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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine, d-amphetamine, Placebo | Experimental | 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. |
|
| d-amphetamine, Placebo, Lisdexamfetamine | Experimental | 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. |
|
| Placebo, Lisdexamfetamine, d-amphetamine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine, d-amphetamine, Placebo | Drug | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Collection of blood samples for measurement of plasma concentrations | 13h |
Inclusion Criteria:
healthy subjects aged 18-45 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias E Liechti, MD, MAS | University Hospital, Basel, Switzerland | Principal Investigator |
| Alex Odermatt, Dr. | University of Basel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29511807 | Derived | Dolder PC, Strajhar P, Vizeli P, Odermatt A, Liechti ME. Acute effects of lisdexamfetamine and D-amphetamine on social cognition and cognitive performance in a placebo-controlled study in healthy subjects. Psychopharmacology (Berl). 2018 May;235(5):1389-1402. doi: 10.1007/s00213-018-4849-0. Epub 2018 Feb 9. | |
| 28936175 | Derived |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| D003913 | Dextroamphetamine |
| ID | Term |
|---|---|
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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|
| d-amphetamine, Placebo, Lisdexamfetamine | Drug | 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. |
|
|
| Placebo, Lisdexamfetamine, d-amphetamine | Drug | 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. |
|
|
| Dolder PC, Strajhar P, Vizeli P, Hammann F, Odermatt A, Liechti ME. Pharmacokinetics and Pharmacodynamics of Lisdexamfetamine Compared with D-Amphetamine in Healthy Subjects. Front Pharmacol. 2017 Sep 7;8:617. doi: 10.3389/fphar.2017.00617. eCollection 2017. |
| D000588 |
| Amines |
| D009930 | Organic Chemicals |