NCT07119567 Impact of Cocaine Use and Withdrawal on Sleep
| NCT ID | NCT07119567 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hôpital le Vinatier |
| Condition | Cocaine Use Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2028-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 32 participants in total. It began in 2026-03-19 with a primary completion date of 2028-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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: 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
BENJAMIN ROLLAND, MD, PhD
PRINCIPAL INVESTIGATOR
Centre Hospitalier le Vinatier
Frequently Asked Questions
Who can join the NCT07119567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cocaine Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07119567 currently recruiting?
Yes, NCT07119567 is actively recruiting participants. Contact the research team at ilona.medigue@ch-le-vinatier.fr for enrollment information.
Where is the NCT07119567 trial being conducted?
This trial is being conducted at Bron, France, Bron, France, Bron, France.
Who is sponsoring the NCT07119567 clinical trial?
NCT07119567 is sponsored by Hôpital le Vinatier. The principal investigator is BENJAMIN ROLLAND, MD, PhD at Centre Hospitalier le Vinatier. The trial plans to enroll 32 participants.