Bright Light Therapy During Inpatient Cocaine Detoxification: a Multicenter Prospective Randomized Clinical Trial (COKELUX)

Cocaine is a major psychostimulant used to induce a state of euphoria, improved self-confidence and resistance to fatigue, with suppression of sleep. The progressive use of cocaine leads to a potentially severe addictive process, with sometimes dramatic social repercussions, a major disruption of major physiological functions, such as sleep or nutrition, and risks of psychiatric, neurological or cardiovascular complications.

Today, cocaine addiction is considered to be a growing societal problem, due to the fact that the use of this drug is becoming commonplace. There is no validated consensus or protocol for the management of cocaine addiction and no validated pharmacological treatment. The main therapeutic strategy for cocaine addiction is to organize a supervised cessation of use (withdrawal), followed by assistance in maintaining cessation. Withdrawal is a sensitive period that frequently takes place in a hospital setting, as withdrawal symptoms can occur, with major disruption of circadian rhythms, night-time awakenings, daytime sleepiness, high irritability, and sometimes depression.

Reducing the desynchronization of nychthemeral cycles during cocaine withdrawal could be a simple strategy to improve the addictive prognosis and comfort of patients. Light therapy is a medical device consisting of the emission of white light enriched with blue light by a lamp or glasses with an intensity sufficient to stimulate the melanopsin cells of the retina and mimic daylight. Overall, light therapy improves sleep quality, mood, cognitive abilities, and decreases fatigue through direct activation of non-visual brain structures. Given the links between cocaine withdrawal and altered sleep or rhythms, there is some evidence to suggest that light therapy used during cocaine withdrawal may improve the prognosis of patients with cocaine addiction.

Study Overview

• Status: Not yet recruiting
• Conditions: Cocaine-Related Disorders
• Intervention / Treatment: Device: Medical light therapy device; Device: Medical light therapy device sham

Detailed Description

CokeLux is a multicenter, randomized, sham-controlled, double blind clinical trial, which corresponds to a clinical investigation with a category 4.3 medical device.

After an initial pre-hospitalization assessment, which will include clinical and sociodemographic parameters, participants will undergo a hospital-based cocaine detoxification which will last 10 to 17 days. After discharge, the intervention procedure will be stopped, but the collection of clinical and paraclinical data will be continued during the month following hospital discharge

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: VERONIQUE VIAL; Phone Number: 0033437915522; Email: veronique.vial@ch-le-vinatier.fr
• Study Contact Backup: Name: FLORELLE BERTRAND, PhD; Phone Number: 0033437915540; Email: florelle.bertrand@ch-le-vinatier.fr

Study Locations

• France
  • Auvergne-Rhône-Alpes
    • Bron, Auvergne-Rhône-Alpes, France, 69678 cedex
      • Centre Hospitalier le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cyan light therapy; Cyan light therapy involves the use of a medical device (usually a light-emitting diode, or LED) that emits cyan light, which is thought to stimulate the melanopsin-containing cells in the retina, in the same way as daylight.	Device: Medical light therapy device; The light therapy used in this study will be the DAYVIA SUNACTIV 2® glasses. This medical device with CE marking, emits a safe cyan light peaked at 500 nm and intensity of 1200 lux (Maximum intensity mode) allowing melanopic efficiency of 361,91 μW/cm². Only one mode is allowed to prevent the patient from changing the setting: 30 minutes sessions with an intensity of 1200 lux. At the end of a session the glasses start flashing for 3 seconds to indicate that it is over and then automatically turn off. The placebo is an attenuated model with a yellow wave length (600nm) and a very low intensity (33 lux) unable to activate the photoreceptors and therefore devoid of psychotropic or hypnotic effect.; Other Names: Dayvia Sunactiv-2
Sham Comparator: Sham light therapy; The comparison procedure will use the same model of medical device (DAYVIA SUNACTIV-2®) with CE marking, but with an attenuated form of light, i.e., <50 lux without blue light (600nm) that is unable to activate melanopsin cells (see for example Chojnacka et al., 2016) and therefore devoid of psychotropic or hypnotic effect.	Device: Medical light therapy device sham; The placebo is an attenuated model with a yellow wave length (600nm) and a very low intensity (33 lux) unable to activate the photoreceptors and therefore devoid of psychotropic or hypnotic effect.; Other Names: Dayvia Sunactiv-2 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of cocaine-free days (PCFD) over the one-month follow-up	Both cocaine abstinence and reduced frequency of cocaine use, measured as fewer days of use per week, were associated with significant clinical benefits across psychological, family, employment, and legal domains	One month
Time taken before the first relapse	Use of cocaine, of any kind	One month
Proportion of continuous cocaine abstinent patients during the one-month follow-up period	Abstinence rate	One month

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: BENJAMIN ROLLAND, MD, PhD, Centre Hospitalier le Vinatier

Publications and helpful links

Helpful Links

• SUAL : Service Universitaire d'Addictologie de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Cocaine-Related Disorders
• Other Study ID Numbers: 2024-A01379-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No