Clinical trial NCT04683640: Latent Aging Mechanisms in Pain and Sleep
Official title: Sleep, Pain and Aging: Potential Underlying Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Thorne HealthTech, Inc
First posted: 2020-12-24
Enrollment: 28
Sex: ALL
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 (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 Criteria:

* 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 Criteria:

1. serious psychiatric conditions (e.g., schizophrenia, major depression, bipolar disorder;
2. history of alcohol/drug abuse;
3. Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology and neurological conditions;
4. significant cognitive impairment as evidenced by the Modified Mini-Mental State Examination \[3MS\] 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), (uncontrolled hypertension \> 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 any serious 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) and eszopiclone (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 its ingredients: 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 and claustrophobia;
18. current cancer diagnosis unless determined no evidence of disease or in remission for at least two years, and
19. pregnancy

Primary outcomes:
measure: Self-Reported Sleep Quality Scoring
timeFrame: Baseline up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Yenisel Cruz-Almeida, MSPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: