Cocaine Use DisorderPhase 2Co-BoostNCT06125054
Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction
A Phase 2 study testing Ketamine and real-time fMRI neurofeedback training in people with Cocaine Use Disorder and Cocaine Dependence, run by Dr. med. Marcus Herdener at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Use Disorder, Cocaine Dependence
- What is being tested?
- Ketamine and real-time fMRI neurofeedback training
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Feb 2024to Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Normal level of language comprehension (German or Swiss-German)
Who cannot join
- Current or lifetime psychotic disorders
- History of severe substance-induced psychosis
- Current or lifetime bipolar I or II disorders
- Current suicidality
- Previous suicide attempts during the last 2 years
- Current severe alcohol use disorder
Show all 27Show fewer
- Current severe cannabis use disorder
- Current moderate or severe stimulant use disorder (other than cocaine)
- Current moderate or severe benzodiazepine use disorder
- Current opioid use disorder
- First-degree relatives with psychotic disorders
- Beck Depression Inventory Score greater than 25
- Unmedicated or unstable hypertension
- Severe illness (e. g. myocardial ischemia or arrythmias, severe pulmonary secretions, glaucoma, congestive heart failure or angina, significant renal or hepatic impairment)
- Acute infection (e. g. pulmonary or upper respiratory tract infection)
- Insufficient treated or uncorrected hyperthyroidism
- Severe central nervous system related traumas or disorders (e. g. stroke, cerebral trauma with loss of consciousness over more than 24h, epilepsy)
- Increased intracranial pressure
- Medication directly affecting glutamate signaling (e. g. anticonvulsant medication)
- Any unstable psychoactive medication (no changes in compounds within last 4 weeks before start of study)
- Pregnancy or lactation
- Women of childbearing potential with no use of medically accepted contraceptive (e. g.
- condoms, contraceptive diaphragm, birth control pill, hormone injection, intrauterine device)
- BMI>35
- Allergy, hypersensitivity, or other adverse reaction to previous use of ketamine
- Contradictions to magnetic resonance imaging
- Concurrent participation in other clinical study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Psychiatric University Hospital Zurich, University of Zurich
Zurich, Canton of Zurich, 8032
Marcus Herdener, PD Dr. med., +41583845810, marcus.herdener@bli.uzh.ch
Etna Engeli, Dr., +41583842771, etna.engeli@bli.uzh.ch
About this study
Official title: Boosting and Guiding Neuroplasticity by Combining Ketamine with Neurofeedback-assisted Learning - Towards an Individualized and Integrated Pharmaco-psychotherapy for Cocaine Addiction
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.
Read the detailed description
Cocaine is the most frequently used stimulant worldwide, and its consumption rate in Europe indicates a continuing upward trend. Cocaine use is associated with great harms for affected individuals, their families, and the society. Unfortunately, until today no pharmacotherapy has been approved for the treatment of cocaine use disorder (CUD) due to lack of efficacy of tested compounds.
The investigators therefore propose, to use latest advancements in proton magnetic resonance spectroscopy (1H-MRS) and real time functional magnetic resonance imaging neurofeedback training (rt-fMRI NFT) to develop a neurobiologically informed experimental approach for an individualized and integrated pharmaco-psychotherapy that has the potential to open new avenues for the treatment of CUD, and in addition, to be transferable to other neuropsychiatric conditions.
To improve the efficacy of psychotherapeutic interventions in individuals with CUD, the investigators recently developed an rt-fMRI NFT paradigm based on reward imagery to specifically modify maladaptive reward sensitivity by self-regulating the brain's reward circuits.
Furthermore, using a 1H-MRS technique, the investigators recently demonstrated that a disturbed glutamate homeostasis in the nucleus accumbens (NAcc), an important hub in the brain's reward system, characterizes cue-induced craving in CUD. This indicates that urgently needed novel pharmacotherapies for addiction treatment should target the glutamatergic system.
Thus, to restore the glutamate homeostasis and to boost learning effect of the reward imagery training, the investigators propose to combine reward imagery rt- fMRI NFT with the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine, which has direct effects both on glutamatergic signaling and neuroplasticity and has shown therapeutic potential to reduce cocaine craving and cocaine us.
