Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine]

NCT ID: NCT00823407

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the pharmacological and cognitive effects of MDA in healthy humans.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MDA

Group Type OTHER

MDA

Intervention Type DRUG

subjects will receive a single oral dose of MDA 98mg/70kg body weight

Placebo

Intervention Type DRUG

Subjects will receive a single oral dose of placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MDA

subjects will receive a single oral dose of MDA 98mg/70kg body weight

Intervention Type DRUG

Placebo

Subjects will receive a single oral dose of placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John Mendelson, MD

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John E Mendelson, MD

Role: PRINCIPAL_INVESTIGATOR

CPMC Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CPMC Addiction & Pharmacology Research Laboratory (APRL)

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 21152030 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IND# 79,632

Identifier Type: -

Identifier Source: secondary_id

5R01DA016776

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHR# H6637-31759-01

Identifier Type: -

Identifier Source: secondary_id

IRB# 27.112

Identifier Type: -

Identifier Source: secondary_id

RAP-C# 0740

Identifier Type: -

Identifier Source: secondary_id

27.112

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Stimulant Effects on Brain Activity
NCT02453698 COMPLETED PHASE1