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. 2023 Jan 20:32:101066.
doi: 10.1016/j.conctc.2023.101066. eCollection 2023 Apr.

Protocol for a pilot and feasibility randomized-controlled trial of four weeks of oral γ-aminobutyric acid (GABA) intake and its effect on pain and sleep in middle-to-older aged adults

Soamy Montesino-Goicolea  1   2   3 , Olga Nin  4 , Barbara M Gonzalez  1   2 , Nathalie J Sawczuk  1   2 , Chavier Laffitte Nodarse  1   2 , Pedro Antonio Valdes-Hernandez  1   2 , Elijah Jackson  1   2 , Zhiguang Huo  5 , Jessie Elise T Somerville  1   2 , Eric C Porges  6   7 , Cameron Smith  4 , Roger B Fillingim  1   2   3 , Yenisel Cruz-Almeida  1   6   2   3
Affiliations

Protocol for a pilot and feasibility randomized-controlled trial of four weeks of oral γ-aminobutyric acid (GABA) intake and its effect on pain and sleep in middle-to-older aged adults

Soamy Montesino-Goicolea et al. Contemp Clin Trials Commun. .

Abstract

Approximately 1.71 billion people globally live with musculoskeletal pain conditions, including low back pain, knee pain, and neck pain Cieza et al. (2020). In the US, an estimated 20.4% of U.S. adult had chronic pain and 8.0% of U.S. adults had high-impact chronic pain, with higher prevalence associated with advancing age Dahlhamer et al. (2018). On the other hand, between 50 and 70 million US adults have a sleep disorder (American Sleep Association). Although the link between sleep and pain is widely established, the neurobiological mechanisms underlying this relationship have yet to be fully elucidated, specifically within an aged population. As currently available sleep and chronic pain therapies are only partially effective, novel treatment approaches are urgently needed. Given the potential mechanistic role of γ-aminobutyric acid (GABA) in both conditions, and the availability of GABA supplements over the counter, the present proposal will determine the feasibility and acceptability of oral GABA administration in middle-to-older aged adults with chronic pain and sleep disorders as well as characterize the potential neurobiological mechanisms involved in both conditions. Results from the present investigation using a parallel, double-blinded, placebo-controlled study will provide novel preliminary information needed for future translational pain and sleep research.

Keywords: Chronic pain; Clinical trial; GABA; Pilot study; Sleep.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Mechanistic working model.
Fig. 2
Fig. 2
Study procedures.
See this image and copyright information in PMC

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