The investigators anticipate a) restoration of the glutamate homeostasis in the NAcc b) changes in maladaptive reward sensitivity resulting from rt-fMRI NFT and c) synergistic effects of the pharmacological and the psychotherapeutic effect due to the ketamine-induced neuroplasticity that might open a window of opportunity for imagery-based learning. The investigators hypothesize that these neurobiological adaptions induced by the described interventions underlie their therapeutic effects on cocaine craving and use.
The effects of ketamine and reward imagery rt-fMRI NFT in individuals with CUD will be tested in a randomized, placebo-controlled, double blind, parallel group study.
- Conditions
- Cocaine Use Disorder, Cocaine Dependence
- Being tested
- Ketamine, Placebo, real-time fMRI neurofeedback training, sham real-time fMRI neurofeedback training
- Keywords
- Cocaine, Cocaine Use, Ketamine, Reward Sensitivity, Glutamate, Placebo-controlled, Therapeutic effects, Mechanistic effects, Neurofeedback Training, realtime fMRI
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
single dose of ketamine (0.71mg/kg bodyweight i.v. over 40 minutes)
PlaceboDrug
Also called 0.9% saline solution
single dose of placebo (0.9% saline solution i.v. over 40 minutes)
real-time fMRI neurofeedback trainingBehavioural
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.
sham real-time fMRI neurofeedback trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| rt-fMRI NFT / Placebo | Experimental | Participants get real time neurofeedback based on an experimental regions' activity and receive a 0.9% saline solution (i.v.) over 40 minutes. Receives: Drug: Placebo; Behavioral: real-time fMRI neurofeedback training |
| rt-fMRI NFT / Ketamine | Experimental | Participants get real time neurofeedback based on an experimental regions' activity and receive 0.71mg ketamine (i.v.) per kilogram bodyweight. Receives: Drug: Ketamine; Behavioral: real-time fMRI neurofeedback training |
| sham NFT / Placebo | Placebo comparator | Participants get a real time neurofeedback based on a control regions' activity, which serves as a sham region and receive a 0.9% saline solution (i.v.) over 40 minutes. Receives: Drug: Placebo; Behavioral: sham real-time fMRI neurofeedback training |
| sham NFT / Ketamine | Experimental | Participants get a real time neurofeedback based on a control regions' activity, which serves as a sham region and receive 0.71mg ketamine (i.v.) per kilogram bodyweight. Receives: Drug: Ketamine; Behavioral: sham real-time fMRI neurofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Between 5 and 7 weeks after baseline (the first intervention visit)
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).
Measured: Between 1 and 2 weeks after baseline (the first neurofeedback training)
Changes in accumbal glutamate levels
Baseline and acute accumbal glutamate levels assessed with 1H-MRS on Intervention Visit I (t1).
Measured: Before and during infusion (same day)
Secondary outcomes (16)
Changes in urine cocaine and cocaine metabolites
Changes in cocaine and cocaine metabolites via urine analysis as objectified measure of cocaine use.
Measured: Baseline (screening visit) up to 19 weeks later (Follow-up Visit)
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.
Measured: From baseline (screening visit) until 38 weeks later (Follow-up Survey)
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.
Measured: From baseline (screening visit) until 38 weeks later (Follow-up Survey)
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.
Measured: From baseline (screening visit) until 38 weeks later (Follow-up Survey)
Hedonic capacity
Changes in hedonic capacity measured by the Trait Hedonic Capacity Scale, ranging from 16 to 80, where a higher score indicates a higher hedonic capacity.
Measured: From baseline (screening visit) until 38 weeks later (Follow-up Survey)
Experience of pleasure across different domains
Changes in the experience of pleasure across different domains assessed by the Domains of Pleasure Scale, ranging from 0 to 210 where a higher score indicates a higher experience of pleasure.
Measured: From baseline (screening visit) until 38 weeks later (Follow-up Survey)
Emotion regulation skills
Changes in emotion regulation skills measured with the Negative Mood Regulation expectancies Scale, ranging from 30 to 150 where higher scores indicate higher emotion regulation skills.
Measured: Baseline (screening visit) and up to 19 weeks later (Follow-up Visit)
Depressive symptoms
Changes in depressive symptoms measured with the Beck Depression Inventory. The scale ranges from 0 to 63 where higher scores indicate more severe depressive symptoms.
