RecruitingNCT07119567

Impact of Cocaine Use and Withdrawal on Sleep

Longitudinal Exploration of Subjective and Objective Sleep Characteristics in Patients With Cocaine Use Disorder During the Withdrawal Process

Sponsor

Hôpital le Vinatier

Enrollment

32 participants

Start Date

Mar 19, 2026

Study Type

OBSERVATIONAL

Conditions

Cocaine Use Disorder

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria6

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

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Interventions

OTHERMultimodal Sleep and Biomarker Assessment

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.