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RecruitingACTRN12622001315707

Safety study of safety, tolerability, and subjective effects of two dimethyltryptamine (DMT) and harmala alkaloid containing formulations in Depression; Addiction; Trauma

The registry lists this study as recruiting. Study locations are listed in Australia. Confirm recruitment at each site. It is testing safety, tolerability, and subjective effects of two dimethyltryptamine (DMT) and harmala alkaloid containing formulations for Depression; Addiction; Trauma.

Addiction, Depression, ...DrugFrom 25 Years to 70 Years
In plain English

Key information made simple

What the source says

The registry describes this research topic: “An open label study to evaluate the safety, tolerability, and subjective effects of two dimethyltryptamine (DMT) and harmala alkaloid containing formulations in healthy volunteers”. This is an interventional study. The registry lists a target sample size of 8. Recruitment status at the registry update of 2023-02-02: recruiting. Read the original description and eligibility criteria, and confirm the practical details with the study team.

What should you check before joining?

Check the full criteria in the official source. Ask the team to confirm recruitment, locations, visits, risks and participation requirements.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateDecember 21, 2022
Recruitment status
Recruiting
Enrollment listed in the registry
8
Sponsor
St Vincent's Hospital, Melbourne
Sponsor type
Hospital / academic medical center
Study type
Drug
Intervention type
Medication / drug, Treatment: Other
Study phase
Phase 1Usually an early study focused on safety, tolerability, dosage, and side effects.
Locations
Australia
Age range
From 25 Years to 70 Years
Official registry ID
ACTRN12622001315707
Official title
AEOS: An open label study to evaluate the safety, tolerability, and subjective effects of two dimethyltryptamine (DMT) and harmala alkaloid containing formulations in healthy volunteers

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Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Australia · 1 site
  • St Vincent's Hospital (Melbourne) Ltd
    Fitzroy
    Site status: Not listed — confirm with the team
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with addiction. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study. Phase 1 studies usually focus mainly on safety, tolerability, dosage, and side effects. They often involve healthy volunteers, but not always. Some Phase 1 studies include people living with the target condition.

Are there criteria about substance use or wanting to reduce it?

The public registry appears to mention tobacco, nicotine, alcohol, cannabis, or another addiction-related topic. Ask the study team whether you need to want to stop, reduce, already be abstinent, or simply meet use-related criteria. Eligibility must be confirmed by the study team.

Does a loved one or caregiver need to be involved?

The public registry appears to mention a loved one, caregiver, or family involvement. Ask whether that person must participate, provide information, attend visits, or simply be available if needed. The study team must confirm what is required.

Will I need to change, stop, or stabilize my current treatment?

The public registry appears to mention rules about current treatment, stability, stopping treatment, or dose changes. Do not change your treatment for a study without medical guidance. Ask the study team and your clinician what is required, what is not allowed, and how safety is monitored.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by St Vincent's Hospital, Melbourne, which appears to be a hospital or academic medical center. The listed contact or investigator is Amanda Norman. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as recruiting. Individual sites may have different statuses. The research team must confirm whether a site is open and whether you meet the criteria.

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