Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Naturalistic Study Into the Hangover Effects of MDMA

This study has been completed.
Sponsor:
Information provided by:
Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT01400204
First received: July 21, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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.


Condition
Hangover

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Naturalistic Study Comparing the Hangover Effects of MDMA, Other Drugs, and Alcohol in a Sample of Recreational Polydrug Users

Further study details as provided by Utrecht Institute for Pharmaceutical Sciences:

Enrollment: 39
Study Start Date: December 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
MDMA
poly drug users that used MDMA at New Years Eve
Other Drugs
poly drug users that used drugs at New Years Eve, but not MDMA
Alcohol
poly drug users that used no drugs at New Years Eve, but did consume alcohol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Recreational poly-drug users who were guests at a privat New Years Eve party

Criteria

Inclusion Criteria:

  • poly drug user
  • 18+ years old

Exclusion Criteria:

  • mental or physical illness
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400204

Locations
Netherlands
Utrecht University
Utrecht, Netherlands, 3584CG
Sponsors and Collaborators
Utrecht Institute for Pharmaceutical Sciences
Investigators
Principal Investigator: Joris C Verster, PhD Utrecht University
  More Information

No publications provided

Responsible Party: Joris C Verster, PhD, Utrecht University
ClinicalTrials.gov Identifier: NCT01400204     History of Changes
Other Study ID Numbers: ppo-010-212
Study First Received: July 21, 2011
Last Updated: July 21, 2011
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
hangover
next day effects
MDMA
Alcohol

ClinicalTrials.gov processed this record on November 27, 2014