This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00823407
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : May 31, 2013
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Information provided by (Responsible Party):
John Mendelson, MD, California Pacific Medical Center Research Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans.

Condition or disease Intervention/treatment Phase
Healthy Drug: MDA Drug: Placebo Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]
Study Start Date : January 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823407


Locations
Layout table for location information
United States, California
CPMC Addiction & Pharmacology Research Laboratory (APRL)
San Francisco, California, United States, 94110
Sponsors and Collaborators
California Pacific Medical Center Research Institute
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: John E Mendelson, MD CPMC Research Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Layout table for additonal information
Responsible Party: John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00823407    
Other Study ID Numbers: 27.112
IND# 79,632
5R01DA016776 ( U.S. NIH Grant/Contract )
CHR# H6637-31759-01
IRB# 27.112
RAP-C# 0740
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013
Keywords provided by John Mendelson, MD, California Pacific Medical Center Research Institute:
MDA
MDMA
Ecstasy
entactogen
 pharmacokinetics
pharmacodynamics
Pharmacokinetics and pharmacodynamics of MDA studies in healthy volunteers