HealthyMDANCT00823407
Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]
A study testing MDA in people with Healthy, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MDA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females age 18-50
- Fluent English speaker
- Willing and able to give written consent
Who cannot join
- Body mass index > 30 or < 18
- Pregnancy or lactation
- FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.
Trial locations and contacts
1 site in 1 country.
United States1 site
CPMC Addiction & Pharmacology Research Laboratory (APRL)
San Francisco, California, 94110
About this study
The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans.
- Conditions
- Healthy
- Being tested
- MDA, Placebo
- Keywords
- MDA, MDMA, Ecstasy, entactogen, pharmacokinetics, pharmacodynamics, Pharmacokinetics and pharmacodynamics of MDA studies in healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDADrug
subjects will receive a single oral dose of MDA 98mg/70kg body weight
PlaceboDrug
Subjects will receive a single oral dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| MDA | Other | Not described Receives: Drug: MDA; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDA will be metabolized to hydroxyamphetamine (HMA) and dihydroxyamphetamine (DHA) and will produce dose-dependent increases in neuroendocrine measures.
Measured: 0-48 hours post dose
Secondary outcomes (1)
MDA will produce dose-dependent increases in self-report entactogen-like and stimulant like measures.
Measured: 0-48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, San Francisco
- Responsible party
- Principal investigator, John Mendelson, MD, California Pacific Medical Center Research Institute
- Investigators
- John E Mendelson, MD, Principal investigator, CPMC Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823407
- Sponsor's protocol ID
- 27.112
- Other IDs
- IND# 79,632, 5R01DA016776, CHR# H6637-31759-01, IRB# 27.112, RAP-C# 0740
- Acronym
- MDA
- Status last verified
- May 2013
- First submitted
- 14 Jan 2009
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21152030
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]
- ClinicalTrials.gov ID
- NCT00823407
- Acronym / sponsor ID
- MDA / 27.112
- Conditions
- Healthy
- Keywords
- MDA, MDMA, Ecstasy, entactogen, pharmacokinetics, pharmacodynamics, Pharmacokinetics and pharmacodynamics of MDA studies in healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of California, San Francisco
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDA | Other | Drug: MDA, Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and females age 18-50
- Fluent English speaker
- Willing and able to give written consent
Key exclusion criteria (3 listed)
- Body mass index > 30 or < 18
- Pregnancy or lactation
- FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDAsubjects will receive a single oral dose of MDA 98mg/70kg body weight | Drug | MDA |
| PlaceboSubjects will receive a single oral dose of placebo | Drug | MDA |
Primary outcome
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
1 secondary outcome
MDA will produce dose-dependent increases in self-report entactogen-like and stimulant like measures.
Time frame: 0-48 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Results publication: PubMed 21152030Baggott 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.
- Addiction \& Pharmacology Research Laboratory webpageLink provided by the sponsor.
- PLoS ONELink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E Mendelson, MD principal investigator
CPMC Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDA in people with Healthy, run by California Pacific Medical Center Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00823407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.