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

Hôpital le Vinatier

Status: Begins enrollment in 3 months

Conditions: Cocaine-Related Disorders

Treatments: Device: Medical light therapy device; Device: Medical light therapy device sham

Study type: Interventional

Funder types: Other

Identifiers

NCT07545798

2024-A01379-38

Details and patient eligibility

About

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.

Full 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

Enrollment: 256 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups

Cyan light therapy

Active Comparator group

Description:

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.

Treatment:

Device: Medical light therapy device

Sham light therapy

Sham Comparator group

Description:

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.

Treatment:

Device: Medical light therapy device sham