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Trial record 3 of 71374 for:    pharmacology

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823407
First Posted: January 15, 2009
Last Update Posted: May 31, 2013
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.
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
  Purpose
The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans.

Condition Intervention
Healthy Drug: MDA Drug: Placebo

Study Type: Interventional
Study Design: 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]

Further study details as provided by John Mendelson, MD, California Pacific Medical Center Research Institute:

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

Enrollment: 12
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


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
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
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
Principal Investigator: John E Mendelson, MD CPMC Research Institute
  More Information

Additional Information:
Publications:
Responsible Party: John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00823407     History of Changes
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 Submitted: January 14, 2009
First Posted: January 15, 2009
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

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
3,4-Methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents