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

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ClinicalTrials.gov Identifier: NCT02668926
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lisdexamfetamine, d-amphetamine, Placebo Drug: d-amphetamine, Placebo, Lisdexamfetamine Drug: Placebo, Lisdexamfetamine, d-amphetamine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Endocrine and Emotional Effects of Lisdexamfetamine and d- Amphetamine: a Placebo-controlled Study in Healthy Subjects (LisDexStudy)
Study Start Date : May 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Lisdexamfetamine, d-amphetamine, Placebo
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
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.
Other Name: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate

Experimental: d-amphetamine, Placebo, Lisdexamfetamine
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
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.
Other Name: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate

Experimental: Placebo, Lisdexamfetamine, d-amphetamine
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
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.
Other Name: Lisdexamfetamine=Elvanse, d-amphetamine=d-amphetamine sulfate




Primary Outcome Measures :
  1. Effects of lisdexamphetamine and d-Amphetamine on circulating steroidal hormones [ Time Frame: 13 hours ]
    Measurement of different circulating hormones before and after drug

  2. Subjective effects of lisdexamphetamine and d-amphetamine [ Time Frame: 13 hours ]
    Assessment of subjective effects using visual analog scales


Secondary Outcome Measures :
  1. Effects of lisdexamphetamine and d-Amphetamine on emotion recognition and empathy [ Time Frame: 1h ]
    Assessment of emotion recognition and empathy using different Computer Tasks.


Other Outcome Measures:
  1. Pharmacokinetics [ Time Frame: 13h ]
    Collection of blood samples for measurement of plasma concentrations



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668926


Locations
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Switzerland
University Hospital Basel
Basel, Basel Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
Study Chair: Alex Odermatt, Dr. University of Basel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02668926     History of Changes
Other Study ID Numbers: EKNZ 2015-00015
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Amphetamine
Lisdexamfetamine Dimesylate
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors