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

Summary

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

• Cocaine Use Disorder
• Cocaine Dependence

Interventions

DRUG

Ketamine

single dose of ketamine (0.71mg/kg bodyweight i.v. over 40 minutes)

DRUG

Placebo

single dose of placebo (0.9% saline solution i.v. over 40 minutes)

BEHAVIORAL

real-time fMRI neurofeedback training

Real-time fMRI based neurofeedback over 20 minutes where participants are instructed to perform reward imagery. The feedback is based on an experimental region. The training is repeated three times.

BEHAVIORAL

sham real-time fMRI neurofeedback training

Sham real-time fMRI neurofeedback training over 20 minutes where participants are instructed to perform reward imagery. The feedback is based on a control region. The training is repeated three times.

Sponsors & Collaborators

• University of Zurich

  collaborator OTHER

• University of Vienna

  collaborator OTHER

• University of Campania Luigi Vanvitelli

  collaborator OTHER

• Dr. med. Marcus Herdener

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-05

Primary Completion

2025-12-31

Completion

2026-03-31

Countries

• Switzerland

Study Locations