Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622001525774
Ethics application status
Approved
Date submitted
5/09/2022
Date registered
9/12/2022
Date last updated
29/05/2024
Date data sharing statement initially provided
9/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing Optimal Psychedelic Assisted Psychotherapy for Obsessive-Compulsive Disorder
Scientific title
Developing Optimal Psychedelic Assisted Psychotherapy: Investigating the Effect on Symptom Severity for Adults with Obsessive-Compulsive Disorder
Secondary ID [1] 307891 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OPT-PAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Obsessive-Compulsive Disorder 327528 0
Condition category
Condition code
Mental Health 324629 324629 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MDMA + Exposure Response Prevention Intervention:
Session plan – minimum of 2 preparation sessions, 3 MDMA sessions (2-6 weeks apart), 4 integration sessions, for example:

Week 1 Preparation session 1
Week 2 Preparation session 2
Week 3 MDMA 1 + integration session 1
Week 4 Preparation session 3 (optional)
Week 5 MDMA 2 + Integration session 2
Week 6 Preparation session 4 (optional)
Week 7 MDMA 3 + Integration session 3
Week 8 Integration session 4

The therapists conducting these sessions are health/healing professionals (doctor, psychiatrist, psychologist, psychotherapist, counsellor, nurse) trained in the administration of psychedelic assisted psychotherapy.

Adherence will be recorded electronically through a session attendance checklists as part of their study file.

Overview of 2 x preparation sessions for MDMA:
There will be a minimum of two 90-minute preparation sessions conducted remotely or in person with a therapist. There also will be an opportunity for participants to engage in an optional preparation session prior to the second and third medication session. The participant will have the opportunity to meet the therapists/staff who will be present in the MDMA dosing session prior to dosing, during this preparation phase (more preparation sessions will be provided if deemed necessary by the therapist).

Preparation session 1:
Alliance development and formulation: the primary aims of the initial session will be the development of a therapeutic alliance, build trust and safety between the study therapists and the participant.
Clarify participant intentions for the MDMA session, anxieties and hopes for the experience.
Discuss ethical considerations and participant choices around use of touch, grounding techniques, and preferences such as music playlist, utilising eye mask, what will happen in the MDMA session, expectations and concerns and previous experience, media awareness or knowledge of psychedelic therapy.
Inform them about what to expect during the MDMA sessions, psychological and physiological effects, who will be present, and the integration process. Preparing social support and integration for after the dosing session. Support person should be informed of the nature of the study.
Gain an understanding of participant’s obsessional thoughts and associated avoidance, rituals or compulsive behaviours, and the situations which act as triggers for them. Eliciting and defining the range of OCD thoughts and behaviours via a thorough symptom review, using the Yale-Brown Obsessive Compulsive Scale (YBOCS).

Between session task: Participant completes an OCD self-monitoring worksheet (this will take no more than 5 minutes per day to complete).

Preparation Session 2:
Therapist/s continue to build trust and rapport with participant. Participant meets one or two of the therapists who will be present during the dosing session.
Review self-monitoring sheet and further clarify intentions, including exposure hierarchy, for the MDMA session.
Psychoeducation around exposure therapy, OCD, and the role of avoidance in maintaining OCD.
Goals are developed collaboratively between the therapists and the participant, based around anxiety provoking situations of increasing difficulty during MDMA sessions. With the therapist’s help the client identifies situations that trigger obsessions or compulsions (exposure), while refraining from the compulsive behaviours they usually perform (response prevention), during the MDMA session. Developing an anxiety hierarchy and an exposure response plan - this involves developing, for each exposure task, response prevention goals, where the client purposefully refrains from engaging in the usual OCD rituals or compulsions during the MDMA session.
Discuss common experiences in MDMA session including transpersonal, spiritual aspects and approaching difficult and intense experiences. Information on non-ordinary states of consciousness, preparing to be open and curious in observing what arises.
Practical guidance and safety instructions, including departure requirements.

Optional Preparation Session 3:
Occurs after the first MDMA session, and before the second MDMA session.
Review intentions for the second MDMA session flexibly, as these may have changed since the first MDMA session. Building upon the first integration session, reflect on insights gained.
Where applicable, collaboratively review exposure hierarchy, re-rate SUDS and set ERP plan for the second MDMA session.

