ISRCTN14874035已完成未知
Cognitive mechanisms of an intervention to reduce heavy drinking: a randomised controlled trial
niversity of Manchester0 个研究点目标入组 92 人开始时间: 2019年1月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 92
研究概览
简要总结
2019 results in https://link.springer.com/article/10.1007/s10865-019-00078-5 (added 27/09/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18+
- •2. The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- •3. The participant is able to read, comprehend and record information written in English
- •4. A signed and dated written informed consent is obtained from the participant
- •5. The participant has expressed an interest in reducing current alcohol consumption
- •6. Consumption of 30 or more units of alcohol per week for men, and 20 or more units per week for women (1.5 times the UK Government guidelines of 2-3 drinks per day for women and 3-4 drinks per day for men with two nights off a week)but not meet SCID criteria for dependence
排除标准
- •1. Participants must not meet criteria for alcohol dependence as per the Structured Clinical Interview for Depression (SCID) (as assessed at online screening and during baseline interview)
- •2. Positive drug/alcohol screens on testing visits. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. Positive results for cannabinoids will be allowed given the long halflife of cannabinoid metabolites. This exclusion criteria would exclude a subject from completing the study on that day only and not the study as a whole, at the discretion of the research team
- •3. High dosage use of regular psychoactive prescription medications such as those with antidepressant or anxiolytic properties
- •4. History or presence of a neurological diagnosis (not limited to but including, for example, stroke, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, that may influence the outcome of any cognitive testing
- •5. Clinically significant head injury (e.g., requiring medical or surgical intervention)
- •6. Unwillingness or inability to follow the procedures outlined in the protocol
- •7. Significant current or past psychiatric history, including Major Depression, Generalised Anxiety Disorders, or anything that involves referral to secondary services and/or significant functional impairment
- •8. Neuroendocrine disorder, including impaired thyroid function and steroid use
- •9. Female participants who are, or may be, pregnant
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