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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: MDA Drug: Placebo | Not Applicable |
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 |
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 |
- 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 ]
- MDA will produce dose-dependent increases in self-report entactogen-like and stimulant like measures. [ Time Frame: 0-48 hours post dose ]
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 |
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.
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
United States, California | |
CPMC Addiction & Pharmacology Research Laboratory (APRL) | |
San Francisco, California, United States, 94110 |
Principal Investigator: | John E Mendelson, MD | CPMC Research Institute |
Publications of Results:
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 |
MDA MDMA Ecstasy entactogen |
pharmacokinetics pharmacodynamics Pharmacokinetics and pharmacodynamics of MDA studies in healthy volunteers |