Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Time to lapse, as measured by the Time Line Follow Back
研究概览
简要总结
To compare the clinical effectiveness, tolerability, and cost-effectiveness of topiramate to active control (naltrexone) on treatment outcomes for alcohol dependence in a double-blind randomised controlled trial.
详细描述
Clinicians urgently require new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response.
Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities.
Members of our research team have recently demonstrated findings that support the use of topiramate (TOP) 200 mg/day to reduce heavy drinking and pharmacogenetic findings that implicate the GluK1 receptor subunit in the mechanism of these effects.
This project will evaluate the clinical effectiveness and tolerability of topiramate relative to the active control naltrexone (NTX) in heavy drinkers.
Investigators hypothesise that topiramate treated patients will be better able to achieve a reduction in heavy drinking and predict that, based on prior research, that the effects would be moderated by a single nucleotide polymorphism (rs2832407) in GRIK1.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alcohol Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders Version V criteria
- •Age 18-70
- •Average weekly alcohol consumption of >30 standard drinks for men and >25 standard drinks for women, with a weekly average of > 2 heavy drinking days during the month before screening
- •Adequate cognition and English language skills to give valid consent and complete research interviews
- •Willingness to give written informed consent
- •Willingness to provide a blood sample for genotyping
- •Written informed consent
排除标准
- •Active major psychological disorder associated with psychosis, significant suicide risk, and signs of impaired cognitive functioning
- •Pregnancy or lactation
- •Concurrent use of any psychotropic medication other than antidepressants
- •Currently taking any tricyclic antidepressant
- •Use of antiretroviral dolutegravir
- •Any substance dependence other than nicotine
- •Opioid abuse, opioid dependence, or on opioid maintenance treatment
- •Clinically significant liver disease
- •History of nephrolithiasis
- •History of glaucoma
- •Lack of stable housing and/or contact phone number
- •Previous hypersensitivity to TOP or NTX
- •Any alcohol pharmacotherapy within the past month
研究组 & 干预措施
Topiramate
Topiramate 200mg/day
干预措施: Topiramate (Drug)
Naltrexone
Naltrexone 50mg/day
干预措施: Naltrexone (Drug)
结局指标
主要结局
Time to lapse, as measured by the Time Line Follow Back
时间窗: Over 12 weeks
Corroborated with PEth levels
Number of standard drinks per drinking day, as measured by the Time Line Follow Back
时间窗: 12 weeks
Corroborated with PEth levels
Time to relapse, as measured by the Time Line Follow Back
时间窗: Over 12 weeks
Corroborated with PEth levels
Number of heavy drinking days, as measured by the Time Line Follow Back
时间窗: Over 12 weeks
Corroborated with Phosphatidylethanol (PEth) levels
Number of days abstinent, as measured by the Time Line Follow Back
时间窗: Over 12 weeks
Corroborated with PEth levels
次要结局
- Blood glucose test for diabetes(12 weeks)
- Self report of adverse events(12 weeks)
- Penn Alcohol Craving Scale for alcohol craving(12 weeks)
- DASS21 score for presence and/or severity of anxiety(12 weeks)
- Self report of daily measures of expectancies, confidence and drinking(12 weeks)
- Liver function tests for clinical markers of liver injury(12 weeks)
- Number of cigarettes smoked daily, as measured by Time Line Follow Back(12 weeks)
- Body Mass Index(12 weeks)
- DASS21 score for presence and/or severity of depression(12 weeks)
- Insomnia Severity Index for sleep disturbances(12 weeks)
研究者
Professor Paul Haber
Principle Clinical Investigator
South West Sydney Local Health District