Bright Light Therapy During Residential Alcohol Withdrawal : a Double Blind Randomized Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Alcohol relapse or lapse
研究概览
简要总结
This is a randomized controlled trial assessing the effectiveness of light therapy versus placebo in patients undergoing alcohol withdrawal.
详细描述
All eligible patients will be offered and explained the study by a psychiatrist/addictologist during the consultation (or teleconsultation) to schedule a 14-day hospitalization for alcohol withdrawal (maximum 3 months before hospitalization). Patients will be randomized centrally to one of the following two treatment conditions (blind maintained by a nurse independent of the assessment), on day D0 of inpatient treatment for withdrawal (standardized withdrawal over 14 days with hydration, vitamin B1, benzodiazepines in gradual decrease before stopping and according to signs of withdrawal):
- Active light therapy (10,000 Lux).
- Placebo light therapy (with filter <10 Lux). Every morning in the room (patient in a single room), at 8 am, for 30 min, for the entire duration of withdrawal, i.e. 13 days (start on D1) and stopped on D14.
No change in usual care apart from this intervention.
After checking the inclusion and non-inclusion criteria and obtaining consent, patients will be randomized (ratio 1:1) between the groups with active light therapy or placebo, by connecting to a randomization website (REDCap software) using a randomization list prepared in advance, balanced by block of randomly variable size
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be aged from 18 to 65 years old and have a diagnosis of Alcohol Use Disorder
- •Patients must be intreated for alcohol withdrawal, for at least two weeks
- •Patients must report heavy drinking episodes in the past month
- •Patients must be able to understand medical information and consent to the treatment
- •Patients must be considering a goal of abstinence from alcohol
排除标准
- •Ophthalmic pathology (cataract, macular degeneration, glaucoma, retinitis pigmentosa) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.)
- •Subjects who have already received light therapy in the last 6 months
- •Lactating of pregnant women
- •Psychiatric comorbidity requiring an intreatment, or risk of manic episode (subjects with depressive or anxious symptoms compatible with an out-treatment can be included)
- •Substance Use Disorder other than alcohol and/or tobacco
- •Severe cognitive impairment (MOCA < 10)
- •Patients being under legal protection measure
研究组 & 干预措施
Experimental group
Light therapy every morning (8 am-8.30 am)
干预措施: Light exposure (Other)
Control group
Dim-Light exposure every morning (8 am-8.30 am)
干预措施: Placebo light (Other)
结局指标
主要结局
Alcohol relapse or lapse
时间窗: 4 and 12 weeks
Assessment of alcohol intake at the follow-up visits using a Timeline Followback. Relapse : any heavy drinking day, i.e. 5 or more drinks/day for a man or 4 or more drinks/day for a woman, as defined by the NIAAA (2005) and the FDA (2015), and/or 14 drinks or more per week for at least 4 weeks. Lapse : any alcohol intake not meeting the criteria for relapse
次要结局
- Suicidal risk(At inclusion, 1, 2, 4 and 12 weeks)
- Cognitive impairment(At inclusion, 2 and 12 weeks)
- Light therapy tolerance(At 2 weeks)
- Circadian typology(one day)
- Actigraphy(one day to third week)
- Alcohol withdrawal severity(one day to 2 weeks)
- Alcohol craving(At inclusion, 1, 2, 4 and 12 weeks)
- Depressive and anxious symptomatology(At inclusion, 1, 2, 4 and 12 weeks)
- Polysomnography(1 week)
- Subjective quality of sleep(one day, 2 day to12 weeks)
- Number of days with 2 drinks or more(4, 12 weeks)
- Heavy drinking days(4, 12 weeks)
- Days with no drinking(4, 12 weeks)
- Percent with complete abstinence(4 and 12 weeks)
- Number of individuals in relapse(4 , 12 weeks)
- Sleep diary(From inclusion to third week)
- Actigraphy(1 day and third week)
- Alcohol withdrawal severity(2 weeks)
- Circadian typology(At inclusion)
- Subjective quality of sleep(12 weeks)