Clinical TrialSubstance Use Disorders (SUD)PlaceboKetaminePlaceboKetamineRecruiting

Ketamine and Neurofeedback-Training: Effects on Neuroplasticity in Cocaine Addiction (Co-Boost)

This placebo-controlled, double-blind, parallel-group interventional trial (n=120) aims to explore the effects of combining ketamine with real-time functional magnetic resonance imaging (fMRI) neurofeedback training in individuals with cocaine use disorder (CUD).

Target Enrollment
120 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, placebo-controlled, double-blind, parallel-group single-centre study testing ketamine versus saline and active versus sham rt-fMRI neurofeedback in people with cocaine use disorder.

Participants receive a single i.v. infusion of ketamine (0.71 mg/kg over 40 minutes) or saline and undergo real-time fMRI neurofeedback or sham training (20-minute runs repeated three times).

Outcomes include percentage of cocaine use days, transfer effects of neurofeedback, and ketamine-dependent changes in nucleus accumbens glutamate measured by 1H-MRS; safety and tolerability also assessed.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

rt-fMRI NFT / Placebo

experimental

Realtime fMRI neurofeedback (experimental region) + i.v. placebo (0.9% saline) over 40 minutes.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    0.9% saline i.v. over 40 minutes

  • Compound
    via Other• three sessions

    Real-time fMRI neurofeedback (reward imagery), 20 minutes per run, repeated three times; feedback from experimental region

rt-fMRI NFT / Ketamine

experimental

Realtime fMRI neurofeedback (experimental region) + ketamine i.v. 0.71 mg/kg over 40 minutes.

Interventions

  • Ketamine0.71 mg/kg
    via IV• single dose• 1 doses total

    0.71 mg/kg i.v. infusion over 40 minutes

  • Compound
    via Other• three sessions

    Real-time fMRI neurofeedback (reward imagery), 20 minutes per run, repeated three times; feedback from experimental region

sham NFT / Placebo

inactive

Sham neurofeedback (control region) + i.v. placebo (0.9% saline) over 40 minutes.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    0.9% saline i.v. over 40 minutes

  • Compound
    via Other• three sessions

    Sham real-time fMRI neurofeedback (control region), 20 minutes per run, repeated three times

sham NFT / Ketamine

experimental

Sham neurofeedback (control region) + ketamine i.v. 0.71 mg/kg over 40 minutes.

Interventions

  • Ketamine0.71 mg/kg
    via IV• single dose• 1 doses total

    0.71 mg/kg i.v. infusion over 40 minutes

  • Compound
    via Other• three sessions

    Sham real-time fMRI neurofeedback (control region), 20 minutes per run, repeated three times

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 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)

Exclusion Criteria

  • Exclusion Criteria:
  • 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
  • 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

Study Details

Locations

Psychiatric University Hospital Zurich, University of Zurich — Zurich, Canton of Zurich, Switzerland

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