Overview of dosing sessions:
The medication sessions will be conducted at Monarch Mental Health Group (MMHG) clinical facilities in Sydney and Melbourne.
There will be three dosing sessions conducted between 2 and 6 weeks apart. A single dose of 100mg MDMA in an oral capsule will be administered by a medical practitioner or nurse to the participant.
Each session will last up to 8 hours and will be conducted with each individual participant separately. Prior to the participant’s arrival, the room will be prepared such that it provides a safe, warm, private atmosphere with the provision for music, eye shades, gentle lighting, and the ability for the participant to lie down with an appropriate blanket and pillow.

Overview of 4 x MDMA integration sessions:
The participant will be engaged in a 90-minute debriefing / integration session within 72 hours after each medication session. These may be conducted in person or remotely. The purpose of the debriefing / integration sessions is to support the participant in their ability to reflect on the medication sessions and to help them to make meaning and clarify insights that may have been developed. The primary activity of the therapists in these sessions is to ask open-ended questions to elicit insights that the participant may have come to and how the insights can be generalised into their life and a variety of setting. Sessions may incorporate values work and setting ongoing ERP tasks between the MDMA dosing sessions. There may be some discussion of how the insights and changes in participant’s values may be reflected in alterations they may make in specific day-to-day behaviours, and clarification of intentions for the next dosing session. In addition, patients may be provided support to continue with ERP related therapeutic activities.

Integration session 1:
Occurs within a week after the first dosing.
Participant and therapist reflect on insights gained in the first dosing; any new adaptive information gained. Encourage ongoing ERP tasks between sessions and consolidate adaptive meaning making. Create space to discuss new concerns which may emerge in the medicine session, normalise experience and begin to establish intentions for the next MDMA session.

Integration session 2:
Occurs within a week after the second dosing.
As above, participant and therapist reflect on insights gained in the second dosing; any new adaptive information gained. Encourage ongoing ERP tasks between sessions and consolidate adaptive meaning making. Create space to discuss new concerns which may emerge in the medicine session, normalise experience and begin to establish intentions for the third and final MDMA session.

Integration session 3:
Occurs within a week after the third dosing.
As above, participant and therapist reflect on insights gained in the first dosing; any new adaptive information gained. Encourage ongoing ERP tasks between sessions and consolidate adaptive meaning making. Preparation for the end of the trial and plan for ongoing support and aftercare.

Integration session 4:
Occurs 2 weeks after the last dosing session.
Final session with study therapists and participant together, focused on consolidating insights and gains, review progress with ERP hierarchy and relapse prevention strategies. Values work. Importantly, the therapists acknowledge participant’s hard work, and provide warm handovers for any outstanding concerns. Identify any new goals in recovery. Explore barriers to accessing ongoing support and address same. Potential to bring in a family member or loved one for support with their plan for ongoing recovery.

EEG Component:
A subset of participants will also undergo an electroencephalogram (EEG) recording session on three occasions: at baseline, and following the first and third drug session. These recordings will be conducted by trained research staff. Please note, the subset of participants receiving EEG recordings will be determined by equipment availability.
Intervention code [1] 324350 0
Treatment: Drugs
Intervention code [2] 324351 0
Treatment: Other
Comparator / control treatment
Psilocybin + ACT Intervention:
The psilocybin + ACT intervention is adapted with permission from the Yale Psilocybin for Depression Manual.
Session plan – minimum of 2 preparation sessions, 3 Psilocybin sessions (2-6 weeks apart), 4 integration sessions, for example:

Week 1 Preparation session 1
Week 2 Preparation session 2
Week 3 Psilocybin 1 + integration session 1
Week 4 Preparation session 3 (optional)
Week 5 Psilocybin 2 + Integration session 2
Week 6 Preparation session 4 (optional)
Week 7 Psilocybin 3 + Integration session 3
Week 8 Integration session 4

The therapists conducting these sessions are health/healing professionals (doctor, psychiatrist, psychologist, psychotherapist, counsellor, nurse) trained in the administration of psychedelic assisted psychotherapy.
Adherence will be recorded electronically through a session attendance checklists as part of their study file.