Measured: Baseline (screening visit), up to 14 weeks later (Intervention Visit II), and up to 19 weeks later (Follow-up Visit)
Perceived stress
Changes in perceived stress assessed with a subscale of the Stress \& Coping Inventory, ranging from 21 to 147 where higher scores indicate higher perceived stress.
Measured: Baseline (screening visit), up to 19 weeks later (Follow-up Visit), and up to 38 weeks later (Follow-up Survey)
Self-esteem
Changes in self-esteem assessed with the Rosenberg Self-esteem Scale, ranging from 0 to 30 where higher scores indicate a higher self-esteem.
Measured: Baseline (screening visit), up to 14 weeks later (Intervention Visit II), up to 19 weeks later (Follow-up Visit), and up to 38 weeks later (Follow-up Survey)
Self-efficacy, optimism, and pessimism
Changes in Self-efficacy, optimism, and pessimism assessed with the Questionnaire for Self-efficacy, Optimism, and Pessimism (KSWOP-9), ranging from 9 to 36 where higher scores indicate higher self-efficacy, optimism, and pessimism, respectively.
Measured: Baseline (screening visit), up to 14 weeks later (Intervention Visit II), up to 19 weeks later (Follow-up Visit), and up to 38 weeks later (Follow-up Survey)
Subjective effects of ketamine infusion
Assess the acute subjective effects of the infusion with the Five-Dimension Altered State of Consciousness Questionnaire (5D-ASC), where the global score and each of the 11 subscales range from 0 to 100 and higher scores indicate the occurence of altered states of consciousness.
Measured: 2 hours post infusion
Effects of ketamine infusion on mystic experiences
Assess the acute subjective effects of the infusion with the Hood's Mysticism Scale, ranging from 20 to 100 where higher scores indicate the occurence of mystic experiences.
Measured: 2 hours post infusion
Sustained changes in accumbal glutamate levels
Assess sustained effects of the infusion and the neurofeedback training on baseline accumbal glutamate levels with 1H-MRS.
Measured: Baseline (pre infusion, Intervention Visit I) and up to 2 weeks after infusion and neurofeedback training (Intervention Visit II)
Glutamate levels during craving paradigm
Assess the effects of the infusion and the neurofeedback training on glutamate levels measured by 1H-MRS during a craving paradigm.
Measured: Up to 2 weeks post infusion and neurofeedback training
Changes in Brain Derived Neurotrophic Factor
Assess changes in Brain Derived Neurotrophic Factor (BDNF) through blood analysis before and after the infusion.
Measured: 0.5 hours pre infusion and 2 hours post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start5 Feb 2024
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double blind, parallel group, single center study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. med. Marcus Herdener
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, University of Vienna, University of Campania Luigi Vanvitelli
- Responsible party
- Sponsor-investigator, Dr. med. Marcus Herdener, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125054
- Sponsor's protocol ID
- Co-Boost_PUK_2022-01859
- Acronym
- Co-Boost
- Status last verified
- Dec 2024
- First submitted
- 26 Oct 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our data will be published on the website of Open Science Framework.
Publications
Trippel AS, Gubser LP, Engeli EJE, Conradi J, Haugg A, Zoelch N, Herdener M. Co-Boost: boosting and guiding neuroplasticity by combining ketamine with neurofeedback-assisted learning-towards an individualised and integrated pharmaco-psychotherapy for cocaine addiction: study protocol for a randomised, placebo-controlled, double-blind, parallel-group, single-centre trial. Trials. 2025 Sep 25;26(1):354. doi: 10.1186/s13063-025-08982-9.
PubMed 40999531
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting and Guiding Neuroplasticity by Combining Ketamine with Neurofeedback-assisted Learning - Towards an Individualized and Integrated Pharmaco-psychotherapy for Cocaine Addiction
- ClinicalTrials.gov ID
- NCT06125054
- Acronym / sponsor ID
- Co-Boost / Co-Boost_PUK_2022-01859
- Conditions
- Cocaine Use Disorder, Cocaine Dependence
- Keywords
- Cocaine, Cocaine Use, Ketamine, Reward Sensitivity, Glutamate, Placebo-controlled, Therapeutic effects, Mechanistic effects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr. med. Marcus HerdenerUniversity, hospital or other
- Collaborators
- University of Zurich, University of Vienna, University of Campania Luigi Vanvitelli
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cocaine is the most frequently used stimulant worldwide, and its consumption rate in Europe indicates a continuing upward trend. Cocaine use is associated with great harms for affected individuals, their families, and the society. Unfortunately, until today no pharmacotherapy has been approved for the treatment of cocaine use disorder (CUD) due to lack of efficacy of tested compounds.
The investigators therefore propose, to use latest advancements in proton magnetic resonance spectroscopy (1H-MRS) and real time functional magnetic resonance imaging neurofeedback training (rt-fMRI NFT) to develop a neurobiologically informed experimental approach for an individualized and integrated pharmaco-psychotherapy that has the potential to open new avenues for the treatment of CUD, and in addition, to be transferable to other neuropsychiatric conditions.
To improve the efficacy of psychotherapeutic interventions in individuals with CUD, the investigators recently developed an rt-fMRI NFT paradigm based on reward imagery to specifically modify maladaptive reward sensitivity by self-regulating the brain's reward circuits.
Furthermore, using a 1H-MRS technique, the investigators recently demonstrated that a disturbed glutamate homeostasis in the nucleus accumbens (NAcc), an important hub in the brain's reward system, characterizes cue-induced craving in CUD. This indicates that urgently needed novel pharmacotherapies for addiction treatment should target the glutamatergic system.
Thus, to restore the glutamate homeostasis and to boost learning effect of the reward imagery training, the investigators propose to combine reward imagery rt- fMRI NFT with the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine, which has direct effects both on glutamatergic signaling and neuroplasticity and has shown therapeutic potential to reduce cocaine craving and cocaine us.
The investigators anticipate a) restoration of the glutamate homeostasis in the NAcc b) changes in maladaptive reward sensitivity resulting from rt-fMRI NFT and c) synergistic effects of the pharmacological and the psychotherapeutic effect due to the ketamine-induced neuroplasticity that might open a window of opportunity for imagery-based learning. The investigators hypothesize that these neurobiological adaptions induced by the described interventions underlie their therapeutic effects on cocaine craving and use.
The effects of ketamine and reward imagery rt-fMRI NFT in individuals with CUD will be tested in a randomized, placebo-controlled, double blind, parallel group study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, placebo-controlled, double blind, parallel group, single center study
| Arm | Type | Receives |
|---|---|---|
| rt-fMRI NFT / Placebo | Experimental | Drug: Placebo, Behavioral: real-time fMRI neurofeedback trainingParticipants get real time neurofeedback based on an experimental regions' activity and receive a 0.9% saline solution (i.v.) over 40 minutes. |
| rt-fMRI NFT / Ketamine | Experimental | Drug: Ketamine, Behavioral: real-time fMRI neurofeedback trainingParticipants get real time neurofeedback based on an experimental regions' activity and receive 0.71mg ketamine (i.v.) per kilogram bodyweight. |
| sham NFT / Placebo | Placebo comparator | Drug: Placebo, Behavioral: sham real-time fMRI neurofeedback trainingParticipants get a real time neurofeedback based on a control regions' activity, which serves as a sham region and receive a 0.9% saline solution (i.v.) over 40 minutes. |
| sham NFT / Ketamine | Experimental | Drug: Ketamine, Behavioral: sham real-time fMRI neurofeedback trainingParticipants get a real time neurofeedback based on a control regions' activity, which serves as a sham region and receive 0.71mg ketamine (i.v.) per kilogram bodyweight. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- Normal level of language comprehension (German or Swiss-German)
Key exclusion criteria (27 listed)
- Current or lifetime psychotic disorders
- History of severe substance-induced psychosis
- Current or lifetime bipolar I or II disorders
- Current suicidality
- Previous suicide attempts during the last 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketaminesingle dose of ketamine (0.71mg/kg bodyweight i.v. over 40 minutes) | Drug | rt-fMRI NFT / Ketamine, sham NFT / Ketamine |
| PlaceboAlso: 0.9% saline solutionsingle dose of placebo (0.9% saline solution i.v. over 40 minutes) | Drug | rt-fMRI NFT / Placebo, sham NFT / Placebo |
| real-time fMRI neurofeedback trainingReal-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. | Behavioural | rt-fMRI NFT / Ketamine, rt-fMRI NFT / Placebo |
| sham real-time fMRI neurofeedback trainingSham 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. | Behavioural | sham NFT / Ketamine, sham NFT / Placebo |
Primary outcome
Decrease in proportion of cocaine use days
Time frame: Between 5 and 7 weeks after baseline (the first intervention visit)
Between-group comparison of proportion of cocaine use days measured with Time-Line Follow-Back questionnaire for cocaine use on follow-up visit (t3).
