Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)

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; (submitted: May 7, 2009)	Effect of pindolol on subjective response to MDMA [ Time Frame: 24h ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00895804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 7, 2009)	Effect of pindolol on physiological response to MDMA [ Time Frame: 24h ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	Mood Disorder; Substance-Related Disorders; Amphetamine-Related Disorders
Intervention ICMJE	Drug: MDMA capsule, 1.6 mg/kg body weight, single dose; Drug: Pindolol capsule of 20mg pindolol, single dose 1h before MDMA
Study Arms	Pindolol, Placebo Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject. Interventions: Drug: MDMA Drug: Pindolol; MDMA, Placebo Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two (actually 4) treatment conditions in the same subject. Interventions: Drug: MDMA Drug: Pindolol
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; (submitted: May 7, 2009)	16
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2002
Actual Primary Completion Date	March 2002 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Sufficient understanding of the German language; Subjects understand the procedures and the risks associated with the study; Participants must be willing to adhere to the protocol and sign the consent form; Participants must be willing to refrain from taking illicit psychoactive substances during the study.; Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids after midnight of the evening before the study session.; Participants must be willing not to drive a traffic vehicle in the evening of the study day.; Body mass index: 18-25 kg/m2 Exclusion Criteria: Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.; Current or previous psychotic or affective disorder; Psychotic or affective disorder in first-degree relatives; Prior illicit drug use (except THC-containing products) more than 5 times or any time within the previous 2 months.; Participation in another clinical trial (currently or within the last 30 days); Use of medications that are contraindicated or otherwise interfere with the effects of the study medications.
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years to 45 Years (Adult)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	Matthias E. Liechti, Universtity Hospital Basel
Study Sponsor ICMJE	University Hospital, Basel, Switzerland
Collaborators ICMJE	Heffter Research Institute
Investigators ICMJE	Principal Investigator: Matthias E Liechti, MD University Hospital, Basel, Switzerland
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