- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01400204
Naturalistic Study Into the Hangover Effects of MDMA
July 21, 2011 updated by: Utrecht Institute for Pharmaceutical Sciences
A Naturalistic Study Comparing the Hangover Effects of MDMA, Other Drugs, and Alcohol in a Sample of Recreational Polydrug Users
The aim of the study is to compare hangover effects of MDMA users versus those who used other drugs, or alcohol only at New Year's Eve.
The week after New Years Eve, every day participants complete a questionnaire about the presence and severity of potential hangover symptoms.
At day 1, demographics and alcohol and drug use at New Years Eve were recorded.
On day 7, the Brief Symptom Inventory (BSI) is completed to asses last weeks mood.
After 4 weeks, after a drug-free week, the BSI is completed again to serve as a reference.
Study Overview
Status
Completed
Conditions
Detailed Description
A convenience sample was invited by e-mail to participate in the study, via the organizer of a private New Years Party.It was attempted to include as much participants as possible.
Hence, no sampling method was applied when recruiting participants.
Study Type
Observational
Enrollment (Actual)
39
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Utrecht, Netherlands, 3584CG
- Utrecht University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Recreational poly-drug users who were guests at a privat New Years Eve party
Description
Inclusion Criteria:
- poly drug user
- 18+ years old
Exclusion Criteria:
- mental or physical illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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MDMA
poly drug users that used MDMA at New Years Eve
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Other Drugs
poly drug users that used drugs at New Years Eve, but not MDMA
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Alcohol
poly drug users that used no drugs at New Years Eve, but did consume alcohol
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joris C Verster, PhD, Utrecht University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
July 21, 2011
First Submitted That Met QC Criteria
July 21, 2011
First Posted (Estimate)
July 22, 2011
Study Record Updates
Last Update Posted (Estimate)
July 22, 2011
Last Update Submitted That Met QC Criteria
July 21, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ppo-010-212
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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