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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ketamine
Drugsingle dose of ketamine (0.71mg/kg bodyweight i.v. over 40 minutes)
Placebo
Drugsingle dose of placebo (0.9% saline solution i.v. over 40 minutes)
real-time fMRI neurofeedback training
BehavioralReal-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.
sham real-time fMRI neurofeedback training
BehavioralSham 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.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: rt-fMRI NFT / PlaceboExperimental treatment 2 interventions
Group B: rt-fMRI NFT / KetamineExperimental treatment 2 interventions
Group C: sham NFT / PlaceboPlacebo comparator 2 interventions
Group D: sham NFT / KetamineExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Decrease in proportion of cocaine use days
Between-group comparison of proportion of cocaine use days measured with Time-Line Follow-Back questionnaire for cocaine use on follow-up visit (t3).
Time frame
Between 5 and 7 weeks after baseline (the first intervention visit)2
Changes in fMRI signal of neurofeedback training
Signal changes assessed with fMRI between the non-neurofeedback run 1 on Interention Visit I (t1) and run 3 on Intervention Visit II (t2).
Time frame
Between 1 and 2 weeks after baseline (the first neurofeedback training)3
Changes in accumbal glutamate levels
Baseline and acute accumbal glutamate levels assessed with 1H-MRS on Intervention Visit I (t1).
Time frame
Before and during infusion (same day)Secondary outcomes
1
Changes in urine cocaine and cocaine metabolites
Changes in cocaine and cocaine metabolites via urine analysis as objectified measure of cocaine use.
Time frame
Baseline (screening visit) up to 19 weeks later (Follow-up Visit)2
Cocaine craving
Changes in cocaine craving score assessed by the Obsessive Compulsive Cocaine Use Scale, ranging from 0 to 56, where higher scores indicate more problematic behavior and thoughts.
Time frame
From baseline (screening visit) until 38 weeks later (Follow-up Survey)3
Severity of cocaine use disorder
Changes in severity of cocaine use disorder assessed by the Obsessive Compulsive Cocaine Use Scale, ranging from 0 to 56, where higher scores indicate more problematic behavior and thoughts.
Time frame
From baseline (screening visit) until 38 weeks later (Follow-up Survey)4
Current motivation to change cocaine use behaviour
Changes in current motivation to change cocaine use behaviour assessed by an visual analogue scale ranging from 0 to 30 where higher scores indicate a higher motivation to change.
Time frame
From baseline (screening visit) until 38 weeks later (Follow-up Survey)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov