NCT00823407

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

January 14, 2009

Last Update Submit

May 29, 2013

Conditions

Healthy

Keywords

MDAMDMAEcstasyentactogenpharmacokineticspharmacodynamicsPharmacokinetics and pharmacodynamics of MDA studies in healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

    0-48 hours post dose

Secondary Outcomes (1)

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

    0-48 hours post dose

Study Arms (1)

MDA

OTHER
Drug: MDADrug: Placebo

Interventions

MDADRUG

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

MDA
PlaceboDRUG

Subjects will receive a single oral dose of placebo

MDA

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Body mass index \> 30 or \< 18
  • Pregnancy or lactation
  • FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPMC Addiction & Pharmacology Research Laboratory (APRL)

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • 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.

    PMID: 21152030RESULT

Related Links

Study Officials

  • John E Mendelson, MD

    CPMC Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 15, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

US(1)