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

• 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: May 7, 2009
• First Posted Date: May 8, 2009
• Last Update Posted Date: June 15, 2009
• Study Start Date: June 2001
• Actual Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 7, 2009): Effect of pindolol on subjective response to MDMA [ Time Frame: 24h ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: May 7, 2009): Effect of pindolol on physiological response to MDMA [ Time Frame: 24h ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine)
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science

Condition

• Mood Disorder
• Substance-Related Disorders
• Amphetamine-Related Disorders

Intervention

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2009): 16
• Original Actual Enrollment: 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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT00895804
• Other Study ID Numbers: E-003/2001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Matthias E. Liechti, Universtity Hospital Basel
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Basel, Switzerland
• Original Study Sponsor: Same as current
• Collaborators: Heffter Research Institute

Investigators

• Principal Investigator: Matthias E Liechti, MD; University Hospital, Basel, Switzerland

• PRS Account: University Hospital, Basel, Switzerland
• Verification Date: June 2009