Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.

Study Overview
=================
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.

Official Title
-----------------
Endocrine and Emotional Effects of Lisdexamfetamine and d- Amphetamine: a Placebo-controlled Study in Healthy Subjects (LisDexStudy)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Lisdexamfetamine, d-amphetamine, Placebo
* Drug: d-amphetamine, Placebo, Lisdexamfetamine
* Drug: Placebo, Lisdexamfetamine, d-amphetamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects aged 18-45 years Exclusion Criteria: Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. Current or previous psychotic or major affective disorder Psychotic or major affective disorder in first-degree relatives Prior illicit drug use (cannabis) more than 5 times or any time within the previous 2 months. Pregnant or nursing women. 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 (monoamine oxidase inhibitors, antidepressants, sedatives etc.) Tobacco smoking (>10 cigarettes/day)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lisdexamfetamine, d-amphetamine, Placebo<br>Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 3 arms with three treatment conditions in the same subject. The three treatment conditions are placebo, lisdexamfetamine, and d-Amphetamine sulfate. | Drug: Lisdexamfetamine, d-amphetamine, Placebo<br>* 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.<br>* Other names: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate;|
| Experimental: d-amphetamine, Placebo, Lisdexamfetamine<br>Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 3 arms with three treatment conditions in the same subject. The three treatment conditions are placebo, lisdexamfetamine, and d-Amphetamine sulfate. | Drug: d-amphetamine, Placebo, Lisdexamfetamine<br>* 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.<br>* Other names: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate;|
| Experimental: Placebo, Lisdexamfetamine, d-amphetamine<br>Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 3 arms with three treatment conditions in the same subject. The three treatment conditions are placebo, lisdexamfetamine, and d-Amphetamine sulfate. | Drug: Placebo, Lisdexamfetamine, d-amphetamine<br>* 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.<br>* Other names: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones | Measurement of different circulating hormones before and after drug | 13 hours | 
| Subjective effects of lisdexamphetamine and d-amphetamine | Assessment of subjective effects using visual analog scales | 13 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy | Assessment of emotion recognition and empathy using different Computer Tasks. | 1h |