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Trial registered on ANZCTR


Registration number
ACTRN12622000463774
Ethics application status
Approved
Date submitted
8/03/2022
Date registered
24/03/2022
Date last updated
25/04/2024
Date data sharing statement initially provided
24/03/2022
Date results information initially provided
25/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Psilocybin-facilitated treatment for methamphetamine Use Disorder: A pilot study (Psi-MA)
Scientific title
Safety, tolerability, and feasibility of psilocybin-facilitated treatment for methamphetamine use disorder: A pilot study (Psi-MA): A pilot study (Psi-MA)
Secondary ID [1] 306617 0
CT-2020-CTN-03952-1
Universal Trial Number (UTN)
U1111-1253-8258
Trial acronym
Psi-MA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Use Disorder 325539 0
Condition category
Condition code
Mental Health 322910 322910 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Three 90 minute preparatory psychotherapy sessions over two weeks facilitated by dyad of trained clinical psychologists and psychiatrist; includes alliance building, intention setting, psychoeducation and non-avoidance training.
2. Psilocybin one 25mg oral capsule within 1-2 days of the last preparatory psychotherapy session; dosing session facilitated by same therapist dyad over 8 hours following the single supervised dose.
3. Two 60 minute post-psilocybin integration psychotherapy sessions facilitated by same therapist dyad; first session within 1 week of psilocybin dosing and second the following week.
Intervention occurs over 4 weeks. Adherence to intervention ensured by session checklists and filming of dosing day.
Intervention code [1] 323062 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330681 0
Safety assessed as adverse events (e.g. sweating, nausea, vomiting) on participant self-report, documented in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0)'
Timepoint [1] 330681 0
Assessed from recruitment at the following time points:
Each of the 3 preparatory psychotherapy sessions
Psilocybin dosing day
Days 1, 7, and 28 days post psilocybin dose
Primary outcome [2] 330734 0
Feasibility: Measured by ratios of screened to recruited and drop out rate
Timepoint [2] 330734 0
Assessed daily from the point of screening to 28 days post psilocybin dose
Secondary outcome [1] 407202 0
Methamphetamine use assessed by timeline followback and drug urinalysis
Timepoint [1] 407202 0
Assessed by timeline followback (28 or 7) to cover the entire study period and 28 days prior to recruitment at the following time points:
Baseline screening
Each of the 3 preparatory psychotherapy sessions
Psilocybin dosing day
Days 1, 7, and 28 days post psilocybin dose

Drug urinalysis:
Screening baseline
Preparatory psychotherapy session #2
Psilocybin dosing day
Day 7 and day 28 post psilocybin dosing day
Secondary outcome [2] 407368 0
Methamphetamine cravings measured using visual analogue scale
Timepoint [2] 407368 0
Assessed at the following time points:
Baseline screening
Each of the 3 preparatory psychotherapy sessions
Psilocybin dosing day
Days 1, 7, and 28 days post psilocybin dose
Secondary outcome [3] 407369 0
Other illicit drug use assessed by timeline follow back and drug urinalysis
Timepoint [3] 407369 0
Assessed by timeline followback (28 or 7) to cover the entire study period and 28 days prior to recruitment at the following time points:
Baseline screening
Each of the 3 preparatory psychotherapy sessions
Psilocybin dosing day
Days 1, 7, and 28 days post psilocybin dose
Secondary outcome [4] 407370 0
Co-morbid mental illness (anxiety, depression, insomnia) assesed with psyhiatric assessment, brief psychiatric rating scale (BPRS), DASS-21, insomnia severity index)
Timepoint [4] 407370 0
Psychiatric assessment: Baseline screening

BPRS/DASS-21/insomnia severity index: Baseline screening, psychotherapy session #1, dosing day, day 1, 7, 28 post psilocybin dose
Secondary outcome [5] 407371 0
Quality of life measured with EUROQOL-5D and SF-36
Timepoint [5] 407371 0
Baseline screening, day 28 post psilocybin dose
Secondary outcome [6] 407372 0
Staffing and other capital resource costs associated with delivering intervention measured according to staff time, therapy room set up and running, pharmaceutical intervention including cost of investigational product and pharmacy costs.
Timepoint [6] 407372 0
Measured accross entire study
Secondary outcome [7] 407373 0
Changes in resting state brain network activity using resting state functional MRI (rs-fMRI)
Timepoint [7] 407373 0
within 1 week of intiation of preparatory psychoterhapy and repeated within the week following psilocybin dosing
Secondary outcome [8] 407374 0
Changes in plasma biomarkers associated with neuroinflammation and neuroplasticity.
Timepoint [8] 407374 0
Blood taken at baseline screening, day 1, 7 and 28 post psilocybin dose
Secondary outcome [9] 407375 0
Patient experience of psilocybin psychotherapy measured by qualitative interview
Timepoint [9] 407375 0
within 1 week of intiation of preparatory psychoterhapy and repeated day 28 following psilocybin dosing

