Actively Recruiting

Phase 2
Age: 18Years - 55Years
All Genders
NCT06125054

Ketamine and Neurofeedback-Training: Effects on Neuroplasticity 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

The goal of this clinical trial is to learn about the effects of the combination of ketamine and realtime functional magnetic resonance imaging (fMRI) neurofeedback training in individuals with cocaine use disorder. The main questions the investigators aim to answer are: * Can the investigators observe a positive, significant effect on percentage of cocaine use days of both interventions combined as well as stand alone interventions? * Is there a significant transfer effect of the neurofeedback training? * Is there a significant, ketamine-dependent change in glutamate levels in the nucleus accumbens? Participants will be given ketamine and a realtime fMRI neurofeedback training. Both interventions are placebo-controlled. The investigators will compare the four intervention groups to investigate the effects of the stand-alone effects of the intervention and the combination of it.

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

AI-Powered 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.

CONTACT

E

Etna Engeli, Dr.

CONTACT

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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