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CompletedNCT00823407MDAUpdated May 31, 2013

Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]

An interventional study of MDA and Placebo in Healthy, sponsored by California Pacific Medical Center Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-31.

Sponsored by California Pacific Medical Center Research Institute · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans.

02

Conditions studied

  • Healthy

Keywords

  • MDA
  • MDMA
  • Ecstasy
  • entactogen
  • pharmacokinetics
  • pharmacodynamics
  • Pharmacokinetics and pharmacodynamics of MDA studies in healthy volunteers
03

In context

Lead sponsor

California Pacific Medical Center Research Institute is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy males and females age 18-50
  • Fluent English speaker
  • Willing and able to give written consent

Exclusion criteria

Exclusion Criteria:

  • Body mass index > 30 or \< 18
  • Pregnancy or lactation

FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Care provider)
Enrollment
12 participants (actual)

Study arms

  • Other
    MDA

    Drug: MDA · Drug: Placebo

Interventions

  • DrugMDA

    subjects will receive a single oral dose of MDA 98mg/70kg body weight

  • DrugPlacebo

    Subjects will receive a single oral dose of placebo

06

What researchers measure

Primary outcomes

  1. MDA will be metabolized to hydroxyamphetamine (HMA) and dihydroxyamphetamine (DHA) and will produce dose-dependent increases in neuroendocrine measures.

    Time frame: 0-48 hours post dose

Secondary outcomes

  1. MDA will produce dose-dependent increases in self-report entactogen-like and stimulant like measures.

    Time frame: 0-48 hours post dose

07

Study locations

1 site
  • CPMC Addiction & Pharmacology Research Laboratory (APRL)
    San Francisco, California 94110, United States
08

References and documents

Publications

  • Baggott MJ, Siegrist JD, Galloway GP, Robertson LC, Coyle JR, Mendelson JE. Investigating the mechanisms of hallucinogen-induced visions using 3,4-methylenedioxyamphetamine (MDA): a randomized controlled trial in humans. PLoS One. 2010 Dec 2;5(12):e14074. doi: 10.1371/journal.pone.0014074. PubMed 21152030 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00823407
Lead sponsor
California Pacific Medical Center Research Institute
Collaborators
National Institute on Drug Abuse (NIDA), University of California, San Francisco
Responsible party
John Mendelson, MD (Senior Scientist, California Pacific Medical Center Research Institute) — Principal investigator
First posted
Jan 15, 2009
Start date
Jan 2009
Primary completion
Jul 2009
Completion
Jul 2009
Last update
May 31, 2013

Study contacts

John E Mendelson, MD
principal investigator · CPMC Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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