Latent Aging Mechanisms in Pain and Sleep

Phase 2

Completed

• Conditions: Chronic Pain
• Interventions: Dietary Supplement: GABA; Drug: Placebo

• Registration Number: NCT04683640
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-21
• Study First Posted: 2020-12-24
• Study Start: 2021-04-02
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily Oral GABA	GABA	You will take, by mouth, 2 pills of GABA (500 mg) (Capsule 250mg) daily at home for 4 weeks
Daily Placebo	Placebo	You will take, by mouth, 2 pills of Placebo daily at home for 4 weeks

Primary Outcome Measures

Name	Time	Method
Self-Reported Sleep Quality Scoring	Baseline up to 1 month	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States