How cocaine use and stopping affects sleep and daily rhythms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier Le Vinatier
  Bron, Auvergne-Rhône-Alpes, France Recruiting
• CH Le Vinatier
  Bron, France Recruiting
• Centre Hospitalier Le Vinatier
  Bron, Aura, France Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HD-tDCS during CBT for Cocaine Use Disorder

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• Mild electrical brain stimulation (tDCS) with cognitive training to reduce cocaine cravings.

  This trial will test whether brief sessions of mild electrical brain stimulation (tDCS) combined with cognitive reappraisal training can lower craving in adults receiving inpatient treatment for cocaine use disorder.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT07318480

• Clonidine to reduce craving in hospitalized people with cocaine or crack use disorder

  This will try clonidine versus clonazepam to see if clonidine lowers craving in people hospitalized for cocaine or crack use disorder.

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• Semaglutide plus cognitive behavioral therapy for cocaine use disorder

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  Recruiting Phase 2 The University of Texas Health Science Center, Houston · Houston, Texas · NCT07227948

• Cue-reactivity incubation and cognitive reappraisal in cocaine use disorder

  This project will see if practicing cognitive reappraisal reduces cue-triggered brain responses and cravings in people with cocaine use disorder who are early in abstinence.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT07091877

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.