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Latent Aging Mechanisms in Pain and Sleep (LAMPS)

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GABA
Placebo
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Pain

Eligibility Criteria

45 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Older adults over 65 years of age 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:

  • Serious psychiatric conditions (e.g., schizophrenia, major depression, bipolar disorder
  • History of alcohol/drug abuse
  • Alzheimer, Parkinson, Epilepsy and other known intracerebral pathology and neurological conditions
  • 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
  • Chronic/current use of narcotic medications
  • Serious systemic (uncontrolled diabetes self-reported HA1C>7) and rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia, HIV)
  • arterial hypotension
  • Digestive tract diseases
  • Major medical surgery in the past two months
  • History of brain surgery or any serious brain condition like aneurysm, stroke, or seizures;
  • Excessive anxiety regarding protocol procedures;
  • Inability to consent for study participation
  • Ingestion of sleep medications including those with zolpidem (Ambien and others) and eszopiclone (Lunesta and others)
  • Neuropathic pain
  • Medications including anticonvulsants and antidepressants
  • Hypertension medications
  • 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
  • Currently taking barbiturate and benzodiazepine and baclofen
  • MRI contraindications including large pieces of metal in the body/face/neck and claustrophobia
  • Current cancer diagnosis unless determined no evidence of disease or in remission for at least two years

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Daily Oral GABA

Daily Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Self-Reported Sleep Quality Scoring
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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2020
Last Updated
June 12, 2023
Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA), Thorne HealthTech, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04683640
Brief Title
Latent Aging Mechanisms in Pain and Sleep
Acronym
LAMPS
Official Title
Sleep, Pain and Aging: Potential Underlying Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA), Thorne HealthTech, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
254 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Daily Oral GABA
Arm Type
Experimental
Arm Description
You will take, by mouth, 2 pills of GABA (500 mg) (Capsule 250mg) daily at home for 4 weeks
Arm Title
Daily Placebo
Arm Type
Placebo Comparator
Arm Description
You will take, by mouth, 2 pills of Placebo daily at home for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
GABA
Other Intervention Name(s)
Gamma aminobutyric acid
Intervention Description
Daily oral GABA for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily oral Placebo for 4 weeks
Primary Outcome Measure Information:
Title
Self-Reported Sleep Quality Scoring
Description
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.
Time Frame
Baseline up to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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: serious psychiatric conditions (e.g., schizophrenia, major depression, bipolar disorder; history of alcohol/drug abuse; Alzheimer, Parkinson, Epilepsy and other known intra-cerebral pathology and neurological conditions; significant cognitive impairment as evidenced by the Modified Mini-Mental State Examination [3MS] score ≤ 77; hospitalizations for mental health reasons in the past year; chronic/current use of narcotic medications; 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); arterial hypotension; digestive tract diseases; major medical surgery in the past two months, history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures; excessive anxiety regarding protocol procedures; Inability to consent for study participation; Ingestion of sleep medications including those with zolpidem (Ambien and others) and eszopiclone (Lunesta and others); Neuropathic pain medications including anticonvulsants and antidepressants; 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; currently taking barbiturate and benzodiazepine and baclofen; MRI contraindications including large pieces of metal in the body/face/neck and claustrophobia; current cancer diagnosis unless determined no evidence of disease or in remission for at least two years, and pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessie Somerville, BS
Phone
352-294-8304
Email
jsomerville@dental.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Soamy Montesino-Goicolea, MD
Phone
352-273-5971
Email
smontesinogoicolea@dental.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yenisel Cruz-Almeida, MSPH, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessie Somerville
Phone
352-294-8304
Email
jsomerville@dental.ufl.edu
First Name & Middle Initial & Last Name & Degree
Soamy Montesino-Goicolea, MD
Phone
352-273-5971
Email
smontesinogoicolea@dental.ufl.edu
First Name & Middle Initial & Last Name & Degree
Yenisel Cruz-Almeida

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Latent Aging Mechanisms in Pain and Sleep

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