Overview of 2 x preparation sessions for psilocybin:
There will be a minimum of two 90-minute preparation sessions conducted remotely or in person with a therapist. There also will be an opportunity for participants to engage in an optional preparation session prior to the second and third medication session. The participant will have the opportunity to meet the therapists/staff who will be present in the psilocybin dosing session prior to dosing, during this preparation phase (more preparation sessions will be provided if deemed necessary by the therapist).

Preparation session 1:
Alliance development and formulation: the primary aims of the initial session will be the development of a therapeutic alliance, build trust and safety between the study therapists and the participant.
Listening to participant’s narrative of depression and treatment history to understand patterns of psychological inflexibility that are most prominent.
Clarify participant intentions for the psilocybin session, anxieties and hopes for the experience.
Discuss ethical considerations and participant choices around use of touch, grounding techniques, and preferences such as music playlist, utilising eye mask, what will happen in the psilocybin session, expectations and concerns and previous experience, media awareness or knowledge of psychedelic therapy.
Psychoeducation around psychological and physiological effects of psilocybin, who will be present, and the integration process. Preparing social support and integration for after the dosing session. Support person should be informed of the nature of the study.
Introduce ACT, concept of psychological flexibility and observing experience with curiosity and openness, rather than avoidance.
Grounding exercises and scripts for difficult experience, information on non-ordinary states of consciousness, based on the study manual.

Preparation Session 2:
Therapist/s continue to build trust and rapport with participant. Participant meets one or two of the therapists who will be present during the dosing session.
Review valued living questionnaire and further clarify intentions, for the psilocybin session.
Introduce ACT hexaflex model. Prime the participant to register elements of the psilocybin sessions as reflecting ACT-defined shifts in thinking, behaviour, and awareness of values.
Collaboratively set intentions for the medicine session.
Discuss common experiences in psilocybin session including transpersonal, spiritual aspects and approaching difficult and intense experiences with openness and curiosity
Grounding exercises i.e., breathing techniques
Practical guidance and safety instructions, including departure requirements.

Optional Preparation Session 3:
Occurs after the first psilocybin session, and before the second psilocybin session.
Conduct psychoeducation regarding the cognitive processes and behaviours that contribute to OCD from an ACT perspective (i.e., cognitive fusion, experiential avoidance, etc). How patterns can be changed through an interactive process between the principles of ACT and the experience with psilocybin, and mindfulness practice.
Review intentions for the second psilocybin session flexibly, as these may have changed since the first session. Building upon the first integration session, reflect on insights gained.

Overview of dosing sessions:
The medication sessions will be conducted at Monarch Mental Health Group (MMHG) clinical facilities in Sydney and Melbourne.
There will be three dosing sessions conducted between 2 and 6 weeks apart. A single dose of 25mg psilocybin in an oral capsule will be administered by a medical practitioner or nurse to the participant.

Each session will last up to 8 hours and will be conducted with each individual participant separately. Prior to the participant’s arrival, the room will be prepared such that it provides a safe, warm, private atmosphere with the provision for music, eye shades, gentle lighting, and the ability for the participant to lie down with an appropriate blanket and pillow.

Overview of 4 x psilocybin integration sessions:
The participant will be engaged in a 90-minute debriefing / integration session within 72 hours after each medication session. These may be conducted in person or remotely. The purpose of the debriefing / integration sessions is to support the participant in their ability to reflect on the medication sessions and to help them to reach insights that may have been developed. The primary activity of the therapists in these sessions is to ask open-ended questions to elicit insights that the participant may have come to. The therapist may identify elements of the participant’s narrative consistent with ACT principles and help them to understand their experience in this context. The integration sessions may also involve an exploration of values and how these may have evolved through the process of the treatment sessions. There may be some discussion of how the insights and changes in participant’s values may be reflected in alterations they may make in specific day-to-day behaviours. An ACT framework will be used to guide this process.

Integration session 1:
Occurs within a week after the first dosing.
Participant and therapist reflect on insights gained in the first dosing; any challenges or new adaptive information gained. Therapist elicits complete narrative of participant’s experience during medication session. Identify and explore aspects of the participant’s narrative that engage with ACT principles, as well as instances when they moved toward or away from psychological flexibility. Create space to discuss new concerns which may emerge in the medicine session, normalise experience and begin to establish intentions for the next psilocybin session.

