NCT01400204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

2 months

First QC Date

July 21, 2011

Last Update Submit

July 21, 2011

Conditions

Keywords

hangovernext day effectsMDMAAlcohol

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • poly drug user
  • + years old

You may not qualify if:

  • mental or physical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Utrecht University

Utrecht, Utrecht, 3584CG, Netherlands

Location

Study Officials

  • Joris C Verster, PhD

    Utrecht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 22, 2011

Study Start

December 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations