Actively Recruiting
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
Eligibility Criteria
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
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
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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