Latent Aging Mechanisms in Pain and Sleep

Last updated: June 30, 2025
Sponsor: University of Florida
Overall Status: Completed

Phase

2

Condition

Chronic Pain

Pain

Treatment

Placebo

GABA

Clinical Study ID

NCT04683640
IRB202000105-N
P30AG059297
  • Ages 45-100
  • All Genders

Study Summary

Chronic pain is a serious public health problem in older adults depending on the pain condition, and the capacity to sleep properly changes with age. Given the potential mechanistic role of GABA (gamma-aminobutyric acid) in both conditions, based on our preliminary data, this proposal will determine the effect of oral GABA administration in sleep quality and pain in older adults with chronic pain and sleep disorders as well as to characterize the potential neurobiological mechanisms involved in both illnesses.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Older adults 45 years of age or older who experienced pain of at least moderateintensity (>5/10 pain intensity ratings) on more days than not during the past threemonths, and who also reported poor sleep quality (>5 PSQI scores) will be consideredfor participation.

Exclusion

Exclusion Criteria:

  1. serious psychiatric conditions (e.g., schizophrenia, major depression, bipolardisorder;

  2. history of alcohol/drug abuse;

  3. Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology andneurological conditions;

  4. significant cognitive impairment as evidenced by the Modified Mini-Mental StateExamination [3MS] score ≤ 77;

  5. hospitalizations for mental health reasons in the past year;

  6. chronic/current use of narcotic medications;

  7. serious systemic (uncontrolled diabetes self-reported HA1C>7), (uncontrolledhypertension > 155/90 mm Hg) and rheumatic disorders (i.e., rheumatoid arthritis,systemic lupus erythematosus, fibromyalgia, HIV);

  8. arterial hypotension;

  9. digestive tract diseases;

  10. major medical surgery in the past two months, history of brain surgery or anyserious brain condition like aneurysm, stroke, or seizures;

  11. excessive anxiety regarding protocol procedures;

  12. Inability to consent for study participation;

  13. Ingestion of sleep medications including those with zolpidem (Ambien and others) andeszopiclone (Lunesta and others);

  14. Neuropathic pain medications including anticonvulsants and antidepressants;

  15. Allergies or sensitivity to GABA or its ingredients cellulose' gelatin (capsule)'magnesium silicate' vegetable stearate and silica or to the placebo or itsingredients: calcium laurate, hypromellose capsule, magnesium (citrate),microcrystalline cellulose;

  16. currently taking barbiturate and benzodiazepine and baclofen;

  17. MRI contraindications including large pieces of metal in the body/face/neck andclaustrophobia;

  18. current cancer diagnosis unless determined no evidence of disease or in remissionfor at least two years, and

  19. pregnancy

Study Design

Total Participants: 33
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 02, 2021
Estimated Completion Date:
May 30, 2024

Connect with a study center

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

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