Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]

This study has been completed.
Sponsor:
Collaborators:
University of California, San Francisco
Information provided by (Responsible Party):
John Mendelson, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00823407
First received: January 14, 2009
Last updated: May 29, 2013
Last verified: May 2013
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of California, San Francisco
Investigators
Principal Investigator: John E Mendelson, MD CPMC Research Institute
  More Information

Additional Information:
No publications provided by California Pacific Medical Center Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, 5-R01-DA016776, CHR# H6637-31759-01, IRB# 27.112, RAP-C# 0740
Study First Received: January 14, 2009
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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:
3,4-Methylenedioxyamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Central Nervous System Agents
Hallucinogens
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014