Integration session 2:
Occurs within a week after the second dosing.
As above, participant and therapist reflect on insights gained in the second dosing; any challenges or new adaptive meaning-making. Therapist and participant continue to review and reflect on the participant’s psilocybin experience, including any emotional, mental, or lifestyle changes that followed the dosing session. Reflect on values, by discussing the participant’s completed Valued Living Questionnaire, and relative importance of valued domains of living. Reflect on experiences living in accordance with or not living in alignment with their values. Create space to discuss new concerns which may emerge in the medicine session, normalise experience and begin to establish intentions for the third and final psilocybin session.

Integration session 3:
Occurs within a week after the third dosing.
As above, participant and therapist reflect on insights gained in the third dosing; any challenges or new adaptive information gained. Therapist elicits complete narrative of participant’s experience during medication session, exploring aspects of the experience in relation to ACT principles discussed previously. Therapist may use Metaphors derived from psilocybin experience or from ACT to aid in understanding of the principles, such as self-as-context. Preparation for the end of the trial and plan for ongoing support and aftercare.

Integration session 4:
Occurs 2 weeks after the last dosing session.
Final session with study therapists and participant together, focused on consolidating insights and gains during the study. Therapist continues to explore and reinforce adaptive meanings gained from the psilocybin experience, while assessing for changes in psychological flexibility. Discussion around where the dosing and therapy sessions brought each ACT process to light, using the ACT hexaflex. Discussion of relevant ACT concepts, values-based action and successful behavioural changes and committed actions taken. Relapse prevention utilising meditation and mindfulness practices and other concrete ways the study experience can be translated into lasting changes. Importantly, the therapists acknowledge participant’s hard work, and provide warm handovers for any outstanding concerns. Identify any new goals in recovery. Explore barriers to accessing ongoing support and address same. Potential to bring in a family member or loved one for support with their plan for ongoing recovery.

EEG Component:
A subset of participants will also undergo an electroencephalogram (EEG) recording session on three occasions: at baseline, and following the first and third drug session. These recordings will be conducted by trained research staff. Please note, the subset of participants receiving EEG recordings will be determined by equipment availability.
Control group
Active

