Impact of Cocaine Use and Withdrawal on Sleep

NCT07119567 | Recruiting

• 1 other identifier: 2025-A00292-47
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Cocaine Use Disorder

Keywords

Cocaine use disorder; Withdrawal; Sleep; Polysomnography; Actimetry

Outcome Measures

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.

  30 months

Secondary Outcomes (6)

• Objective Sleep Parameters measured by polysomnography

  30 months

• Sleep-Wake Rhythm Parameters from Actigraphy

  30 months

• Sleep-Wake Rhythm Parameters from Sleep Diary

  30 months

• Subjective Sleep Scores

  30 months

• Circadian Rhythmicity via Urinary Cortisol

  30 months

Study Arms (1)

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

Other: Multimodal Sleep and Biomarker Assessment

Interventions

Multimodal Sleep and Biomarker Assessment OTHER

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.

Cocaine Use Disorder Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cocaine use disorder seeking hospitalization for withdrawal

You may qualify if:

• 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.

You may not qualify if:

• 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
• Individuals deprived of liberty by judicial or administrative decision

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (3)

Centre Hospitalier Le Vinatier

Bron, AURA, 69500, France

NOT YET RECRUITING

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678 cedex, France

RECRUITING

CH Le Vinatier

Bron, 69500, France

RECRUITING

Study Officials

• BENJAMIN ROLLAND, MD, PhD

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ILONA MEDIGUE, PhD student

CONTACT

00334 37 91 55 65; ilona.medigue@ch-le-vinatier.fr

VERONIQUE VIAL, PM

CONTACT

00334 37 91 55 22; veronique.vial@ch-le-vinatier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 13, 2025
• Study Start: March 19, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (3)