NCT03195894已完成不适用
Clinical Study of TripleA Connected to Diagnosis, Care and Aftercare of Alcohol Addiction in Outpatient Care
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 主要终点
- Percentage of Patients With no Heavy Drinking Days After 12 Months
研究概览
简要总结
The primary objective is to investigate differences in the alcohol consumption pattern between alcohol addicts receiving conventional treatment and those who receive a combination of conventional treatment and TripleA.
详细描述
The study is a 12-month open-label and randomised comparison between the control group receiving only conventional treatment and the intervention group receiving conventional treatment enhanced with TripleA.
The studies have been designed to reflect as far as possible the conventional care for alcohol dependence. The TripleA product is intended to strengthen the existing methods used during the assessment phase, treatment phase and aftercare of alcohol dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Patients in care at Addiction and Neuropsychiatry Uppsala University Hospital and at Nämndemansgården Uppsala
- •18 years or older
- •Meets at least 2 of the criteria for addiction/substance syndrome according to Diagnostic and statistical manual of mental disorders-5 (DSM-5)
- •Ability to understand and communicate in Swedish
- •Ability to handle the technical equipment used in the study (alcoholometer and Smartphone)
- •Access to a fixed place (living, place for sleeping, place where the phone can be charged
排除标准
- •Schizophrenia
- •Substance syndrome related to other substances than alcohol and nicotin
- •Lowered lung function (not able to reach acceptable expiration volume for the alcoholometer function)
- •The patient is taken care of within the frame for The Act on Care of Addicts
- •Not suitable to participate according to the Investigator
- •Has not consumed any alcohol during the 4 weeks defined as baseline timeline follow back
- •Normalized Carbohydrate Deficient Transferrin (CDT) and Phosphatidyl-Ethanol (PEth)-values in blood samples at visit 1
结局指标
主要结局
Percentage of Patients With no Heavy Drinking Days After 12 Months
时间窗: Four weeks period before the 12 months visit
Difference between the treatment arms in percentage of patients with no heavy drinking days during the 4-weeks period before the 12 months follow-up visit .
次要结局
- Percentage of Sober Patients During the Period Before the 6 Months Visit(The four weeks-period before the 6 months visit)
- Percentage of Sober Patients Before the 12 Months Visit(The four weeks-period before the 12 months visit)
- Change in Total Amount of Consumed Alcohol From the Baseline Visit to the 6 Months Visit(The four weeks-period before the baseline visit and before the 6 months visit)
- Change in Total Amount of Consumed Alcohol From the Baseline Visit to the12 Months Visit(The four weeks-period before the baseline visit and before the 12 months visit)
- Change in Number of Sober Days Before the Baseline Visit Compared to Before the 12 Months Visit(The four weeks-period before the baseline visit and before the 12 months visit)
- Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 6 Months Visit(The four weeks-period before the baseline visit and before the 6 months visit)
- Change in Heavy Alcohol Drinking Days From the Baseline Visit to the 12 Months Visit(The four weeks-period before the baseline visit and before the 12 months visit)
- Change in Number of Sober Days Before the Baseline Visit Compared to the 6 Months Visit(The four weeks-period before the baseline visit and before the 6 months visit)
- Change in Number of Standard Glasses Per Drinking Day Before the Baseline Visit Compared to Before the 6 Months Visit(The four weeks-period before the baseline visit and before the 6 months visit)
- Change in Number of Standard Glasses Before the Baseline Visit Comapred to Before the 12 Months Visit(The four weeks-period before the baseline visit and before the 12 months visit)
- Time to Heavy Drinking(From date of randomization until the date of first heavy drinking day, assessed up to 12 months)
- Change in Health Outcome, Measured With the Visual Analog Scale (EQ VAS) in EQ-5D at the Baseline Visit Compared to the 6 Months Visit(Baseline, After 6 months)
- Change in Health Outcome, Measured With the Visual Analog Scale (EQ VAS) in EQ-5D From the Baseline Visit Compared to the 12 Months Visit(Baseline, After 12 months)
- Change in Health Outcome Measured With the Questionnaire in EQ5D After 6 Months Compared to Baseline(Baseline, After 6 months)
- Change in Health Outcome, Measured With the Questionnaire in EQ-5D After 12 Months Compared to Baseline(Baseline, After 12 months)
- Percentage of Patients Who Have Reduced Their AUDIT Score After 12 Months(After 12 months)
- Percentage of Patients With Lowered AUDIT Score With at Least One Zone After 12 Months(After 12 months)
- Percentage of Patients Having a Risk Level <II (i.e. Less Than 6 AUDIT Points for Women, 8 AUDIT Points for Men) After 12 Months(After 12 months)
- Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 6 Months(Baseline, After 6 months)
- Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 12 Months(Baseline, After 12 months)
- Change in Concentration of the Alcohol Metabolite PEth at Baseline Compared to 6 Months Visit(Baseline, After 6 months)
- Change in Degree of Alcohol Dependence Measured as the Difference in SADD-points at Baseline Compared to 12 Months(Baseline, After 12 months)
- Compliance With Agreed Treatment(Baseline, After 12 months)
- Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 6 Months(Baseline, After 6 months)
- Change in Concentration of the Alcohol Metabolite CDT in the Blood at Baseline Compared to 12 Months(Baseline, After 12 months)
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