Psilocybin-assisted psychotherapy for Generalised Anxiety Disorder
Safety and efficacy of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder [Psi-GAD-1]: a randomised triple-blind active-placebo-controlled trial
Monash University
72 participants
May 2, 2022
Interventional
Conditions
Summary
Psilocybin-assisted psychotherapy has demonstrated excellent safety and efficacy in the treatment of depression, substance use disorders, and mental ill-health related to terminal illness. Many patients in these trials have reported rapid, large, and persistent decreases in symptoms of anxiety, suggesting utility in treating anxiety disorders with psilocybin-assisted psychotherapy. However, the impact of this treatment for people with GAD is unknown. In this study, we will complete a randomised controlled trial to test a 7 week (2 dose) psilocybin-assisted psychotherapy for the treatment of GAD. 72 individuals will be randomly assigned to receive two doses either psilocybin (25mg or 30mg, oral) or placebo (diphenhydramine, 75mg or 100mg, oral) with three weeks between doses. All participants will receive psychotherapy before, during, and after dosing sessions. A variety of measures will test for safety and efficacy of the treatment. The primary outcome measure investigates change in clinician-rated symptoms of anxiety. A range of secondary and exploratory measures probe changes in disability, quality of life, comorbid psychiatric and addictive symptoms, baseline and acute predictors, as well as participant-rated acceptability, appropriateness and feasibility of the treatment.
Eligibility
Inclusion Criteria5
- Adults experiencing severe GAD.
- Proficiency in English.
- Provide a contact (relative, spouse, close friend or other Support Person) who can transport and provide support to participant following two or three experimental sessions.
- Taper and cease of certain excluded medications is deemed appropriate, agreeable, and under supportive care, and successful following confirmation of preliminary enrolment. Note, prospective participants are not required to taper and cease prior to preliminary enrolment.
- Agree to all study-related requirements.
Exclusion Criteria6
- Contraindicated medical conditions including cardiovascular conditions, major CNS disease, hepatic dysfunction, hypercalcaemia risk, epilepsy/seizures, renal insufficiency, diabetes, and hypothyroidism.
- Weigh less than 48 kilograms or BMI < 17.
- Are pregnant or nursing, or able to become pregnant and are not practicing permanent or double-barrier birth control methods.
- Taking a contraindicated medication that cannot be ceased for an appropriate length of time during the trial.
- Extremely severe depression, anxiety, suicidality or other psychiatric symptoms that would warrant hospitalisation, as determined by the screening psychiatrist in a clinical interview.
- Current or past history of meeting DSM-5 criteria for certain excluded psychiatric indications.
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Interventions
Psilocybin-assisted Psychotherapy This will be the first clinical trial to investigate the use of psilocybin-assisted-psychotherapy in the treatment of Generalised Anxiety Disorder. The intervention is a combined pharmacological and psychological treatment. Dosing sessions The experimental drug is psilocybin, taken orally. There will be two dosing sessions approximately 3 weeks apart. Dose 1 = 25mg psilocybin; Dose 2 = 25 or 30mg psilocybin. Doses will be maintained at 25mg across both sessions unless the participant exhibits limited acute subjective response during the first session (as determined by acute effects questionnaires) without substantial adverse effects, in which case the dose will be increased to 30mg for the second session. A range of extra-pharmacological parameters are specified to optimise safety and efficacy. Psychotherapy The psychotherapy is conducted by qualified and experienced mental healthcare therapists who have also undergone an extensive trial-specific psychedelic therapist training program with supervised practice. All psychotherapy and dosing sessions will take part at BrainPark, Monash University, within comfortably furnished and aesthetically pleasing rooms. The psychological treatment comprises preparatory psychotherapy, dosing support, and integrative psychotherapy. *Preparatory psychotherapy includes a range of approaches supporting safe and effective dosing sessions, and sustained outcomes. 3-to-5 x 90-minute sessions will take place approximately weekly preceding the first dosing session. *Dosing session support occurs on the day of psilocybin administration, and is based on best-practice in psychedelic therapies, including a range of approaches that support safe and effective administration and sustained outcomes. 2 x 8-hour sessions will take place three weeks apart. *Integrative psychotherapy includes a range of approaches supporting sustained outcomes. Three integration psychotherapy sessions follow each dosing session, with one session the day after dosing and subsequent sessions approximately weekly thereafter. 6 x 90-minute sessions in total. Safety Participant heart rate, blood pressure, and general symptomology will be monitored throughout the dosing session. Rescue medications will also be on hand should certain adverse events not respond to other psychological support. Treatment Fidelity All dosing sessions will be video recorded and an independent expert will review excerpts for therapeutic supervision. Adherence to all sessions and any deviation from protocol will be documented.
Locations(1)
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ACTRN12621001358831