Latent Aging Mechanisms in Pain and Sleep

NCT ID: NCT04683640

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-02
• Study Completion Date: 2024-05-30

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Daily Oral GABA

You will take, by mouth, 2 pills of GABA (500 mg) (Capsule 250mg) daily at home for 4 weeks

Group Type: EXPERIMENTAL

GABA

Intervention Type: DIETARY_SUPPLEMENT

Daily oral GABA for 4 weeks

Daily Placebo

You will take, by mouth, 2 pills of Placebo daily at home for 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Daily oral Placebo for 4 weeks

Interventions

GABA

Daily oral GABA for 4 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Daily oral Placebo for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Gamma aminobutyric acid

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Thorne HealthTech, Inc

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yenisel Cruz-Almeida, MSPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30AG059297

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB202000105-N

Identifier Type: -

Identifier Source: org_study_id