Effects of ketamine and neurofeedback on cocaine addiction

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 clinical trial investigates the combined effects of ketamine and real-time functional magnetic resonance imaging (fMRI) neurofeedback training on individuals with cocaine use disorder. Participants will be assigned to one of four groups receiving either the combination of interventions or placebo treatments, allowing researchers to assess the efficacy of each approach. The study aims to measure changes in cocaine use days, the transfer effects of neurofeedback training, and alterations in glutamate levels in the nucleus accumbens. This innovative approach seeks to develop a new treatment paradigm for cocaine addiction by targeting the brain's reward system.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Informed Consent as documented by signature
* Male and female cocaine users 18 to 55 years of age
* diagnostic and statisical manual (DSM)-5 diagnosis of CUD
* Willingness to comply with the study protocol as explained by investigator
* Normal level of language comprehension (German or Swiss-German)

Exclusion Criteria:

* Current or lifetime psychotic disorders
* History of severe substance-induced psychosis
* Current or lifetime bipolar I or II disorders
* Current suicidality
* Previous suicide attempts during the last 2 years
* Current severe alcohol use disorder
* Current severe cannabis use disorder
* Current moderate or severe stimulant use disorder (other than cocaine)
* Current moderate or severe benzodiazepine use disorder
* Current opioid use disorder
* First-degree relatives with psychotic disorders
* Beck Depression Inventory Score greater than 25
* Unmedicated or unstable hypertension
* Severe illness (e. g. myocardial ischemia or arrythmias, severe pulmonary secretions, glaucoma, congestive heart failure or angina, significant renal or hepatic impairment)
* Acute infection (e. g. pulmonary or upper respiratory tract infection)
* Insufficient treated or uncorrected hyperthyroidism
* Severe central nervous system related traumas or disorders (e. g. stroke, cerebral trauma with loss of consciousness over more than 24h, epilepsy)
* Increased intracranial pressure
* Medication directly affecting glutamate signaling (e. g. anticonvulsant medication)
* Any unstable psychoactive medication (no changes in compounds within last 4 weeks before start of study)
* Pregnancy or lactation
* Women of childbearing potential with no use of medically accepted contraceptive (e. g.

condoms, contraceptive diaphragm, birth control pill, hormone injection, intrauterine device)

* BMI\>35
* Allergy, hypersensitivity, or other adverse reaction to previous use of ketamine
* Contradictions to magnetic resonance imaging
* Concurrent participation in other clinical study

Where it's running

• Psychiatric University Hospital Zurich, University of Zurich
  Zurich, Canton of Zurich, Switzerland Recruiting

Study contacts

• Study coordinator: Marcus Herdener, PD Dr. med.
• Email: marcus.herdener@bli.uzh.ch
• Phone: +41583845810

Similar studies

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

• 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

• rTMS plus cognitive-behavioral therapy for cocaine use disorder

  This study tests whether adding rapid magnetic brain stimulation to standard CBT helps people with cocaine use disorder reduce use and improve brain connectivity.

  Recruiting New York State Psychiatric Institute · New York, New York · NCT05974202

• HD-tDCS during CBT for Cocaine Use Disorder

  This study tests whether adding high-definition transcranial direct current stimulation to cognitive behavioral therapy helps adults with cocaine use disorder see if CBT works better.

  Recruiting Virginia Commonwealth University · Richmond, Virginia · NCT07829263

• Imaging Brain Mitochondrial Complex-I in Cocaine Use Disorder

  This study uses a PET scan with [F-18]BCPP-EF to see how mitochondrial Complex-I activity in the brain differs between people with cocaine use disorder and healthy controls.

  Recruiting Early Phase 1 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07773649

• 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.

  Recruiting Phase 4 University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07313371

• Semaglutide plus cognitive behavioral therapy for cocaine use disorder

  This trial will test whether adding semaglutide (a GLP-1 medication) to cognitive behavioral therapy helps adults with cocaine use disorder reduce craving and use.

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

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.