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NCT01400204 Clinical Trial

Naturalistic Study Into the Hangover Effects of MDMA

Hangover Clinical Trial

Official title:
A Naturalistic Study Comparing the Hangover Effects of MDMA, Other Drugs, and Alcohol in a Sample of Recreational Polydrug Users

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01400204
Other study ID # ppo-010-212
Secondary ID
Status Completed
Phase N/A
First received July 21, 2011
Last updated July 21, 2011
Start date December 2010
Est. completion date February 2011

Study information
Verified date July 2011
Source Utrecht Institute for Pharmaceutical Sciences
Contact n/a
Is FDA regulated No
Health authority Netherlands: Independent Ethics Committee
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- poly drug user

- 18+ years old

Exclusion Criteria:

- mental or physical illness

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Utrecht University Utrecht

Sponsors (1)
Lead Sponsor Collaborator
Utrecht Institute for Pharmaceutical Sciences

Country where clinical trial is conducted

Netherlands,