Clinical trial NCT06878287: Bright Light Therapy During Residential Alcohol Withdrawal
Official title: Bright Light Therapy During Residential Alcohol Withdrawal : a Double Blind Randomized Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Alcohol Withdrawal
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Alcohol relapse or lapse
timeFrame: 4 and 12 weeks
Secondary outcomes:
measure: Actigraphy
timeFrame: 1 day and third week
measure: Alcohol withdrawal severity
timeFrame: 2 weeks
measure: Circadian typology
timeFrame: At inclusion
measure: Alcohol craving
timeFrame: At inclusion, 1, 2, 4 and 12 weeks
measure: Depressive and anxious symptomatology
timeFrame: At inclusion, 1, 2, 4 and 12 weeks
measure: Suicidal risk
timeFrame: At inclusion, 1, 2, 4 and 12 weeks
measure: Cognitive impairment
timeFrame: At inclusion, 2 and 12 weeks
measure: Light therapy tolerance
timeFrame: At 2 weeks
measure: Polysomnography
timeFrame: 1 week
measure: Subjective quality of sleep
timeFrame: 12 weeks
measure: Number of days with 2 drinks or more
timeFrame: 4, 12 weeks
measure: Heavy drinking days
timeFrame: 4, 12 weeks
measure: Days with no drinking
timeFrame: 4, 12 weeks
measure: Percent with complete abstinence
timeFrame: 4 and 12 weeks
measure: Number of individuals in relapse
timeFrame: 4 , 12 weeks
measure: Sleep diary
timeFrame: From inclusion to third week
measure: Circadian typology
timeFrame: one day
measure: Actigraphy
timeFrame: one day to third week
measure: Alcohol withdrawal severity
timeFrame: one day to 2 weeks
measure: Subjective quality of sleep
timeFrame: one day, 2 day to12 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Adult Emergency Department - Bichât Hospital
state: Île-de-France
Study officials:
affiliation: University Hospital Group for Psychiatry and Neurosciences
name: Pierre Alexis GEOFFROY, PhD
role: PRINCIPAL_INVESTIGATOR
References: