RecruitingPhase 2Phase 3NCT04520178

Effects of 5HTP on the Injured Human Spinal Cord

Effects of the Serotonin Precursor, 5-hydroxytryptophan, in the Injured Human Spinal Cord


Sponsor

University of Alberta

Enrollment

30 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This study will assess how the serotonin precursor, 5-HTP, alter nervous system excitability and motor function in individuals with spinal cord injuries of differing chronicity and severity. Participants will visit the lab on 4 separate occasions where they will be administered four different drugs in a randomized, double-blinded, placebo-controlled crossover design.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

  • participants must have suffered trauma to the spinal cord at least six months ago or longer

Exclusion Criteria36

  • individuals with damage to the nervous system other than to the spinal cord
  • pregnant and/or breastfeeding women
  • alcoholic participants
  • history of seizure/epilepsy
  • history of suicidal thoughts or behaviors
  • known or suspected allergy to the medication ingredients
  • cardiovascular disease including history of heart attack or heart rhythm irregularities
  • coronary artery disease
  • reduced liver function or disease
  • reduced kidney function or disease
  • lung disease
  • comatose or depressed states due to CNS depressants
  • endocrine dysfunction
  • blood dyscrasias or blood related disease
  • bone marrow depression
  • hypocalcemia
  • history of stomach ulcers
  • wide angle glaucoma
  • phenylketonuria
  • history of tumors
  • uncontrolled heart problems
  • unstable psychiatric or mental disorder
  • Participants taking:
  • monoamine oxidase inhibitor therapy
  • serotonergic antidepressants
  • tricyclic antidepressants
  • any type of serotonergic agonist
  • dopamine D2 receptor antagonists
  • amphetamine
  • CNS depressants
  • levodopa
  • lithium
  • anti-hypertensive drugs
  • iron salts
  • metoclopramide
  • phenothiazine medication

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Interventions

DRUG5-Hydroxytryptophan 100 MG

100mg combined with 50mg carbidopa

DRUG5-Hydroxytryptophan

50mg combined with 50mg carbidopa

DRUGCarbidopa

50mg

DRUGPlacebo

Placebo


Locations(2)

University of Louisville

Louisville, Kentucky, United States

University of Alberta

Edmonton, Alberta, Canada

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NCT04520178


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