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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

Tracking Information
First Submitted Date  ICMJE January 14, 2009
First Posted Date  ICMJE January 15, 2009
Last Update Posted Date May 31, 2013
Study Start Date  ICMJE January 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2011)		 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2009)
  • MDA will be metabolized to hydroxyamphetamine (HMA) and dihydroxyamphetamine (DHA). Urine is collected and analyzed for MDA and metabolites. [ Time Frame: 0-48 hrs. post dose ]
  • MDA dose-dependent increases in neuroendocrine measures assessed by cortisol, prolactin, and oxytocin levels. [ Time Frame: 0-48 hours post dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2011)		 MDA will produce dose-dependent increases in self-report entactogen-like and stimulant like measures. [ Time Frame: 0-48 hours post dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2009)
  • MDA will produce dose-dependent increases in self-report stimulant like measures assessed by AVI positive affect. [ Time Frame: 0-48 hours post dose ]
  • MDA dose-dependent increases in self-report entactogen-like measures assessed by IASR Affiliativeness [ Time Frame: 0-48 hours post dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]
Official Title  ICMJE Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]
Brief Summary The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE MDA
Interventions:
  • Drug: MDA
  • Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2009)		 12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00823407
Other Study ID Numbers  ICMJE 27.112
IND# 79,632
5R01DA016776 ( U.S. NIH Grant/Contract )
CHR# H6637-31759-01
IRB# 27.112
RAP-C# 0740
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party John Mendelson, MD, California Pacific Medical Center Research Institute
Original Responsible Party John E. Mendelson, MD, CPMC Research Institute
Current Study Sponsor  ICMJE California Pacific Medical Center Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • University of California, San Francisco
Investigators  ICMJE
Principal Investigator: John E Mendelson, MD CPMC Research Institute
PRS Account California Pacific Medical Center Research Institute
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP