Cocaine-Related Disorders
Conditions
Brief summary
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.
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
Interventions
DEVICEMedical 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.
DEVICEMedical 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.
Sponsors
Hôpital le Vinatier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Only the biostatistician in charge of producing the randomization list, and the pharmacy of the coordinating centers that will manage the conditioning, labeling, and shipping of the medical devices used by the different centers, will possess the information about which group a given participant belongs to.
Intervention model description
A multicenter double blind randomized clinical trial is the best design to demonstrate the efficacy of a medical device, such a light therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of cocaine-free days (PCFD) over the one-month follow-up | One month | 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 |
| Time taken before the first relapse | One month | Use of cocaine, of any kind |
| Proportion of continuous cocaine abstinent patients during the one-month follow-up period | One month | Abstinence rate |
Countries
France
Contacts
CONTACTFLORELLE BERTRAND, PhD
CONTACTVERONIQUE VIAL
PRINCIPAL_INVESTIGATORBENJAMIN ROLLAND, MD, PhD
Centre Hospitalier le Vinatier
Outcome results
None listed