Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000884606
Ethics application status
Approved
Date submitted
11/06/2023
Date registered
17/08/2023
Date last updated
17/08/2023
Date data sharing statement initially provided
17/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional, cognitive and behavioural effects of 5-MeO-DMT administered by intramuscular injection
Scientific title
Effects of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) administered by intramuscular injection on frequency oscillatory power bands in healthy adults
Secondary ID [1] 309516 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 329914 0
Condition category
Condition code
Mental Health 326704 326704 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study employs a single-blind design (only the researchers will know the dosing regimen) involving 15 healthy volunteers. Following successful screening, and after consent is obtained, there will be 4 dosing days, each spaced 2 weeks apart. The four dosing days will involve IM administration of 5-MeO-DMT (3 mg, 6 mg and 9 mg) and inactive placebo. A psychiatrist/medical practitioner will administer the intervention.
Intervention code [1] 325952 0
Behaviour
Intervention code [2] 326414 0
Treatment: Drugs
Comparator / control treatment
On one of the 4 dosing sessions, each participant will be administered an inactive placebo (i.e., saline).
Control group
Placebo

Outcomes
Primary outcome [1] 334568 0
Acute and post-acute effects of IM administered 5-MeO-DMT or placebo on frequency oscillatory power bands (during eyes closed) as assessed by magnetoencephalography (MEG).
Timepoint [1] 334568 0
On the dosing day there will be an 8 minute baseline recording with MEG prior to IM administration of 5-Meo-DMT or placebo. After this there will be a 60 min MEG recording to ascertain the acute effects. After this, we will do a post-acute recording of 8 minutes. This would be repeated for all 4 dosing days.
Secondary outcome [1] 421250 0
Post-acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on human neurobiological activity, predominantly assessed via neural functional connectivity obtained during a 12-minute resting-state and 6-minute anatomical fMRI scan post-acute each dose.
Timepoint [1] 421250 0
The fMRI assessment will be conducted 90 minutes post administration of IM 5-MeO-DMT or placebo. This will be repeated for all 4 dosing days.
Secondary outcome [2] 423472 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on emotional regulation using the Difficulties in Emotion Regulation Scale (DERS), Gratz, K.L. and L. Roemer. Journal of Psychopathology and Behavioral Assessment, (2004). 26(1): 41-54.
Timepoint [2] 423472 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [3] 423473 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on decentering using the Decentering Questionnaire (DQ). Fresco, D.M., et al., Behavior Therapy, (2007) 38(3): 234-246.
Timepoint [3] 423473 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [4] 424167 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on suggestibility using the Short Suggestibility Scale (SSS). Kotov, R., S.B. Bellman, and D.B. Watson. Multidimensional Iowa Suggestibility Scale (MISS) Brief Manual. 2004.
Timepoint [4] 424167 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [5] 424168 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on social desirability using the Marlowe–Crowne Social Desirability Scale (MCSD) – Short version. Ballard, R., Psychological reports, (1992) 71(3_suppl): 1155-1160.
Timepoint [5] 424168 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [6] 424169 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on resilience using the Brief Resilience Scale (BRS). Smith, B. W., Dalen, J., Wiggins, K., Tooley, E., Christopher, P., & Bernard, J. (2008). The brief resilience scale: assessing the ability to bounce back. International journal of behavioral medicine, 15, 194-200.
Timepoint [6] 424169 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [7] 424170 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on interoceptive awareness using the Multidimensional Assessment of Interoceptive Awareness (MAIA). Mehling, W.E., et al., The multidimensional assessment of interoceptive awareness (MAIA). PloS one, 2012.
Timepoint [7] 424170 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [8] 424171 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on satisfaction with life using the Satisfaction with Life Scale (SLS). Diener, E., et al., J. Pers. Assess, (1985) 49(1): 71-5.
Timepoint [8] 424171 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [9] 424172 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on symptoms of depression, anxiety and stress using the Depression, Anxiety, Stress Scale 21 (DASS-21). Henry, J.D. and J.R. Crawford, British Journal of Clinical Psychology, (2005) 44(2): 227-239.

