Bright White Light Therapy During Cocaine Detoxification

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CokeLux is a multicenter, randomized, sham-controlled, double-blind trial evaluating the use of a medical light therapy device during hospital-based cocaine detoxification. After a 10 to 17 day inpatient detox, participants will discontinue the intervention but continue follow-up data collection for one month. The study compares active light therapy to a sham device, with outcomes assessed in the hospital and after discharge. The trial design includes pre-hospitalization assessment and longitudinal data collection to monitor safety, withdrawal symptoms, and abstinence-related metrics. It targets adults with cocaine use disorder undergoing supervised detoxification and follows standard clinical research governance for medical devices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, 18 years of age or older
* DSM-5 criteria for cocaine use disorder
* Positive urine screen for cocaine
* Hospitalization for supervised cocaine detoxification planned within the four upcoming weeks
* The patients must be insured or beneficiary of a health insurance plan
* Signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the trial

Exclusion Criteria:

* Non-stabilized opioid use disorder or other psychostimulant use disorder (e.g., amphetamine, met-amphetamine, cathinones, methylphenidate…)
* Non-stabilized psychiatric disorder or somatic disease, which is considered incompatible with inclusion by the investigator
* Current treatment with methylphenidate, modafinil, solriamfetol, melatonin pitolisant, naltrexone, or bupropion.
* Contraindication to light therapy: retinopathy, pigmentary retinitis, diabetic retinopathy, macular degeneration, glaucoma, recent (i.e., less than three month) eye surgery. (If there is any doubt about an ophthalmological contraindication, a specialist opinion will be requested)
* Tutorship
* Pregnant or breastfeeding women: the performance of a pregnancy test before inclusion for women of childbearing age
* Persons deprived of their liberty by a judicial or administrative decision
* Persons participating in other research with an exclusion period still in progress at pre-inclusion

Where it's running

• Centre Hospitalier Le Vinatier
  Bron, Auvergne-Rhône-Alpes, France Recruiting

Study contacts

• Principal investigator: BENJAMIN ROLLAND, MD, PhD — Centre Hospitalier le Vinatier
• Study coordinator: FLORELLE BERTRAND, PhD
• Email: florelle.bertrand@ch-le-vinatier.fr
• Phone: 0033437915540

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.