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

NCT07545798 | Not Yet Recruiting

• 1 other identifier: 2024-A01379-38
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine-Related Disorders

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Cyan light therapy

ACTIVE COMPARATOR

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

Sham light therapy

SHAM COMPARATOR

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

Interventions

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.

Also known as: Dayvia Sunactiv-2

Cyan light therapy

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.

Also known as: Dayvia Sunactiv-2 placebo

Sham light therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-stabilized opioid use disorder or other psychostimulant use disorder (e.g., amphetamine, met-amphetamine, cathinones, methylphenidate…)
• 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
• Persons deprived of their liberty by a judicial or administrative decision

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678 cedex, France

Location

Related Links

• SUAL : Service Universitaire d'Addictologie de Lyon

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• BENJAMIN ROLLAND, MD, PhD

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FLORELLE BERTRAND, PhD

CONTACT

0033437915540; florelle.bertrand@ch-le-vinatier.fr

VERONIQUE VIAL

CONTACT

0033437915522; veronique.vial@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter double blind randomized clinical trial is the best design to demonstrate the efficacy of a medical device, such a light therapy

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)