Bright Light Therapy During Residential Alcohol Withdrawal

NCT06878287 | Recruiting

• 1 other identifier: D20-P49
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial assessing the effectiveness of light therapy versus placebo in patients undergoing alcohol withdrawal.

Conditions

Alcohol Use Disorder; Alcohol Withdrawal

Outcome Measures

Primary Outcomes (1)

• Alcohol relapse or lapse

  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

  4 and 12 weeks

Secondary Outcomes (20)

• Actigraphy

  1 day and third week

• Alcohol withdrawal severity

  2 weeks

• Circadian typology

  At inclusion

• Alcohol craving

  At inclusion, 1, 2, 4 and 12 weeks

• Depressive and anxious symptomatology

  At inclusion, 1, 2, 4 and 12 weeks

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Light therapy every morning (8 am-8.30 am)

Other: Light exposure

Control group

PLACEBO COMPARATOR

Dim-Light exposure every morning (8 am-8.30 am)

Other: Placebo light

Interventions

Light exposure OTHER

30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking)

Experimental group

Placebo light OTHER

30 minutes exposure to the same device using a filter inactivating light intensity (\< 10 lux)

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

Adult Emergency Department - Bichât Hospital

Paris, Île-de-France Region, 75018, France

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Pierre Alexis GEOFFROY, PhD

  University Hospital Group for Psychiatry and Neurosciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Alexis GEOFFROY, PhD

CONTACT

+33140256048; pierrealexis.geoffroy@aphp.fr

Sibylle MAURIES, Ph

CONTACT

+330140256272; sibylle.mauries@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: March 14, 2025
• Study Start: May 31, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2024-09

Locations

FR (1)