Health TrialsbyHealthPanel

Impact of Cocaine Use and Withdrawal on Sleep

ConditionCocaine Use Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital le Vinatier

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with cocaine use disorder seeking hospitalization for withdrawal

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Multimodal Sleep and Biomarker Assessment

    Other intervention

    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.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Cocaine Use Disorder Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
30 months

Secondary outcomes

1

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).

Time frame
30 months
2

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).

Time frame
30 months
3

Sleep-Wake Rhythm Parameters from Sleep Diary

Entries in the sleep diary will be used to assess weekly sleep-wake patterns

Time frame
30 months
4

Subjective Sleep Scores

Sleep-related self-reported outcomes will be assessed using the following validated questionnaires completed after polysomnography nights.

Time frame
30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hôpital le Vinatier

Lead sponsor

Source ClinicalTrials.gov
Apply now