Note, symptoms of depression, anxiety and stress will be assessed in a composite outcome.
Timepoint [9] 424172 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [10] 424173 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on mindfulness using the Five Facets Mindfulness Questionnaire 39 (FFMQ-39). Baer, R.A., et al., Assessment, (2008) 15(3): 329-342.
Timepoint [10] 424173 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [11] 424174 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on self-regulation using the Short Form Self-Regulation Questionnaire (SSRQ). Brown, J.M., W.R. Miller, and L.A. Lawendowski, The self-regulation questionnaire. 1999.
Timepoint [11] 424174 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [12] 424175 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on spiritual bypassing using the Spiritual Bypass Scale 13 (SBS-13). Fox, J., C.S. Cashwell, and G. Picciotto, Spirituality in Clinical Practice, (2017) 4(4): 274.
Timepoint [12] 424175 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [13] 424176 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on somatic symptoms using the Somatic Symptoms Scale (SSS-8). Gierk, B., et al., JAMA Internal Medicine, (2014) 174(3): 399-407.
Timepoint [13] 424176 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [14] 424177 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on a range of sleep measures (i.e., Getting to sleep - GTS ) using the Leeds Sleep Evaluation Questionnaire (LSEQ). Carhart-Harris, R.L., et al., The Lancet Psychiatry, 2016(8).
Timepoint [14] 424177 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [15] 424178 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on gratitude using the The Gratitude Questionnaire-Six Item Form (GQ-6). Johnson, M.W., et al., Journal of Psychopharmacology, 2014: p. 0269881114548296.
Timepoint [15] 424178 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [16] 424179 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on personality using the Ten Item Personality Inventory. Gosling, S.D., P.J. Rentfrow, and W.B. Swann Jr, Journal of Research in Personality, (2003) 37(6): 504-528.
Timepoint [16] 424179 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [17] 424180 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on physical symptoms using the Physical Symptoms Inventory (PSI). Spector, P. E., & Jex, S. M. (1997). Physical Symptoms Inventory. Journal of Occupational Health Psychology.
Timepoint [17] 424180 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [18] 424181 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on occurrence of hallucinogen persisting perception disorder (HPPD) using the Hallucinogen Persisting Perception Disorder – Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (DSM-5®). American Psychiatric Pub.
Timepoint [18] 424181 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [19] 424182 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on reactivation using a self-constructed 8-item questionnaire.
Timepoint [19] 424182 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [20] 424183 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on experience of adverse psychological effects (for example increased anxiety or psychological distress), using a self-constructed 2-item questionnaire.
Timepoint [20] 424183 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [21] 424184 0
Acute effects of IM-administered 5-MeO-DMT or placebo on resting state cognition using the Amsterdam Resting State Questionnaire. Diaz, B.A., et al., Frontiers in Human Neuroscience, (2013) 7: 446.
Timepoint [21] 424184 0
Following fMRI post-acute IM administration of 5-MeO-DMT OR placebo on each dosing day.
Secondary outcome [22] 424185 0
Acute effects of IM-administered 5-MeO-DMT or placebo on degree of challenge of experience using the Challenging Experience Questionnaire (CEQ). Barrett, F.S., et al., The Challenging Experience Questionnaire: Characterization of challenging experiences with psilocybin mushrooms. Journal of Psychopharmacology, 2016. 30(12): p. 1279-1295.
Timepoint [22] 424185 0
Following fMRI post-acute IM administration of 5-MeO-DMT OR placebo on each dosing day.
Secondary outcome [23] 424186 0
Acute effects of IM-administered 5-MeO-DMT or placebo on mystical experience using the Mystical Experience Questionnaire (MEQ). Barrett, F.S., M.W. Johnson, and R.R. Griffiths, Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin. Journal of Psychopharmacology, 2015. 29(11): p. 1182-1190.
Timepoint [23] 424186 0
Following fMRI post-acute IM administration of 5-MeO-DMT OR placebo on each dosing day.
Secondary outcome [24] 424187 0
Acute effects of IM-administered 5-MeO-DMT or placebo on ego dissolution using the Ego Dissolution Inventory (EDI). Nour, M.M., et al., Frontiers in Human Neuroscience, (2016) 10: 269
Timepoint [24] 424187 0
Following fMRI post-acute IM administration of 5-MeO-DMT OR placebo on each dosing day.
Secondary outcome [25] 424188 0
Acute effects of IM-administered 5-MeO-DMT or placebo on acceptance promoting experience using the Acceptance/Avoidance-Promoting Experience Questionnaire Short Version (APEQ). Wolff, M., et al., Journal of Psychopharmacology, (2022) 36(3): 387-408.
Timepoint [25] 424188 0
Following fMRI post-acute IM administration of 5-MeO-DMT OR placebo on each dosing day.
Secondary outcome [26] 424189 0
Acute effects of IM-administered 5-MeO-DMT or placebo on emotional breakthrough using the Emotional Breakthrough Inventory (EBI). Roseman, L., et al., Journal of Psychopharmacology, (2019) 33(9): 1076-1087.
Timepoint [26] 424189 0
Following fMRI post-acute IM administration of 5-MeO-DMT OR placebo on each dosing day.
Secondary outcome [27] 424190 0
Acute effects of IM-administered 5-MeO-DMT or placebo on experiences of love using a self-constructed 7-item questionnaire.
Timepoint [27] 424190 0
Following fMRI post-acute IM administration of 5-MeO-DMT OR placebo on each dosing day.
Secondary outcome [28] 424191 0
Acute effects of IM-administered 5-MeO-DMT or placebo on somatic experiences using a self-constructed 11-item questionnaire.
Timepoint [28] 424191 0
Following fMRI post-acute IM administration of 5-MeO-DMT OR placebo on each dosing day.
Secondary outcome [29] 424192 0
Safety profile during and post-acute IM administration of 5-MeO-DMT/placebo using pharmacokinetic parameters. Specifically plasma will be drawn to ascertain pharmacokinetics (i.e., ratio of 5-MeO-DMT and bufotenine).
Timepoint [29] 424192 0
During acute IM administration of 5-MeO-DMT OR placebo and following fMRI post-acute IM administration of 5-MeO-DMT OR placebo on each dosing day.
T0,T5,T10,T15,T20,T25,T30,T40,T50,T60,T90,T120 =
0, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90 and 120 minutes post IM-administration of 5-MeO-DMT OR placebo.
Secondary outcome [30] 425369 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on a range of sleep measures (i.e., quality of sleep – QOS ) using the Leeds Sleep Evaluation Questionnaire (LSEQ). Carhart-Harris, R.L., et al., The Lancet Psychiatry, 2016(8).
Timepoint [30] 425369 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [31] 425370 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on a range of sleep measures (i.e., awakening from sleep - AFS) using the Leeds Sleep Evaluation Questionnaire (LSEQ). Carhart-Harris, R.L., et al., The Lancet Psychiatry, 2016(8).
Timepoint [31] 425370 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [32] 425371 0
Acute and cumulative effects of IM-administered 5-MeO-DMT or placebo on a range of sleep measures (i.e., behaviour following wakefulness BFW) using the Leeds Sleep Evaluation Questionnaire (LSEQ). Carhart-Harris, R.L., et al., The Lancet Psychiatry, 2016(8).
Timepoint [32] 425371 0
Baseline relative to 3 days after each dosing session, then at 1 month and 3 months post completion of the IM administration series of 5-MeO-DMT or placebo.
Secondary outcome [33] 425372 0
Acute effects of IM-administered 5-MeO-DMT or placebo on avoidance-promoting experience using the Acceptance/Avoidance-Promoting Experience Questionnaire Short Version (APEQ). Wolff, M., et al., Journal of Psychopharmacology, (2022) 36(3): 387-408.
Timepoint [33] 425372 0
Following fMRI post-acute IM administration of 5-MeO-DMT OR placebo on each dosing day.

