Effects of 5HTP on the Injured Human Spinal Cord

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Treatments: 5-Hydroxytryptophan; Carbidopa

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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