Overview

This trial is active, not recruiting.

Condition healthy
Treatments lisdexamfetamine, d-amphetamine, placebo, d-amphetamine, placebo, lisdexamfetamine, placebo, lisdexamfetamine, d-amphetamine
Phase phase 1
Sponsor University Hospital, Basel, Switzerland
Start date May 2016
End date June 2016
Trial size 24 participants
Trial identifier NCT02668926, EKNZ 2015-00015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(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.
lisdexamfetamine, d-amphetamine, placebo Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate
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.
(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 Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate
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.
(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 Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate
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.

Primary Outcomes

Measure
Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones
time frame: 13 hours
Subjective effects of lisdexamphetamine and d-amphetamine
time frame: 13 hours

Secondary Outcomes

Measure
Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy
time frame: 1h

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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)

Additional Information

Official title Endocrine and Emotional Effects of Lisdexamfetamine and d- Amphetamine: a Placebo-controlled Study in Healthy Subjects (LisDexStudy)
Principal investigator Matthias E Liechti, MD, MAS
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland.