Health TrialsbyHealthPanel

Bright Light Therapy During Residential Alcohol Withdrawal

ConditionsAlcohol Use DisorderAlcohol Withdrawal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre Hospitalier St Anne

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Light exposure

    Other intervention

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

  • Placebo light

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental groupActive comparator 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
4 and 12 weeks

Secondary outcomes

1

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®

Time frame
1 day and third week
2

Alcohol withdrawal severity

Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) : maximum and mean score on the first 5 days after admission

Time frame
2 weeks
3

Circadian typology

Chronotype questionnaire (Horne \& Östberg) a

Time frame
At inclusion
4

Alcohol craving

Obsessive Compulsive Drinking Scale (OCDS)

Time frame
At inclusion, 1, 2, 4 and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier St Anne

Lead sponsor

Source ClinicalTrials.gov
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