Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine] (MDA)

May 29, 2013 updated by: John Mendelson, MD, California Pacific Medical Center Research Institute
The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: MDA
Drug: MDA
subjects will receive a single oral dose of MDA 98mg/70kg body weight
Drug: Placebo
Subjects will receive a single oral dose of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0-48 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
MDA will produce dose-dependent increases in self-report entactogen-like and stimulant like measures.
Time Frame: 0-48 hours post dose
0-48 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Collaborators

National Institute on Drug Abuse (NIDA)
University of California, San Francisco

Investigators

  • Principal Investigator: John E Mendelson, MD, CPMC Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (ESTIMATE)

January 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 27.112
  • IND# 79,632
  • 5R01DA016776 (NIH)
  • CHR# H6637-31759-01
  • IRB# 27.112
  • RAP-C# 0740

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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