Trials / Recruiting
RecruitingNCT06878287
Bright Light Therapy During Residential Alcohol Withdrawal
Bright Light Therapy During Residential Alcohol Withdrawal : a Double Blind Randomized Placebo Controlled Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Centre Hospitalier St Anne · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized controlled trial assessing the effectiveness of light therapy versus placebo in patients undergoing alcohol withdrawal.
Detailed description
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): 1. Active light therapy (10,000 Lux). 2. 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Light exposure | 30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking) |
| OTHER | Placebo light | 30 minutes exposure to the same device using a filter inactivating light intensity (\< 10 lux) |
Timeline
- Start date
- 2022-05-31
- Primary completion
- 2025-05-31
- Completion
- 2025-05-31
- First posted
- 2025-03-14
- Last updated
- 2025-03-14
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06878287. Inclusion in this directory is not an endorsement.