Eligibility
Key inclusion criteria
Physically and mentally healthy.
Good command of the English language.
Prior experience with a psychedelic without experiencing adverse events.
Normal baseline ECG (determined by study medic).
Informed consent.
No psychedelic use within 2 weeks prior to the experiment.
Email access.
No anaemia.
Normal healthy body mass index (i.e., between 18.5-24.9).
Not use caffeine or nicotine 2 hours before or 6 hours after the dose.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not physically and mentally healthy.
No command of the English language.
No prior experience with a psychedelic without experiencing adverse events.
Abnormal baseline ECG (determined by study medic).
No informed consent.
Psychedelic use within 2 weeks prior to the experiment.
No email access.
Anaemia.
Abnormal body mass index (i.e., below 18,5 or above 24,9).
Not use caffeine or nicotine 2 hours before or 6 hours after the dose.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive and well-being data will be represented by descriptive statistics.

After any transformations required to make assumptions of normality, valid repeated measures mixed model analysis will be used for baseline comparisons with all MEG and fMRI variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313710 0
Charities/Societies/Foundations
Name [1] 313710 0
Psychedelic Research in Science & Medicine (PRISM) Ltd
Country [1] 313710 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology, Hawthorn
Address
John St, Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 315527 0
None
Name [1] 315527 0
None
Address [1] 315527 0
None
Country [1] 315527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312883 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 312883 0
John St, Hawthorn, VIC 3122
Ethics committee country [1] 312883 0
Australia
Date submitted for ethics approval [1] 312883 0
Approval date [1] 312883 0
17/07/2022
Ethics approval number [1] 312883 0

Summary
Brief summary
This study aims to improve the scientific understanding of the effects of intramuscularly (IM) administered 5-MeO-DMT on human brain activity as well as other indexes of well-being as assessed through psychological, physiological, and biological markers. Finally, we aim to further our understanding of the tolerability and safety profile as well as dose-dependent effects of different doses of 5-MeO-DMT or placebo administered per intramuscular administration and to uncover its phenomenological characteristics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126210 0
Prof Susan Rossell
Address 126210 0
Swinburne University of Technology, John St, Hawthorn, VIC 3122
Country 126210 0
Australia
Phone 126210 0
+61 3 9214 8173
Fax 126210 0
Email 126210 0
srossell@swin.edu.au
Contact person for public queries
Name 126211 0
Prof Susan Rossell
Address 126211 0
Swinburne University of Technology, John St, Hawthorn, VIC 3122
Country 126211 0
Australia
Phone 126211 0
+61 3 9214 8173
Fax 126211 0
Email 126211 0
srossell@swin.edu.au
Contact person for scientific queries
Name 126212 0
Prof Susan Rossell
Address 126212 0
Swinburne University of Technology, John St, Hawthorn, VIC 3122
Country 126212 0
Australia
Phone 126212 0
+61 3 9214 8173
Fax 126212 0
Email 126212 0
srossell@swin.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
Due to potential for identification of participants given the large volume of personal characteristics as well as contractual agreements with grant providers, we will not be sharing individual participant data for this trial.


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.