Actively Recruiting

Phase 2
Age: 18Years - 55Years
All Genders
ID06125054

Ketamine Combined with Real-time fMRI Neurofeedback Training to Study Brain Changes and Cocaine Use in Cocaine Addiction

Led by Dr. med. Marcus Herdener · Updated on 2024-12-20

120

Participants Needed

1

Research Sites

107 weeks

Total Duration

On this page

Sponsors

D

Dr. med. Marcus Herdener

Lead Sponsor

U

University of Zurich

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of combining ketamine with real-time functional magnetic resonance imaging (fMRI) neurofeedback training in adults with cocaine use disorder. This Phase 2 trial aims to explore whether the combination or individual interventions can reduce the percentage of days participants use cocaine. The study also investigates if neurofeedback training has lasting effects and if ketamine influences glutamate levels in a key brain area related to reward. Participants receive either a single intravenous dose of ketamine or a placebo saline solution over 40 minutes. They also undergo real-time fMRI neurofeedback training or a sham version, where they perform reward imagery tasks during 20-minute sessions repeated three times. The study compares four groups to assess the effects of each intervention alone and in combination. During the study, researchers monitor cocaine use days between weeks 5 and 7 after the first intervention visit. Brain scans measure changes in neurofeedback signals within 1 to 2 weeks after neurofeedback training and glutamate levels before and during ketamine or placebo infusion. Safety and effects are observed through these imaging techniques and participant reports throughout the study period.

CONDITIONS

Official Title

Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Male and female cocaine users aged 18 to 55 years
  • Diagnosis of cocaine use disorder according to DSM-5
  • Willingness to follow the study protocol
  • Normal understanding of German or Swiss-German language
Not Eligible

You will not qualify if you...

  • Current or past psychotic disorders
  • History of severe substance-induced psychosis
  • Current or past bipolar I or II disorder
  • Current suicidal thoughts or recent suicide attempts (within last 2 years)
  • Severe alcohol or cannabis use disorder
  • Moderate or severe stimulant use disorder other than cocaine
  • Moderate or severe benzodiazepine use disorder
  • Opioid use disorder
  • First-degree relatives with psychotic disorders
  • Beck Depression Inventory score above 25
  • Unmedicated or unstable high blood pressure
  • Severe illnesses like heart, lung, kidney, liver problems, glaucoma, or congestive heart failure
  • Acute infections such as respiratory infections
  • Untreated or poorly managed hyperthyroidism
  • Severe brain injuries or disorders like stroke, epilepsy, or increased brain pressure
  • Medications affecting glutamate signaling or unstable psychoactive medications
  • Pregnancy or breastfeeding
  • Women of childbearing potential not using medically accepted contraception
  • Body mass index over 35
  • Allergy or sensitivity to ketamine
  • Contraindications to MRI
  • Participation in another clinical study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Psychiatric University Hospital Zurich, University of Zurich

Zurich, Canton of Zurich, Switzerland, 8032

Actively Recruiting

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Research Team

M

Marcus Herdener, PD Dr. med.

E

Etna Engeli, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Co-Boost: boosting and guiding neuroplasticity by combining ketamine with neurofeedback-assisted learning-towards an individualised and integrated pharmaco-psychotherapy for cocaine addiction: study protocol for a randomised, placebo-controlled, double-blind, parallel-group, single-centre trial.

Anna S Trippel, Ladina P Gubser, Etna J E Engeli...

https://pubmed.ncbi.nlm.nih.gov/40999531