Healthy
Conditions
Brief summary
The study will compare the acute emotional and endocrine effects of equivalent doses of lisdexamfetamine and amphetamine in healthy subjects. In addition the pharmacokinetics and effects of the amphetamines on aspects of social cognition are investigated.
Interventions
DRUGLisdexamfetamine, d-amphetamine, Placebo
Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.
DRUGd-amphetamine, Placebo, Lisdexamfetamine
Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.
DRUGPlacebo, Lisdexamfetamine, d-amphetamine
Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.
Sponsors
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
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
healthy subjects aged 18-45 years
Exclusion criteria
1. Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. 2. Current or previous psychotic or major affective disorder 3. Psychotic or major affective disorder in first-degree relatives 4. Prior illicit drug use (cannabis) more than 5 times or any time within the previous 2 months. 5. Pregnant or nursing women. 6. Participation in another clinical trial (currently or within the last 30 days) 7. Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.) 8. Tobacco smoking (\>10 cigarettes/day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones | 13 hours | Measurement of different circulating hormones before and after drug |
| Subjective effects of lisdexamphetamine and d-amphetamine | 13 hours | Assessment of subjective effects using visual analog scales |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy | 1h | Assessment of emotion recognition and empathy using different Computer Tasks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | 13h | Collection of blood samples for measurement of plasma concentrations |
Countries
Switzerland
Outcome results
None listed