Phase
Condition
Chronic Pain
Pain
Treatment
Placebo
GABA
Clinical Study ID
Ages 45-100 All Genders
Study Summary
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:
serious psychiatric conditions (e.g., schizophrenia, major depression, bipolardisorder;
history of alcohol/drug abuse;
Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology andneurological conditions;
significant cognitive impairment as evidenced by the Modified Mini-Mental StateExamination [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), (uncontrolledhypertension > 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 anyserious 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) andeszopiclone (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 itsingredients: 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 andclaustrophobia;
current cancer diagnosis unless determined no evidence of disease or in remissionfor at least two years, and
pregnancy
Study Design
Connect with a study center
University of Florida
Gainesville, Florida 32610
United StatesSite Not Available
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