Cocaine Use DisorderCokeSoNCT07119567
Impact of Cocaine Use and Withdrawal on Sleep
An observational study of Cocaine Use Disorder, run by Hôpital le Vinatier at 3 sites in France.
Trial summary
This study investigates how cocaine use and withdrawal affect sleep and circadian rhythms in individuals undergoing inpatient detoxification. Using wearable sleep monitors, actigraphy, questionnaires, and hormonal biomarkers, it aims to capture both objective and subjective changes in sleep across three key stages… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Multimodal Sleep and Biomarker Assessment
- How many people
- 32 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Mar 2026to 31 Dec 2028
- Phase
- Observational
- 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
Study population: Patients with cocaine use disorder seeking hospitalization for withdrawal
Who may be able to join
- Male or female, aged 18 years or older
- Meeting DSM-5 criteria for cocaine use disorder
- Positive urine drug screen for cocaine
- Scheduled for inpatient supervised cocaine detoxification within the next four weeks
- Covered by a national health insurance plan or social security system
- Have a valid, personal means of contact (telephone or email address) enabling remote follow-up at 6 months.
Who cannot join
- Current diagnosis of opioid use disorder or other psychostimulant use disorders (e.g., amphetamines, methamphetamines, cathinones, methylphenidate)
- Unstable psychiatric disorder or somatic illness deemed incompatible with study participation by the investigator
- Current treatment with methylphenidate, modafinil, solriamfetol, melatonin, pitolisant, naltrexone, or bupropion
- Patients under legal guardianship
- Pregnant or breastfeeding women: a pregnancy test will be performed prior to inclusion for women of childbearing potential
- Individuals deprived of liberty by judicial or administrative decision
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Centre Hospitalier Le Vinatier
Bron, AURA, 69500
VERONIQUE VIAL, 0437915522, veronique.vial@ch-le-vinatier.fr
CORALIE PERROT, 0437915531, coralie.perrot@ch-le-vinatier.fr
- 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
- Recruiting
CH Le Vinatier
Bron, 69500
About this study
Official title: Longitudinal Exploration of Subjective and Objective Sleep Characteristics in Patients With Cocaine Use Disorder During the Withdrawal Process
This study investigates how cocaine use and withdrawal affect sleep and circadian rhythms in individuals undergoing inpatient detoxification. Using wearable sleep monitors, actigraphy, questionnaires, and hormonal biomarkers, it aims to capture both objective and subjective changes in sleep across three key stages: active use, early withdrawal, and late withdrawal. The study is unique in its ability to explore sleep microstructure, the circadian system's role via melatonin and cortisol measurements, and the dynamic relationship between subjective sleep perception and objective sleep data. It also examines whether sleep quality may serve as a predictive marker of long-term withdrawal success.
Read the detailed description
Sleep disturbances are a common but poorly understood feature of cocaine use disorder, and may play a critical role in both relapse vulnerability and treatment outcomes. This interventional study aims to explore objective and subjective sleep patterns, as well as circadian regulation, across three distinct phases: during active cocaine use, early withdrawal, and late withdrawal. Participants will be individuals scheduled for supervised inpatient detoxification.
The study employs a multimodal assessment strategy:
- Ambulatory polysomnography using the Somfit® device will allow analysis of both macro- and microstructure of sleep across two nights per visit.
- Actigraphy will be used to capture precise temporal dynamics of sleep-wake rhythm over the course of the study.
- Subjective measures will include validated self-report questionnaires on sleep quality, insomnia severity, sleepiness, fatigue, and sleep perception.
- Urinary biomarkers (free cortisol and 6-sulfatoxymelatonin, collected 5 times/day) will provide data on circadian rhythm integrity, enabling exploration of the role of circadian dysregulation in sleep disturbances.
A key originality of the study lies in its ability to dynamically assess the relationship between subjective and objective sleep parameters and to explore the circadian contribution to sleep disruption in cocaine users. Furthermore, by following patients through early and late withdrawal, the study will investigate whether sleep parameters could serve as predictive markers of long-term withdrawal success, offering potential targets for future therapeutic interventions.
