Alcohol Use DisorderLUNANCT06878287
Bright Light Therapy During Residential Alcohol Withdrawal
A study testing Light exposure in people with Alcohol Use Disorder and Alcohol Withdrawal, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
This is a randomized controlled trial assessing the effectiveness of light therapy versus placebo in patients undergoing alcohol withdrawal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Withdrawal
- What is being tested?
- Light exposure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2022to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Adult Emergency Department - Bichât Hospital
Paris, Île-de-France Region, 75018
Michel LEJOYEUX, Psychiatrist, 01 40 25 82 62
About this study
Official title: Bright Light Therapy During Residential Alcohol Withdrawal : a Double Blind Randomized Placebo Controlled Study
This is a randomized controlled trial assessing the effectiveness of light therapy versus placebo in patients undergoing alcohol withdrawal.
Read the 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):
- 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
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal
- Being tested
- Light exposure, Placebo light
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light exposureOther
30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking)
Placebo lightOther
30 minutes exposure to the same device using a filter inactivating light intensity (< 10 lux)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Light therapy every morning (8 am-8.30 am) Receives: Other: Light exposure |
| Control group | Placebo comparator | Dim-Light exposure every morning (8 am-8.30 am) Receives: Other: Placebo light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 and 12 weeks
Secondary outcomes (20)
Actigraphy
Wristwatch actigraph delivered at inclusion, which allows measurement of activity and sleep-wake parameters using an accelerometer worn on the wrist MotionWatch8 from CamNTech®
Measured: 1 day and third week
Alcohol withdrawal severity
Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) : maximum and mean score on the first 5 days after admission
Measured: 2 weeks
Circadian typology
Chronotype questionnaire (Horne \& Östberg) a
Measured: At inclusion
Alcohol craving
Obsessive Compulsive Drinking Scale (OCDS)
Measured: At inclusion, 1, 2, 4 and 12 weeks
Depressive and anxious symptomatology
- Montgomery-Åsberg Depression Rating Scale (MADRS)
- Self-questionnaire : QIDS-SD16 and GAD-7
Measured: At inclusion, 1, 2, 4 and 12 weeks
Suicidal risk
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: At inclusion, 1, 2, 4 and 12 weeks
Cognitive impairment
Montreal Cognitive Assessment (MoCA) : three different versions
Measured: At inclusion, 2 and 12 weeks
Light therapy tolerance
Side effects questionnaire designed for a previous study
Measured: At 2 weeks
Polysomnography
Sleep recording at the sleep laboratory, measuring :
- Sleep stages
- Total Sleep Time
- Sleep Efficiency
- Number of awakenings or arousals
- Snoring
- Apnea-Hypopnea Index (AHI)
- Periodic Limb Movements
Measured: 1 week
Subjective quality of sleep
Pittsburgh Sleep Quality Index (PSQI)
Measured: 12 weeks
Number of days with 2 drinks or more
% of days with 2 drinks or more at the follow-up visits
Measured: 4, 12 weeks
Heavy drinking days
% of heavy drinking days at the follow-up visits
Measured: 4, 12 weeks
Days with no drinking
% of days with no drinking at the follow-up visits
Measured: 4, 12 weeks
Percent with complete abstinence
% of subjects with no drinking at the follow-up visits
Measured: 4 and 12 weeks
Number of individuals in relapse
% of subjects meeting criteria for relapse at the follow-up visits
Measured: 4 , 12 weeks
Sleep diary
sleep diary.give at the first appointment then fill in every day
Measured: From inclusion to third week
Circadian typology
seasonal profile (SPAQ)
Measured: one day
Actigraphy
Wristwatch actigraph delivered at inclusion, which allows measurement of activity and sleep-wake parameters using an accelerometer worn on the wrist ScanWatch from Withings®
Measured: one day to third week
Alcohol withdrawal severity
mean benzodiazepine dosage required by day during the 2 weeks of treatment
Measured: one day to 2 weeks
Subjective quality of sleep
Insomnia Severity Index (ISI)
Measured: one day, 2 day to12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start31 May 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Alexis GEOFFROY, PhD, Principal investigator, University Hospital Group for Psychiatry and Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878287
- Sponsor's protocol ID
- D20-P49
- Acronym
- LUNA
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy During Residential Alcohol Withdrawal : a Double Blind Randomized Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT06878287
- Acronym / sponsor ID
- LUNA / D20-P49
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Other: Light exposureLight therapy every morning (8 am-8.30 am) |
| Control group | Placebo comparator | Other: Placebo lightDim-Light exposure every morning (8 am-8.30 am) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light exposure30 minutes morning exposure to light (10 000 lux) using a light-box device filtering UV (CE marking) | Other | Experimental group |
| Placebo light30 minutes exposure to the same device using a filter inactivating light intensity (< 10 lux) | Other | Control group |
Primary outcome
Alcohol relapse or lapse
Time frame: 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
20 secondary outcomes
Actigraphy
Time frame: 1 day and third week
Alcohol withdrawal severity
Time frame: 2 weeks
Circadian typology
Time frame: At inclusion
Alcohol craving
Time frame: At inclusion, 1, 2, 4 and 12 weeks
Depressive and anxious symptomatology
Time frame: At inclusion, 1, 2, 4 and 12 weeks
Suicidal risk
Time frame: At inclusion, 1, 2, 4 and 12 weeks
Cognitive impairment
Time frame: At inclusion, 2 and 12 weeks
Light therapy tolerance
Time frame: At 2 weeks
Polysomnography
Time frame: 1 week
Subjective quality of sleep
Time frame: 12 weeks
Number of days with 2 drinks or more
Time frame: 4, 12 weeks
Heavy drinking days
Time frame: 4, 12 weeks
Days with no drinking
Time frame: 4, 12 weeks
Percent with complete abstinence
Time frame: 4 and 12 weeks
Number of individuals in relapse
Time frame: 4 , 12 weeks
Sleep diary
Time frame: From inclusion to third week
Circadian typology
Time frame: one day
Actigraphy
Time frame: one day to third week
Alcohol withdrawal severity
Time frame: one day to 2 weeks
Subjective quality of sleep
Time frame: one day, 2 day to12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Alexis GEOFFROY, PhD principal investigator
University Hospital Group for Psychiatry and Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light exposure in people with Alcohol Use Disorder and Alcohol Withdrawal, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Alexis GEOFFROY, PhD (+33140256048, pierrealexis.geoffroy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol relapse or lapse (time frame: 4 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.