Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00895804 |
Recruitment Status :
Completed
First Posted : May 8, 2009
Last Update Posted : June 15, 2009
|
Sponsor:
University Hospital, Basel, Switzerland
Collaborator:
Heffter Research Institute
Information provided by:
University Hospital, Basel, Switzerland
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | May 7, 2009 | |||
First Posted Date ICMJE | May 8, 2009 | |||
Last Update Posted Date | June 15, 2009 | |||
Study Start Date ICMJE | June 2001 | |||
Actual Primary Completion Date | March 2002 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Effect of pindolol on subjective response to MDMA [ Time Frame: 24h ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Effect of pindolol on physiological response to MDMA [ Time Frame: 24h ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine) | |||
Official Title ICMJE | Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine) | |||
Brief Summary | MDMA (3,4-Methylenedioxymethamphetamine, "Ecstasy") produces tachycardia, hypertension, hyperthermia, and other acute adverse effects. Ecstasy use has also been associated with rare cardio- and cerebrovascular complications. The role of beta-blockers in the treatment of cardiovascular and adverse effects of MDMA is unknown. | |||
Detailed Description | We investigated the interactive effects of the beta-blocker pindolol (20 mg) with MDMA (1.6 mg/kg) on heart rate, blood pressure, body temperature, and adverse effects in a double-blind placebo-controlled study in 16 healthy subjects. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
|||
Condition ICMJE |
|
|||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
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 ICMJE | Completed | |||
Actual Enrollment ICMJE |
16 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2002 | |||
Actual Primary Completion Date | March 2002 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Switzerland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00895804 | |||
Other Study ID Numbers ICMJE | E-003/2001 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Matthias E. Liechti, Universtity Hospital Basel | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | University Hospital, Basel, Switzerland | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Heffter Research Institute | |||
Investigators ICMJE |
|
|||
PRS Account | University Hospital, Basel, Switzerland | |||
Verification Date | June 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |