Mood Disorder, Substance-Related Disorders, Amphetamine-Related Disorders
Conditions
Keywords
MDMA, beta adrenergic, Ecstasy
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.
Interventions
DRUGMDMA
capsule, 1.6 mg/kg body weight, single dose
DRUGPindolol
capsule of 20mg pindolol, single dose 1h before MDMA
Sponsors
Heffter Research Institute
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of pindolol on subjective response to MDMA | 24h |
Secondary
| Measure | Time frame |
|---|---|
| Effect of pindolol on physiological response to MDMA | 24h |
Countries
Switzerland
Outcome results
None listed