How cocaine use and stopping affects sleep and daily rhythms
Longitudinal Exploration of Subjective and Objective Sleep Characteristics in Patients With Cocaine Use Disorder During the Withdrawal Process
This study tries to see how cocaine use and stopping change sleep and circadian rhythms in adults entering supervised inpatient detoxification.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hôpital le Vinatier Academic / other |
| Locations | 3 sites (Bron, AURA and 2 other locations) |
| Trial ID | NCT07119567 on ClinicalTrials.gov |
What this trial studies
This observational study follows people with cocaine use disorder through three phases: active use, early withdrawal, and late withdrawal during supervised inpatient detoxification. It uses ambulatory polysomnography (Somfit®) over two nights per visit, continuous actigraphy, repeated sleep questionnaires, and frequent urinary biomarkers (free cortisol and 6-sulfatoxymelatonin) to capture objective and subjective sleep and circadian measures. The design permits analysis of sleep macro- and microstructure, the integrity of the circadian system, and day-to-day sleep–wake timing. By linking these multimodal measures, the study aims to explore whether sleep changes predict longer-term withdrawal outcomes.
Who should consider this trial
Good fit: Adults (18+) who meet DSM-5 criteria for cocaine use disorder, have a positive urine test for cocaine, and are scheduled for supervised inpatient detoxification within the next four weeks with valid contact information and national health coverage.
Not a fit: People with current opioid or other psychostimulant use disorders, unstable psychiatric or medical conditions, those taking certain medications (e.g., methylphenidate, modafinil, melatonin, naltrexone, bupropion), pregnant or breastfeeding women, or patients under legal guardianship are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, the results could identify sleep or circadian markers that help target interventions and reduce relapse risk during recovery from cocaine dependence.
How similar studies have performed: Previous work has used actigraphy and polysomnography in substance use disorders, but detailed monitoring of sleep microstructure and circadian biomarkers specifically across cocaine withdrawal phases is relatively novel with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bron, AURA and 2 other locations
- Centre Hospitalier Le Vinatier — Bron, Aura, France (Not_yet_recruiting)
- Centre Hospitalier Le Vinatier — Bron, Auvergne-Rhône-Alpes, France (Recruiting)
- CH Le Vinatier — Bron, France (Recruiting)
Study contacts
- Principal investigator: BENJAMIN ROLLAND, MD, PhD — Centre Hospitalier le Vinatier
- Study coordinator: ILONA MEDIGUE, PhD student
- Email: ilona.medigue@ch-le-vinatier.fr
- Phone: 00334 37 91 55 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.