Effects of Drugs on Responses to Brain and Emotional Processes
Randomized, triple-blind, crossover study (n=22) testing single oral MDMA 1.5 mg/kg versus placebo on affective touch responses across a range of autistic traits.
Detailed Description
Randomized, triple-blind, crossover design with two laboratory sessions 72 hours apart comparing single oral MDMA 1.5 mg/kg to placebo in adults aged 21–40.
Primary aim is basic science: to assess effects of MDMA on responses to affective touch across individuals with varying autistic traits; outcomes include behavioural and neural/emotional process measures.
Study Protocol
Preparation
Dosing
Integration
Study Arms & Interventions
Placebo → MDMA
experimentalParticipants receive placebo in first session and MDMA (1.5 mg/kg) 72 hours later (crossover).
Interventions
- Placebovia Oral• single dose
Placebo capsule containing lactose.
- MDMA1.5 mg/kgvia Oral• single dose• 1 doses total
Single oral MDMA 1.5 mg/kg.
MDMA → Placebo
experimentalParticipants receive MDMA (1.5 mg/kg) in first session and placebo 72 hours later (crossover).
Interventions
- MDMA1.5 mg/kgvia Oral• single dose• 1 doses total
Single oral MDMA 1.5 mg/kg.
- Placebovia Oral• single dose
Placebo capsule containing lactose.
Participants
Inclusion Criteria
- Inclusion Criteria:
- BMI between 19 and 30 (no one under 130 lbs)
- Smokers smoking less than 25 cigarettes per week
- Have used ecstasy no more than 40 times with no adverse responses.
Exclusion Criteria
- Exclusion Criteria:
- High blood pressure
- Any medical condition requiring regular medication
- Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
- Individuals with a history of dependence on stimulant drugs.
- Women who are pregnant or trying to become pregnant
Study Details
- StatusCompleted
- PhasePhase I
- Typeinterventional
- DesignRandomizedtriple Blind
- Target Enrollment22 participants
- TimelineStart: 2019-08-08End: 2021-04-12
- Compounds
- Topic