Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000971639
Ethics application status
Approved
Date submitted
15/08/2023
Date registered
6/09/2023
Date last updated
16/02/2024
Date data sharing statement initially provided
6/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
MDMA-assisted therapy for Post-Traumatic Stress Disorder in Military Veterans and First Responders
Scientific title
Safety and efficacy of MDMA-assisted therapy for Post-Traumatic Stress Disorder in Military Veterans and First Responders: a randomised waitlist-controlled clinical trial [MMP-1]
Secondary ID [1] 310394 0
None
Universal Trial Number (UTN)
U1111-1292-5966
Trial acronym
MMP-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Traumatic Stress Disorder 331144 0
Condition category
Condition code
Mental Health 327922 327922 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MDMA-assisted therapy: This study is a randomised controlled trial to test a 14-week program of MDMA-assisted therapy compared to a waitlist controlled condition. Treatment comprises 12 psychotherapy sessions and two dosing sessions using 3,4-methylenedioxymethamphetamine (MDMA). Participants will be supported throughout by two qualified mental health professionals (therapist dyad) for the duration of treatment.

The two dosing sessions will be spaced four weeks apart, using an initial dose of 120mg followed by a supplementary 40mg dose 1.5 hours later, unless contraindicated. Each session will last approx. 8 hours with two trial therapists providing support throughout.

Participants will also attend 12 psychotherapy sessions. These include three weekly preparatory sessions before the first dose, three integration sessions following the first dose, and six integration sessions following the second dose. Preparatory psychotherapy will include a range of approaches supporting safe and effective dosing sessions, and integrative psychotherapy will include a range of approaches supporting sustained outcomes. All psychotherapy sessions will run for 90 minutes and provide support relevant to PTSD symptoms and psychedelic experience.

Adherence to all sessions and any deviation from protocol will be documented.
Intervention code [1] 326797 0
Treatment: Drugs
Intervention code [2] 326847 0
Treatment: Other
Comparator / control treatment
The study is a randomised rater- and statistician-blinded waitlist-controlled trial. The waitlist condition is the comparator, during which participants will continue treatment as usual. "Treatment as usual" means the participant will continue any medications or psychological support they were using prior to the trial. The control group will be offered the active treatment after 23 week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 335774 0
Mean group difference in symptoms of PTSD as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score
Timepoint [1] 335774 0
Baseline (Week 1), Week 18
Secondary outcome [1] 425558 0
Mean group difference in quality of life, assessed with the Quality of Life Scale (EQ-5D-5L)
Timepoint [1] 425558 0
Baseline (Week 1), Week 18, Week 30 post-baseline
Secondary outcome [2] 425565 0
SAFETY OUTCOME: Mean group difference in incidence of Adverse Events of Special Interest (AESI), Treatment Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs) through the duration of the treatment, as measured using trial AE/SAE report forms that follow the CTCAE v5. Examples of known/ possible adverse events include headaches, heightened anxiety, or insomnia.
Timepoint [2] 425565 0
All study therapy and assessment visits
Secondary outcome [3] 425566 0
SAFETY OUTCOME: Mean group difference in suicidality, assessed using the Ultra Brief Checklist for Suicidality (UBSC)
Timepoint [3] 425566 0
Baseline (Week 1), Week 8, Week 9, Week 11, Week 12, Week 13, Week 15, Week 18, Week 21, Week 24, Week 27, Week 30 post-baseline
Secondary outcome [4] 425878 0
Changes in functional impairment, assessed using the Sheehan Disability Scale (SDS)
Timepoint [4] 425878 0
Baseline (Week 1), Week 18, Week 30 post-baseline
Secondary outcome [5] 425879 0
Change in quality of life, assessed with the Quality of Life Scale (EQ-5D-5L)
Timepoint [5] 425879 0
Baseline (Week 1), Week 18 post-baseline
Secondary outcome [6] 425881 0
EXPLORATORY ENDPOINT: Depressive symptom severity, assessed with Patient Health Questionnaire (PHQ-9)
Timepoint [6] 425881 0
Baseline (Week 1), Week 18, Week 30 post-baseline
Secondary outcome [7] 425882 0
EXPLORATORY MEASURE: Changes in anxiety, assessed using the Generalised Anxiety Disorder 7-item Scale (GAD7)
Timepoint [7] 425882 0
Baseline (Week 1), Week 11, Week 15, Week 18, Week 30 post-baseline
Secondary outcome [8] 431814 0
Mean change from Baseline in long term symptoms of PTSD as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score for both groups.
Timepoint [8] 431814 0
Secondary outcome [9] 431815 0
Mean change from Baseline in long term symptoms of PTSD as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score for both groups.
Timepoint [9] 431815 0
Baseline, Week 30 post-baseline

Eligibility
Key inclusion criteria
*Adults with current diagnosis of PTSD.
*Military veteran or first responder
*Proficiency in English.
*Availability of appropriate Support Person (relative, spouse, close friend) who can transport and provide basic support to participants following the dosing sessions.
*Ability to discontinue certain excluded medications if deemed safe, appropriate, agreeable; if discontinuation can occur under guidance of prescribing doctor. (Note, prospective participants are not required to discontinue any medications prior to written confirmation of their enrolment into the study).
*Agree to all study-related requirements.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any CNS disorders
• Current or past history of meeting DSM-5 criteria for certain excluded psychiatric indications.
• Have history of any medical condition that could make receiving a sympathomimetic drug harmful, or have any relevant cardiovascular conditions
• Diagnosis of epilepsy or previous seizures
• Major liver, kidney, thyroid abnormalities
• Insulin-dependent diabetes (unless well-managed)
• Pregnant, nursing, trying to conceive
• Taking, and inappropriate to discontinue, excluded medications, including SSRIs, SNRIs, potent metabolic inducers or inhibitors.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be randomised after enrolment to either an early access condition or waitlist condition. An unblinded Randomisation Monitor (who is external to trial staff) will generate a randomisation list and allocate participants once enrolled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/09/2023
Actual
10/11/2023
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314594 0
University
Name [1] 314594 0
Monash University
Country [1] 314594 0
Australia
Funding source category [2] 314596 0
Other
Name [2] 314596 0
Philanthropic - private
Country [2] 314596 0
Australia
Funding source category [3] 314760 0
Charities/Societies/Foundations
Name [3] 314760 0
Multidisciplinary Association for Psychedelic Studies
Country [3] 314760 0
United States of America
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd,Clayton, Victoria 3800
Country
Australia
Secondary sponsor category [1] 316560 0
None
Name [1] 316560 0
None
Address [1] 316560 0
None
Country [1] 316560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313628 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 313628 0
Room 111, Chancellery Building D, 26Sports Walk, Clayton Campus, Research Office,Monash University VIC 3800
Ethics committee country [1] 313628 0
Australia
Date submitted for ethics approval [1] 313628 0
21/02/2023
Approval date [1] 313628 0
06/04/2023
Ethics approval number [1] 313628 0

Summary
Brief summary
This clinical trial will investigate the safety and efficacy of a 14-week MDMA assisted psychotherapy treatment for PTSD. The primary outcome measure will assess clinician-rated changes in PTSD severity, alongside a range of secondary and exploratory measures assessing functional impairment associated with PTSD, quality of life, relationships to adverse childhood experiences, and changes in comorbid psychiatric symptoms. Safety outcome measures will also investigate the safety and tolerability of the drug.
Trial website
https://www.monash.edu/medicine/scs/clinical-psychedelic-lab/research
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128798 0
Dr Paul Liknaitzky
Address 128798 0
Monash University770 Blackburn Rd,Clayton, Victoria, 3168
Country 128798 0
Australia
Phone 128798 0
+61 3 9905 2038
Fax 128798 0
Email 128798 0
Paul.L@monash.edu
Contact person for public queries
Name 128799 0
Dr Paul Liknaitzky
Address 128799 0
Monash University770 Blackburn Rd,Clayton, Victoria, 3168
Country 128799 0
Australia
Phone 128799 0
+61 3 9905 2038
Fax 128799 0
Email 128799 0
psychedelic@monash.edu
Contact person for scientific queries
Name 128800 0
Dr Paul Liknaitzky
Address 128800 0
Monash University770 Blackburn Rd,Clayton, Victoria, 3168
Country 128800 0
Australia
Phone 128800 0
+61 3 9905 2038
Fax 128800 0
Email 128800 0
psychedelic@monash.edu

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


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.