Changes in fMRI signal of neurofeedback training
Time frame: Between 1 and 2 weeks after baseline (the first 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).
Changes in accumbal glutamate levels
Time frame: Before and during infusion (same day)
Baseline and acute accumbal glutamate levels assessed with 1H-MRS on Intervention Visit I (t1).
16 secondary outcomes
Changes in urine cocaine and cocaine metabolites
Time frame: Baseline (screening visit) up to 19 weeks later (Follow-up Visit)
Cocaine craving
Time frame: From baseline (screening visit) until 38 weeks later (Follow-up Survey)
Severity of cocaine use disorder
Time frame: From baseline (screening visit) until 38 weeks later (Follow-up Survey)
Current motivation to change cocaine use behaviour
Time frame: From baseline (screening visit) until 38 weeks later (Follow-up Survey)
Hedonic capacity
Time frame: From baseline (screening visit) until 38 weeks later (Follow-up Survey)
Experience of pleasure across different domains
Time frame: From baseline (screening visit) until 38 weeks later (Follow-up Survey)
Emotion regulation skills
Time frame: Baseline (screening visit) and up to 19 weeks later (Follow-up Visit)
Depressive symptoms
Time frame: Baseline (screening visit), up to 14 weeks later (Intervention Visit II), and up to 19 weeks later (Follow-up Visit)
Perceived stress
Time frame: Baseline (screening visit), up to 19 weeks later (Follow-up Visit), and up to 38 weeks later (Follow-up Survey)
Self-esteem
Time frame: Baseline (screening visit), up to 14 weeks later (Intervention Visit II), up to 19 weeks later (Follow-up Visit), and up to 38 weeks later (Follow-up Survey)
Self-efficacy, optimism, and pessimism
Time frame: Baseline (screening visit), up to 14 weeks later (Intervention Visit II), up to 19 weeks later (Follow-up Visit), and up to 38 weeks later (Follow-up Survey)
Subjective effects of ketamine infusion
Time frame: 2 hours post infusion
Effects of ketamine infusion on mystic experiences
Time frame: 2 hours post infusion
Sustained changes in accumbal glutamate levels
Time frame: Baseline (pre infusion, Intervention Visit I) and up to 2 weeks after infusion and neurofeedback training (Intervention Visit II)
Glutamate levels during craving paradigm
Time frame: Up to 2 weeks post infusion and neurofeedback training
Changes in Brain Derived Neurotrophic Factor
Time frame: 0.5 hours pre infusion and 2 hours post infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Derived from this study: PubMed 40999531Trippel AS, Gubser LP, Engeli EJE, Conradi J, Haugg A, Zoelch N, Herdener M. Co-Boost: boosting and guiding neuroplasticity by combining ketamine with neurofeedback-assisted learning-towards an individualised and integrated pharmaco-psychotherapy for cocaine addiction: study protocol for a randomised, placebo-controlled, double-blind, parallel-group, single-centre trial. Trials. 2025 Sep 25;26(1):354. doi: 10.1186/s13063-025-08982-9.
- Individual participant dataSharing planned: Yes. Our data will be published on the website of Open Science Framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and real-time fMRI neurofeedback training in people with Cocaine Use Disorder and Cocaine Dependence, run by Dr. med. Marcus Herdener at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus Herdener, PD Dr. med. (+41583845810, marcus.herdener@bli.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in proportion of cocaine use days (time frame: Between 5 and 7 weeks after baseline (the first intervention visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06125054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.