Outcomes
Primary outcome [1] 332447 0
Total score on the Yale-Brown Obsessive-Compulsive Scale (YBOCS).
Timepoint [1] 332447 0
Baseline compared to study timepoints: Post Drug therapy session 1, Post Drug therapy session 2, Post Drug therapy session 3, End Integration Therapy (8 weeks post-baseline) (primary timepoint), and 1, 3 and 6 months post-integration therapy completion
Secondary outcome [1] 413536 0
Total score on the Self-rated version of the Montgomery Asberg depression rating scale
Timepoint [1] 413536 0
Baseline compared to study timepoints: Post Drug therapy session 1, Post Drug therapy session 2, Post Drug therapy session 3, End Integration Therapy (8 weeks post-baseline), and 1, 3 and 6 months post-integration therapy completion
Secondary outcome [2] 413537 0
Patients Global Impression of Improvement Scale (PGI-I)
Timepoint [2] 413537 0
End Integration Therapy (8 weeks post-baseline) compared to study timepoints: 1, 3 and 6 months post-integration therapy completion
Secondary outcome [3] 413538 0
Depression, Anxiety and Stress Scale (DASS10)
Timepoint [3] 413538 0
Baseline compared to study timepoints: End Integration Therapy (8 weeks post-baseline), and 6 months post-integration therapy completion
Secondary outcome [4] 413539 0
Generalised Anxiety Disorder (GAD-7)
Timepoint [4] 413539 0
Baseline compared to study timepoints: End Integration Therapy (8 weeks post-baseline), and 6 months post-integration therapy completion
Secondary outcome [5] 413540 0
Assessment of Quality of Life (AQoL-6D)
Timepoint [5] 413540 0
Baseline compared to study timepoints: End Integration Therapy (8 weeks post-baseline), and 6 months post-integration therapy completion
Secondary outcome [6] 413541 0
12 Item World Health Organisation Disability Assessment Schedule (WHODAS 2.0)
Timepoint [6] 413541 0
Baseline compared to study timepoints: End Integration Therapy (8 weeks post-baseline), and 6 months post-integration therapy completion
Secondary outcome [7] 413542 0
The Acceptance and Action Questionnaire (AAQ-2)
Timepoint [7] 413542 0
Baseline compared to study timepoints: End Integration Therapy (8 weeks post-baseline), and 6 months post-integration therapy completion
Secondary outcome [8] 413543 0
The Watts Connectedness Scale
Timepoint [8] 413543 0
Baseline compared to study timepoints: End Integration Therapy (8 weeks post-baseline), and 6 months post-integration therapy completion
Secondary outcome [9] 413544 0
The Mystical Experience Questionnaire (MEQ)
Timepoint [9] 413544 0
End of Integration Therapy (8 weeks post-baseline) compared to study timepoint: 6 months post-integration therapy completion
Secondary outcome [10] 413545 0
Side effects questionnaire designed specifically for this study to measure any side effects from the treatment session.
Timepoint [10] 413545 0
Conducted 3 Days Post Drug therapy session 1, 3 Days Post Drug therapy session 2, 3 Days Post Drug therapy session 3, and End of Integration Therapy (8 weeks post-baseline)
Secondary outcome [11] 413547 0
Ten minutes of eyes closed resting EEG data to assess excitation/inhibition balances
Timepoint [11] 413547 0
Baseline EEG (pre psilocybin or MDMA session) compared to study timepoints: Post Drug therapy session 1 and Post Drug therapy session 3.
Secondary outcome [12] 413548 0
A Latent Inhibition task to assess the personality trait of openness
Timepoint [12] 413548 0
Baseline EEG (pre psilocybin or MDMA session) compared to study timepoints: Post Drug therapy session 1 and Post Drug therapy session 3.
Secondary outcome [13] 413549 0
Arrow version of Eriksen Flanker Task to assess reaction time, where longer reaction times correspond to greater attentional processing time, and accuracy rate where greater accuracy is assumed to be related to a better allocation of attentional resources
Timepoint [13] 413549 0
Baseline EEG (pre psilocybin or MDMA session) compared to study timepoints: Post Drug therapy session 1 and Post Drug therapy session 3.
Secondary outcome [14] 413550 0
A Go/NoGo task to assess response inhibition
Timepoint [14] 413550 0
Baseline EEG (pre psilocybin or MDMA session) compared to study timepoints: Post Drug therapy session 1 and Post Drug therapy session 3.
Secondary outcome [15] 413553 0
The patient global impression of severity (PGI-S)
Timepoint [15] 413553 0
Baseline compared to study timepoints: End Integration Therapy (8 weeks post-baseline), and 1, 3 and 6 months post-integration therapy completion
Secondary outcome [16] 416660 0
Treatment acceptability and tolerability questionnaire designed specifically for this study to measure treatment acceptability and tolerability
Timepoint [16] 416660 0
Conducted 3 Days Post Drug therapy session 1, 3 Days Post Drug therapy session 2, 3 Days Post Drug therapy session 3, and End of Integration Therapy (8 weeks post-baseline)
Secondary outcome [17] 416665 0
Blinding Questionnaire designed specifically for this study to measure blinding
Timepoint [17] 416665 0
Conducted 3 Days Post Drug therapy session 1, 3 Days Post Drug therapy session 2, 3 Days Post Drug therapy session 3, and End of Integration Therapy (8 weeks post-baseline)

Eligibility
Key inclusion criteria
Diagnosis of Obsessive-Compulsive Disorder, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5)

25-65 years of age.

Treatment resistant symptoms:
For OCD: failure to tolerate or respond to at least 2 trials of adequate medication therapy (SSRI or clomipramine) at minimum effective therapeutic dose for at least 8 weeks
Moderate – severe symptoms:
For OCD: YBOCS score of >13

Demonstrated capacity to give informed consent

Willingness and capacity (as judged on assessment by study clinicians) to engage in the therapeutic elements of the study protocol
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are not able to give adequate informed consent.

