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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorDr. med. Marcus Herdener

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Current or lifetime psychotic disorders

History of severe substance-induced psychosis

Current or lifetime bipolar I or II disorders

Current suicidality

Trial design

Treatments tested in this trial

  • Ketamine
  • Placebo
  • real-time fMRI neurofeedback training
  • sham real-time fMRI neurofeedback training

Treatment groups

120 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Dr. med. Marcus Herdener

Lead sponsor

Psychiatric University Hospital, Zurich

Sponsor institution

University of Zurich

Collaborator

University of Vienna

Collaborator

University of Campania Luigi Vanvitelli

Collaborator