Eligibility
Key inclusion criteria
· Aged 25 years and above
· Meet DSM-5 criteria for methamphetamine use disorder (MAUD) as determined by an Addiction Specialist
· Used MA on less than 16 out of the prior 28 days
· Currently seeking treatment for methamphetamine use disorder
· Have at least one urine drug screen positive for methamphetamine within 1 month of trial registration
· Ability to read/write in English
· Availability of a friend or family member into whose care the participant can be released following their drug administration session for the subsequent 24 hours
· Home-like environment in which to be cared for the 24 hours following psilocybin dosing
· In good general health as assessed by detailed medical history and physical examination
· Abstinence from methamphetamine, other illicit drugs (including extra-medical use of opioids and benzodiazepines), and alcohol for at least 2 days prior to psilocybin administration as confirmed via urinalysis and no signs of intoxication or withdrawal on the day of psilocybin administration
· Good engagement with psychotherapy team at pre-psilocybin psychotherapy session immediately prior to psilocybin dosing session, and consensus on good alliance from both therapists.
· Can swallow pills
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
· Women who are pregnant or breast feeding or of childbearing potential and not willing to avoid becoming pregnant during the study
· Medically significant condition which, in the opinion of the investigator would render a patient unsuitable for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc).
· Current hypertension uncontrolled by a single antihypertensive (exceeding 140 mmHg systolic and 90 mmHg diastolic after 15 minutes of rest, averaged across four assessments on at least two separate days.)
· History of psychiatric illness other than substance use disorder that is severe within the last 5 years as assessed by a psychiatrist, or any other condition that may compromise patient safety as assessed by psychiatrist
· Current use of antidepressant medication, specifically monoamine oxidase inhibitors, antipsychotic medications, St. John's Wort, or other medications as determined by the study psychiatrist
· Any of the following on clinical interview with a psychiatrist:
o History of any drug induced psychosis or any psychotic disorder or psychotic episode
o History of bipolar I or II disorder
o History of anorexia nervosa or bulimia nervosa
o First or second-degree relatives with history of any psychotic disorders, or bipolar I or II disorders
o Current suicidal or homicidal ideation
· History of any other illicit drug, illicit or prescribed benzodiazepine use extra-medical use of opioids within the 2 days preceding psilocybin administration. People receiving opioid substitution therapy who otherwise meet the eligibility criteria may be included.
· History of alcohol use disorder within the preceding 3 months
· History of cannabis use disorder within the preceding 3 months
· Use of a classical hallucinogen (LSD, DMT, psilocybin, mescaline, salvia divinorum, ibogaine) within the preceding 28 days.
· Planning to move from the Sydney area in the next 6 months or any other reason precluding follow up in this time period (e.g. likely travel or imprisonment)
· Contraindications of MRI (metallic objects in the body, claustrophobia, difficulty with prior MRI)
· Unstable housing or homeless
· Inability to attend all screening visits

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/12/2022
Actual
13/12/2022
Date of last participant enrolment
Anticipated
20/11/2024
Actual
1/11/2023
Date of last data collection
Anticipated
23/02/2024
Actual
1/03/2024
Sample size
Target
15
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310950 0
Other Collaborative groups
Name [1] 310950 0
The National Centre for Clinical Research on Emerging Drugs (NCCRED)
Country [1] 310950 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital, Sydney
Address
390 Victoria Street,
Darlinghurst,
Sydney, NSW, Australia, 2010
Country
Australia
Secondary sponsor category [1] 312259 0
None
Name [1] 312259 0
Address [1] 312259 0
Country [1] 312259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310509 0
St. Vincent's Hospital, Sydney Human Research Ethics Committee
Ethics committee address [1] 310509 0
St. Vincent's Hospital
390 Victoria Street,
Darlinghurst, Sydney, NSW, 2010
Ethics committee country [1] 310509 0
Australia
Date submitted for ethics approval [1] 310509 0
Approval date [1] 310509 0
09/08/2020
Ethics approval number [1] 310509 0
ETH01695

Summary
Brief summary
This is a single centre, single arm, study primarily examining the safety and feasibility of psychotherapy combined with a single dose of 25mg psilocybin.
Study Hypothesis: That psilocybin psychotherapy for methamphetamine dependence can be safely and feasibly delivered from a public addiction outpatient clinic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117902 0
A/Prof Jonathan Brett
Address 117902 0
Clinical Therapeutics
Level 2 Xavier Building
St. Vincent's Hospital
390 Victoria Street, Darlinghurst
Sydney, NSW
2010
Country 117902 0
Australia
Phone 117902 0
+61 487468199
Fax 117902 0
Email 117902 0
jonathan.brett@svha.org.au
Contact person for public queries
Name 117903 0
A/Prof Jonathan Brett
Address 117903 0
Clinical Therapeutics
Level 2 Xavier Building
St. Vincent's Hospital
390 Victoria Street, Darlinghurst
Sydney, NSw
2010
Country 117903 0
Australia
Phone 117903 0
+61 02 8382 1111
Fax 117903 0
Email 117903 0
jonathan.brett@svha.org.au
Contact person for scientific queries
Name 117904 0
A/Prof Jonathan Brett
Address 117904 0
Clinical Therapeutics
Level 2 Xavier Building
St. Vincent's Hospital
390 Victoria Street, Darlinghurst,
Sydney, NSW
2010
Country 117904 0
Australia
Phone 117904 0
+61 02 8382 1111
Fax 117904 0
Email 117904 0
jonathan.brett@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient privacy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.