Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine. (LisDex)

University Hospital Basel

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo, Lisdexamfetamine, d-amphetamine; Drug: d-amphetamine, Placebo, Lisdexamfetamine; Drug: Lisdexamfetamine, d-amphetamine, Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02668926

EKNZ 2015-00015

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

Lisdexamfetamine, d-amphetamine, Placebo

Experimental group

Description:

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.

Treatment:

Drug: Lisdexamfetamine, d-amphetamine, Placebo

d-amphetamine, Placebo, Lisdexamfetamine

Experimental group

Description:

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.

Treatment:

Drug: d-amphetamine, Placebo, Lisdexamfetamine

Placebo, Lisdexamfetamine, d-amphetamine

Experimental group

Description:

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.

Treatment:

Drug: Placebo, Lisdexamfetamine, d-amphetamine