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Latent Aging Mechanisms in Pain and Sleep

NCT04683640 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-07-18

Study results available
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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

Interventions

DIETARY_SUPPLEMENT

GABA

Daily oral GABA for 4 weeks

DRUG

Placebo

Daily oral Placebo for 4 weeks

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Thorne HealthTech, Inc

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Yenisel Cruz-Almeida, MSPH, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-02
Primary Completion
2024-05-30
Completion
2024-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04683640 on ClinicalTrials.gov