RECRUITING

Effects of 5HTP on the Injured Human Spinal Cord

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-07-01
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04520178

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * participants must have suffered trauma to the spinal cord at least six months ago or longer
  1. * individuals with damage to the nervous system other than to the spinal cord
  2. * pregnant and/or breastfeeding women
  3. * alcoholic participants
  4. * history of seizure/epilepsy
  5. * history of suicidal thoughts or behaviors
  6. * known or suspected allergy to the medication ingredients
  7. * cardiovascular disease including history of heart attack or heart rhythm irregularities
  8. * coronary artery disease
  9. * reduced liver function or disease
  10. * reduced kidney function or disease
  11. * lung disease
  12. * comatose or depressed states due to CNS depressants
  13. * endocrine dysfunction
  14. * blood dyscrasias or blood related disease
  15. * bone marrow depression
  16. * hypocalcemia
  17. * history of stomach ulcers
  18. * wide angle glaucoma
  19. * phenylketonuria
  20. * history of tumors
  21. * uncontrolled heart problems
  22. * unstable psychiatric or mental disorder
  23. * monoamine oxidase inhibitor therapy
  24. * serotonergic antidepressants
  25. * tricyclic antidepressants
  26. * any type of serotonergic agonist
  27. * dopamine D2 receptor antagonists
  28. * amphetamine
  29. * CNS depressants
  30. * levodopa
  31. * lithium
  32. * anti-hypertensive drugs
  33. * iron salts
  34. * metoclopramide
  35. * phenothiazine medication

Contacts and Locations

Study Contact

Jessica D'Amico, PhD
CONTACT
780-735-7917
damico1@ualberta.ca

Principal Investigator

Jessica D'Amico, PhD
PRINCIPAL_INVESTIGATOR
University of Alberta

Study Locations (Sites)

University of Louisville
Louisville, Kentucky, 40292
United States

Collaborators and Investigators

Sponsor: University of Alberta

  • Jessica D'Amico, PhD, PRINCIPAL_INVESTIGATOR, University of Alberta

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-01
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2020-07-01
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries