The role of the 5-HT2a receptor in MDMA-induced effects on social cognition and prosocial behaviour
Double-blind, placebo-controlled crossover trial (n=24) testing the role of the 5-HT2a receptor in MDMA-induced effects on social behaviour (MDMA 75 mg; ketanserin 40 mg; combination; placebo).
Detailed Description
Randomised, double-blind, placebo-controlled within-subject crossover with four test days (minimum 7-day washout) comparing MDMA 75 mg, ketanserin 40 mg, the combination, and placebo in healthy volunteers.
Primary outcomes assess cognitive and affective empathy measures and tasks; secondary outcomes include social interaction and attitude tasks, memory, and drug and hormone concentrations in blood. Total participant burden approximately 18 hours over a minimum of 5 weeks.
Study Protocol
Preparation
Dosing
Integration
Study Arms & Interventions
MDMA/ketanserin/placebo crossover
experimentalWithin-subject crossover with four conditions: MDMA 75 mg; ketanserin 40 mg; MDMA 75 mg + ketanserin 40 mg; placebo.
Interventions
- MDMA75 mgvia Oral• single dose
MDMA 75 mg capsule
- Compound40 mgvia Oral• single dose
Ketanserin 40 mg capsule (active comparator) — given alone or before MDMA in combination condition
- Placebovia Oral• single dose
Matching placebo capsule
Participants
Inclusion Criteria
- Healthy volunteers aged 18–35 years who have used MDMA/ecstasy between 3 and 200 times lifetime and at least once in the past year.
Exclusion Criteria
- Never used ecstasy/MDMA.
Study Details
- StatusCompleted
- PhasePhase NA
- Typeinterventional
- DesignRandomizeddouble Blind
- Target Enrollment24 participants
- TimelineStart: 2013-01-23End: 2015-01-01
- Compounds
- Topic