- Conditions
- Cocaine Use Disorder
- Being tested
- Multimodal Sleep and Biomarker Assessment
- Keywords
- Cocaine use disorder, Withdrawal, Sleep, Polysomnography, Actimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Sleep and Biomarker AssessmentOther
Participants will undergo non-invasive sleep assessments including polysomnography recordings (using the Somfit® device), actigraphy, self-reported questionnaires (on sleep, substance use), and urinary biomarker collection (for cortisol and melatonin levels) at three distinct stages of their substance use/withdrawal timeline.
| Study group | Role | What they receive |
|---|---|---|
| Cocaine Use Disorder Group | A cohort of 32 patients with cocaine use disorder will undergo repeated sleep assessment at three key stages: during active use, at the beginning of withdrawal, and after a period of sustained withdrawal. All participants will serve as their own control across timepoints Receives: Other: Multimodal Sleep and Biomarker Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency (%) measured by polysomnography
Sleep efficiency, defined as the ratio of total sleep time to time spent in bed, will be assessed using the Somfit® wearable device. Measurements will be conducted over three visits corresponding to distinct stages of cocaine use and withdrawal: V1 (active use), V2 (early withdrawal), and V3 (late withdrawal). Each visit includes two consecutive nights of recording, and the 2 nights will be averaged for analysis purposes. This double recording also makes it possible to obtain data from one night if the second encounters a technical problem. The primary outcome will be derived from data collected over a 16-hour window encompassing the nocturnal sleep period.
Measured: 30 months
Secondary outcomes (6)
Objective Sleep Parameters measured by polysomnography
Objective sleep metrics including total sleep time (min), sleep onset latency (min), wake after sleep onset (WASO, min), REM sleep duration and latency, time spent in N1, N2, N3 stages (min and %), micro-arousal index, phasic/tonic REM proportions, spindle index in NREM sleep, and delta power during N3 will be recorded via polysomnography (SOMFIT) across three study visits (each comprising two nights of measurement).
Measured: 30 months
Sleep-Wake Rhythm Parameters from Actigraphy
Actigraphy data from the MotionWatch 8® will be used to assess weekly sleep-wake patterns. Extracted parameters include sleep onset and offset times, sleep midpoint, time in bed, total sleep time, sleep onset latency, WASO, sleep efficiency, and diurnal naps (presence, number, duration, and timing).
Measured: 30 months
Sleep-Wake Rhythm Parameters from Sleep Diary
Entries in the sleep diary will be used to assess weekly sleep-wake patterns
Measured: 30 months
Subjective Sleep Scores
Sleep-related self-reported outcomes will be assessed using the following validated questionnaires completed after polysomnography nights.
Measured: 30 months
Circadian Rhythmicity via Urinary Cortisol
Circadian rhythm will be evaluated by analyzing sequential urinary samples (5/24h) for free cortisol levels at two withdrawal phases: early withdrawal (Visit 2) and late withdrawal (Visit 3).
Measured: 30 months
Circadian Rhythmicity via Melatonin Metabolites
Circadian rhythm will be evaluated by analyzing sequential urinary samples (5/24h) for 6-sulfatoxymelatonin levels at two withdrawal phases: early withdrawal (Visit 2) and late withdrawal (Visit 3).
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start19 Mar 2026
- Primary completion15 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 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
- NCT07119567
- Sponsor's protocol ID
- 2025-A00292-47
- Acronym
- CokeSo
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Exploration of Subjective and Objective Sleep Characteristics in Patients With Cocaine Use Disorder During the Withdrawal Process
- ClinicalTrials.gov ID
- NCT07119567
- Acronym / sponsor ID
- CokeSo / 2025-A00292-47
- Conditions
- Cocaine Use Disorder
- Keywords
- Cocaine use disorder, Withdrawal, Sleep, Polysomnography, Actimetry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Aug 2025 (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.
This study investigates how cocaine use and withdrawal affect sleep and circadian rhythms in individuals undergoing inpatient detoxification. Using wearable sleep monitors, actigraphy, questionnaires, and hormonal biomarkers, it aims to capture both objective and subjective changes in sleep across three key stages: active use, early withdrawal, and late withdrawal. The study is unique in its ability to explore sleep microstructure, the circadian system's role via melatonin and cortisol measurements, and the dynamic relationship between subjective sleep perception and objective sleep data. It also examines whether sleep quality may serve as a predictive marker of long-term withdrawal success.
