Cocaine-Related DisordersCOKELUXNCT07545798
Bright Light Therapy During Inpatient Cocaine Detoxification
A study testing Medical light therapy device in people with Cocaine-Related Disorders, run by Hôpital le Vinatier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Medical light therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2025to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Le Vinatier
Bron, Auvergne-Rhône-Alpes, 69678 cedex
ROLLAND BENJAMIN, MD,Ph, 0033 437 915 555, benjamin.rolland@ch-le-vinatier.fr
VIAL VERONIQUE, 0033 437 915 531, veronique.vial@ch-le-vinatier.fr
About this study
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.
Read the 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
- Conditions
- Cocaine-Related Disorders
- Being tested
- Medical light therapy device, Medical light therapy device sham
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical light therapy deviceDevice
Also called Dayvia Sunactiv-2
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 shamDevice
Also called Dayvia Sunactiv-2 placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Medical light therapy device sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month
Time taken before the first relapse
Use of cocaine, of any kind
Measured: One month
Proportion of continuous cocaine abstinent patients during the one-month follow-up period
Abstinence rate
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start12 Sep 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BENJAMIN ROLLAND, MD, PhD, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545798
- Sponsor's protocol ID
- 2024-A01379-38
- Acronym
- COKELUX
- Status last verified
- Jun 2026
- First submitted
- 16 Apr 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy During Inpatient Cocaine Detoxification
- ClinicalTrials.gov ID
- NCT07545798
- Acronym / sponsor ID
- COKELUX / 2024-A01379-38
- Conditions
- Cocaine-Related Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Cyan light therapy | Active comparator | Device: Medical light therapy deviceCyan 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. |
| Sham light therapy | Sham comparator | Device: Medical light therapy device shamThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical light therapy deviceAlso: Dayvia Sunactiv-2The 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. | Device | Cyan light therapy |
| Medical light therapy device shamAlso: Dayvia Sunactiv-2 placeboThe 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. | Device | Sham light therapy |
Primary outcome
Percentage of cocaine-free days (PCFD) over the one-month follow-up
Time frame: 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
Time frame: One month
Use of cocaine, of any kind
Proportion of continuous cocaine abstinent patients during the one-month follow-up period
Time frame: One month
Abstinence rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- SUAL : Service Universitaire d'Addictologie de LyonLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BENJAMIN ROLLAND, MD, PhD principal investigator
Centre Hospitalier le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical light therapy device in people with Cocaine-Related Disorders, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FLORELLE BERTRAND, PhD (0033437915540, florelle.bertrand@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of cocaine-free days (PCFD) over the one-month follow-up (time frame: One month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.