Status:
COMPLETED
Latent Aging Mechanisms in Pain and Sleep
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute on Aging (NIA)
Thorne HealthTech, Inc
Conditions:
Chronic Pain
Eligibility:
All Genders
45-100 years
Phase:
PHASE2
Brief 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 (gamm...
Eligibility Criteria
Inclusion
- Older adults 45 years of age or older who experienced pain of at least moderate intensity (\>5/10 pain intensity ratings) on more days than not during the past three months, and who also reported poor sleep quality (\>5 PSQI scores) will be considered for participation.
Exclusion
- serious psychiatric conditions (e.g., schizophrenia, major depression, bipolar disorder;
- history of alcohol/drug abuse;
- Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology and neurological conditions;
- significant cognitive impairment as evidenced by the Modified Mini-Mental State Examination \[3MS\] score ≤ 77;
- hospitalizations for mental health reasons in the past year;
- chronic/current use of narcotic medications;
- serious systemic (uncontrolled diabetes self-reported HA1C\>7), (uncontrolled hypertension \> 155/90 mm Hg) and rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia, HIV);
- arterial hypotension;
- digestive tract diseases;
- major medical surgery in the past two months, history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures;
- excessive anxiety regarding protocol procedures;
- Inability to consent for study participation;
- Ingestion of sleep medications including those with zolpidem (Ambien and others) and eszopiclone (Lunesta and others);
- Neuropathic pain medications including anticonvulsants and antidepressants;
- Allergies or sensitivity to GABA or its ingredients cellulose' gelatin (capsule)' magnesium silicate' vegetable stearate and silica or to the placebo or its ingredients: calcium laurate, hypromellose capsule, magnesium (citrate), microcrystalline cellulose;
- currently taking barbiturate and benzodiazepine and baclofen;
- MRI contraindications including large pieces of metal in the body/face/neck and claustrophobia;
- current cancer diagnosis unless determined no evidence of disease or in remission for at least two years, and
- pregnancy
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04683640
Start Date
April 2 2021
End Date
May 30 2024
Last Update
July 18 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610