Detailed description
Sleep disturbances are a common but poorly understood feature of cocaine use disorder, and may play a critical role in both relapse vulnerability and treatment outcomes. This interventional study aims to explore objective and subjective sleep patterns, as well as circadian regulation, across three distinct phases: during active cocaine use, early withdrawal, and late withdrawal. Participants will be individuals scheduled for supervised inpatient detoxification.
The study employs a multimodal assessment strategy:
- Ambulatory polysomnography using the Somfit® device will allow analysis of both macro- and microstructure of sleep across two nights per visit.
- Actigraphy will be used to capture precise temporal dynamics of sleep-wake rhythm over the course of the study.
- Subjective measures will include validated self-report questionnaires on sleep quality, insomnia severity, sleepiness, fatigue, and sleep perception.
- Urinary biomarkers (free cortisol and 6-sulfatoxymelatonin, collected 5 times/day) will provide data on circadian rhythm integrity, enabling exploration of the role of circadian dysregulation in sleep disturbances.
A key originality of the study lies in its ability to dynamically assess the relationship between subjective and objective sleep parameters and to explore the circadian contribution to sleep disruption in cocaine users. Furthermore, by following patients through early and late withdrawal, the study will investigate whether sleep parameters could serve as predictive markers of long-term withdrawal success, offering potential targets for future therapeutic interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cocaine Use Disorder Group | – | Other: Multimodal Sleep and Biomarker AssessmentA cohort of 32 patients with cocaine use disorder will undergo repeated sleep assessment at three key stages: during active use, at the beginning of withdrawal, and after a period of sustained withdrawal. All participants will serve as their own control across timepoints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cocaine use disorder seeking hospitalization for withdrawal
Key inclusion criteria (6 listed)
- Male or female, aged 18 years or older
- Meeting DSM-5 criteria for cocaine use disorder
- Positive urine drug screen for cocaine
- Scheduled for inpatient supervised cocaine detoxification within the next four weeks
- Covered by a national health insurance plan or social security system
Key exclusion criteria (6 listed)
- Current diagnosis of opioid use disorder or other psychostimulant use disorders (e.g., amphetamines, methamphetamines, cathinones, methylphenidate)
- Unstable psychiatric disorder or somatic illness deemed incompatible with study participation by the investigator
- Current treatment with methylphenidate, modafinil, solriamfetol, melatonin, pitolisant, naltrexone, or bupropion
- Patients under legal guardianship
- Pregnant or breastfeeding women: a pregnancy test will be performed prior to inclusion for women of childbearing potential
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 |
|---|---|---|
| Multimodal Sleep and Biomarker AssessmentParticipants will undergo non-invasive sleep assessments including polysomnography recordings (using the Somfit® device), actigraphy, self-reported questionnaires (on sleep, substance use), and urinary biomarker collection (for cortisol and melatonin levels) at three distinct stages of their substance use/withdrawal timeline. | Other | Cocaine Use Disorder Group |
Primary outcome
Sleep Efficiency (%) measured by polysomnography
Time frame: 30 months
Sleep efficiency, defined as the ratio of total sleep time to time spent in bed, will be assessed using the Somfit® wearable device. Measurements will be conducted over three visits corresponding to distinct stages of cocaine use and withdrawal: V1 (active use), V2 (early withdrawal), and V3 (late withdrawal). Each visit includes two consecutive nights of recording, and the 2 nights will be averaged for analysis purposes. This double recording also makes it possible to obtain data from one night if the second encounters a technical problem. The primary outcome will be derived from data collected over a 16-hour window encompassing the nocturnal sleep period.
6 secondary outcomes
Objective Sleep Parameters measured by polysomnography
Time frame: 30 months
Sleep-Wake Rhythm Parameters from Actigraphy
Time frame: 30 months
Sleep-Wake Rhythm Parameters from Sleep Diary
Time frame: 30 months
Subjective Sleep Scores
Time frame: 30 months
Circadian Rhythmicity via Urinary Cortisol
Time frame: 30 months
Circadian Rhythmicity via Melatonin Metabolites
Time frame: 30 months
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 11 Jun 2026.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Use Disorder, run by Hôpital le Vinatier at 3 sites 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 6 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 11 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 3 sites 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. 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 ILONA MEDIGUE, PhD student (00334 37 91 55 65, ilona.medigue@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (%) measured by polysomnography (time frame: 30 months). 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 11 Jun 2026.