiramate and Placebo Other Name for Topiramate: Topamax Other Name for Placebo: Sugar Pill
干预措施: Topiramate and Placebo (Drug)
Topiramate and N-Acetyl Cysteine
Drug: Topiramate and N-Acetyl Cysteine Other Name for Topiramate: Topamax
干预措施: Topiramate and N-Acetyl Cysteine (Drug)
结局指标
主要结局
Cognitive side effects
时间窗: up to13 weeks
Collection of self-report cognitive side effects
次要结局
- Percent Heavy Drinking Days (PHDD)(up to 13 weeks)
- Drinks per Drinking Day(up to 13 weeks)
- Percentage of Days Abstinent(up to 13 weeks)
- Obsessive compulsive drinking scale (OCDS)(up to 16 weeks)
- Drinking Inventory of Consequence (DrInC) scale(DrInC is at screen, weeks 1,5,9, and 13)
- Clinical Global Improvement (CGI) scale(up to 16 weeks)
研究者
Nassima Ait-Daoud Tiouririne
Associate Professor, Director of UVA Center for Leading Edge Addiction Research
University of Virginia