Latent Aging Mechanisms in Pain and Sleep

Study Overview
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Brief Summary
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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.

Official Title
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Sleep, Pain and Aging: Potential Underlying Mechanisms

Conditions
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Chronic Pain

Intervention / Treatment
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* Dietary Supplement: GABA
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily Oral GABA<br>You will take, by mouth, 2 pills of GABA (500 mg) (Capsule 250mg) daily at home for 4 weeks | Dietary Supplement: GABA<br>* Daily oral GABA for 4 weeks<br>* Other names: Gamma aminobutyric acid;|
| Placebo Comparator: Daily Placebo<br>You will take, by mouth, 2 pills of Placebo daily at home for 4 weeks | Drug: Placebo<br>* Daily oral Placebo for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Reported Sleep Quality Scoring | Self-Reported Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) and PSQI total score will be the primary sleep outcome measure to compare to sleep quality using objective and self-reported measures. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. | Baseline up to 1 month |