not applicable social anxiety symptoms
Conditions
Interventions
Subjects will receive either psilocybin (15 mg) or placebo, coupled with either 
attention bias modification training (ABMT) or control training. A subset of 
subjects will further receive either neurofeedback training or control 
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a participant must meet all the following criteria: * >=35 on the Liebowitz Social Anxiety Scale * Previous experience with a psychedelic drug, but not within the past 1 month. * Age between 18 and 40 years * Free from psychotropic medication * Good physical health as determined by medical examination and laboratory analysis * Absence of any major medical, endocrine and neurological condition as determined by medical examination and laboratory analysis * Normal weight, body mass index (weight/height2) between 18 and 28 kg/m2 * Written Informed Consent * Good knowledge and understanding of the English language * Participants must be willing to refrain from taking illicit psychoactive substances during the study. * Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study day. * Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after substance administration.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * History of drug addiction (determined by the medical questionnaire, drug questionnaire and medical examination) * Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks) * Pregnancy or lactation or pregnancy planned during study participation * Hypertension (diastolic > 90 mmHg; systolic > 140 mmHg) * Current psychiatric disorder or history of depression or anxiety within the previous 24 months or clinically relevant impairment from Attention Deficit Hyperactivity Disorder (determined by the medical questionnaire and medical examination) * Current presence or history of psychosis in first-degree relatives * Any chronic or acute medical condition * History of cardiac dysfunctions (arrhythmia, ischemic heart disease,*) * Tobacco smoking (>20 per day) * Excessive drinking (>20 alcoholic consumptions per week) * Current use of SSRI medication * For women: no use of a reliable contraceptive * For a subset of participants: fMRI contraindications (pacemakers, metal implants, claustrophobia, permanent eye makeup)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter are changes in negative attention biases, when comparing the 6 different treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters include changes in subjective ratings of (social) anxiety and psychological wellbeing, and changes in blood and saliva concentrations of BDNF. Tertiary parameters include changes in brain activity (changes in the Blood-oxygen-level-dependent BOLD response and changes in glutamate concentrations) in the subset of individuals who undergo neurofeedback. Tertiary endpoints will also include factors which may influence the effect of psilocybin on attention biases and/or psychological outcomes, including psilocybin drug concentrations, inflammatory markers, and cortisol in blood, subjective drug effects, interpretation of ambiguous stimuli, autobiographical memory, cognitive flexibility and attentional control. | — |
Countries
Netherlands
Contacts
Public ContactNL Mason
Universiteit Maastricht
Outcome results
None listed