Current or previously diagnosed psychotic disorder, schizophrenia or bipolar disorder

Immediate family member with a diagnosed psychotic disorder

Significant history of mania.

Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure)

History of serious suicide attempts in recent years requiring hospitalisation as judged by a study psychiatrist at initial assessment to impact on safety of participation.

Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin / MDMA, e.g., borderline personality disorder

Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.

Participants who do not agree to use an acceptable contraceptive method throughout their participation in the study.

Current drug or alcohol dependence

Recreational use in last 12 months of psychedelic substances or a history of regular psychedelic use

No email access/ability or no willingness to engage in follow up by electronic questionnaires

Use of contraindicated medication (outlined further below) including MAOI, SSRI or SNRI: SSRI/SNRI withdrawal for at least one week (4 weeks for fluoxetine), 2 weeks for irreversible MAOI

Use within 5 half-lives of any other serotonin-enhancing medication

Participants presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)

Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.

Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.

BMI <17 or >42

Participants with significant difficulties in English comprehension or communication.

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)
Allocation to treatment group is concealed; by the research staff contacting the study investigators, who have a computer generated random sequence for treatment groups, after the participant is deemed eligible and has consented for the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to study group using simple randomisation techniques i.e. using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We aim to include a total of 40 participants, 20 per group. The primary analysis will be descriptive in regard to the rates of remission and response. This study will have sufficient power (>0.85) to show a clinically significant reduction (6 points) in YBOCS scores for each group given a standard deviation of 6 (alpha of 0.05).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
18/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312166 0
Other Collaborative groups
Name [1] 312166 0
Monarch Mental Health Group
Country [1] 312166 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
The Australian National University
Canberra ACT 2600 Australia
Country
Australia
Secondary sponsor category [1] 313694 0
None
Name [1] 313694 0
Address [1] 313694 0
Country [1] 313694 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311555 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 311555 0
2-6 Bowes Street, Phillip, ACT 2606
Woden Valley
Ethics committee country [1] 311555 0
Australia
Date submitted for ethics approval [1] 311555 0
09/11/2022
Approval date [1] 311555 0
06/02/2023
Ethics approval number [1] 311555 0

Summary
Brief summary
There is increasing evidence that new interventional pharmacotherapies such as psychedelic therapy may be helpful for the treatment of a number of mental health conditions. The purpose of this study is to explore the potential for psychedelic therapy using psilocybin and MDMA to improve symptoms of treatment resistant OCD, and to determine whether there is any pre-post change in electroencephalography (EEG) measurements following psychedelic exposure. To do so, we will carry out a double blind (participant and rater) clinical trial of psilocybin and MDMA assisted psychotherapy in 40 participants (20:20 drug allocation) with treatment resistant OCD. Participants will undergo a series of preparation and integration therapy sessions and 3 drug administration sessions. The results of this study will provide us information about the effectiveness, acceptability, and tolerability of this treatment for this disorder, as well as whether there are any brain activity changes associated with having been exposed to MDMA and psilocybin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121522 0
Prof Paul Fitzgerald
Address 121522 0
Australian National University (ANU)
School of Medicine and Psychology
The Australian National University, Science Rd
Canberra, ACT
2601
Country 121522 0
Australia
Phone 121522 0
+61 2 6125 2796
Fax 121522 0
Email 121522 0
paul.fitzgerald@anu.edu.au
Contact person for public queries
Name 121523 0
Samantha Webb
Address 121523 0
Monarch Mental Health Group, Shop 2, 629 Canterbury Road, Surrey Hills Vic 3127.
Australia
Country 121523 0
Australia
Phone 121523 0
+61 1300 867 888
Fax 121523 0
Email 121523 0
monarchri_psychedelics@mmhg.com.au
Contact person for scientific queries
Name 121524 0
Prof Paul Fitzgerald
Address 121524 0
Australian National University (ANU)
School of Medicine and Psychology
The Australian National University, Science Rd
Canberra, ACT
2601
Country 121524 0
Australia
Phone 121524 0
+61 2 6125 2796
Fax 121524 0
Email 121524 0
paul.fitzgerald@anu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The PI has not yet decided whether IPD will be made available on public directories.


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.