Bright Light Therapy During Inpatient Cocaine Detoxification

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital le Vinatier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medical light therapy device

    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.

  • Medical light therapy device sham

    Device

    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.

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: Cyan light therapyActive comparator 1 intervention
Group B: Sham light therapySham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
One month
2

Time taken before the first relapse

Use of cocaine, of any kind

Time frame
One month
3

Proportion of continuous cocaine abstinent patients during the one-month follow-up period

Abstinence rate

Time frame
One month

Secondary outcomes

Other outcomes

Sponsors and contacts

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