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Naturalistic Study Into the Hangover Effects of MDMA

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ClinicalTrials.gov Identifier: NCT01400204
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : July 22, 2011
Sponsor:
Information provided by:
Utrecht Institute for Pharmaceutical Sciences

Tracking Information
First Submitted Date July 21, 2011
First Posted Date July 22, 2011
Last Update Posted Date July 22, 2011
Study Start Date December 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Naturalistic Study Into the Hangover Effects of MDMA
Official Title A Naturalistic Study Comparing the Hangover Effects of MDMA, Other Drugs, and Alcohol in a Sample of Recreational Polydrug Users
Brief Summary 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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Recreational poly-drug users who were guests at a privat New Years Eve party
Condition Hangover
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July¬†21,¬†2011)
39
Original Actual Enrollment Same as current
Actual Study Completion Date February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • poly drug user
  • 18+ years old

Exclusion Criteria:

  • mental or physical illness
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01400204
Other Study ID Numbers ppo-010-212
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Joris C Verster, PhD, Utrecht University
Study Sponsor Utrecht Institute for Pharmaceutical Sciences
Collaborators Not Provided
Investigators
Principal Investigator: Joris C Verster, PhD Utrecht University
PRS Account Utrecht Institute for Pharmaceutical Sciences
Verification Date July 2011