CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04683640
NCT04683640Phase 2Completed
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Sleep, Pain and Aging: Potential Underlying Mechanisms

University of Florida·interventional·Posted Dec 24, 2020·Updated Jul 18, 2025

In Brief

A Phase 2 clinical trial evaluating GABA and Placebo for Chronic Pain. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA), Thorne HealthTech, Inc

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 24, 2020
Enrollment StartApr 2, 2021
Primary CompletionMay 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.5 years ago

Interventions

GABAdietary

Daily oral GABA for 4 weeks

Placebodrug

Daily oral Placebo for 4 weeks