Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
10 participants
INTERVENTIONAL
2022-09-12
2023-12-19
Brief Summary
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Detailed Description
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One major obstacle in understanding how neuroinflammation influences motivation involves technological challenges such that conventional approaches are invasive, expensive, and/or lacking specificity. Although static levels of neuroinflammation in humans have been measured via cross sectional studies, capturing behavioral shifts following experimental manipulation has not been done. This gap limits the ability to develop a more precise understanding of how neuroinflammation causes motivational deficits in humans. The proposed project will employ a mechanistic clinical trial of the anti-\[neuro\]inflammatory agent, minocycline, to address these limitations. In animal models, minocycline has attenuated the deleterious effects of neuroinflammation on neurogenesis, long-term potentiation, and neuronal survival. This study will extend research to humans to examine whether links between neuroinflammation and behavioral responses to a reward-related motivation task differ among chronically stressed individuals taking minocycline and the placebo control. The proposed project will provide preliminary evidence for potential neural targets that have relevance for motivational deficits due to neuroinflammation.
Once screening is complete, participants will come to UNC to complete quality-of-life surveys, learn about the full study schedule, and receive the first dose of medication. This visit will last about 90 minutes. Participants will be asked to participate in two medication periods, meaning they will take both minocycline (antibiotic medication) for 5-days, and an inactive substance (placebo sugar pill) for 5-days. This will investigate whether there are changes in their responses to negative and positive information. After taking the first medication for five days, participants will come in to complete a computer task (Probabilistic Reward Task) and some follow-up surveys (Snaith-Hamilton Pleasure Scale and Motivation and Pleasure Scale). This visit will last about 90 minutes. Participants will then get at least a 2-week break before taking the second medication for five days. Then, they will come back for another 90-minute visit to complete the same computer task and follow-up surveys. The total study duration including the break is about one month. The total time in study sessions on campus over the month will be 4.5 hours.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo followed by Minocycline
In this arm, participants will take a 5-day course of placebo-control pills and then a 5-day course of 200 mg of minocycline. Sessions will be separated by a minimum washout period of 14 days.
Minocycline
Participants will take 2 pills of 100 mg totaling a 200 mg dose of minocycline per day.
Placebo
A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 2 placebo tablets matching the Minocycline tablets daily for 5 days.
Minocycline followed by Placebo
In this arm, participants will take a 5-day course of 200 mg of minocycline and then a 5-day course of placebo-control pills. Sessions will be separated by a minimum washout period of 14 days.
Minocycline
Participants will take 2 pills of 100 mg totaling a 200 mg dose of minocycline per day.
Placebo
A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 2 placebo tablets matching the Minocycline tablets daily for 5 days.
Interventions
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Minocycline
Participants will take 2 pills of 100 mg totaling a 200 mg dose of minocycline per day.
Placebo
A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 2 placebo tablets matching the Minocycline tablets daily for 5 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unemployed (working less than 20 hours per week)
* Have been unemployed for at least 6 months
* Seeking employment
* Having trouble finding a job (i.e., actively seeking and applying for jobs but not successful in landing a job)
* Reports greater than 5 points on Job Stress Items
* Regular access to a mobile phone
Exclusion Criteria
* neurological conditions (e.g., Traumatic Brain Injury, stroke)
* pregnant (as measured by urine pregnancy screen) or breastfeeding
* current use of psychotropic medications
* Current regular recreational drug or alcohol use (i.e., 4 or more times per week)
* chronic diseases that significantly impact inflammatory markers (e.g., cancer)
* known allergies or hypersensitivities to tetracycline antibiotics, aspirin or other NSAIDs
* current antibiotic use
* regular use of steroidal or non-steroidal anti-inflammatory medications (i.e., 2 or more times a week)
25 Years
60 Years
ALL
Yes
Sponsors
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Robert Wood Johnson Foundation
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Gabriella Alvarez, PhD
Role: STUDY_DIRECTOR
University of North Carolina, Chapel Hill
Keely Muscatell, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Howell Hall
Chapel Hill, North Carolina, United States
Countries
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References
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Kangas BD, Der-Avakian A, Pizzagalli DA. Probabilistic Reinforcement Learning and Anhedonia. Curr Top Behav Neurosci. 2022;58:355-377. doi: 10.1007/7854_2022_349.
Snaith RP, Hamilton M, Morley S, Humayan A, Hargreaves D, Trigwell P. A scale for the assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. Br J Psychiatry. 1995 Jul;167(1):99-103. doi: 10.1192/bjp.167.1.99.
Llerena K, Park SG, McCarthy JM, Couture SM, Bennett ME, Blanchard JJ. The Motivation and Pleasure Scale-Self-Report (MAP-SR): reliability and validity of a self-report measure of negative symptoms. Compr Psychiatry. 2013 Jul;54(5):568-74. doi: 10.1016/j.comppsych.2012.12.001. Epub 2013 Jan 22.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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21-3111
Identifier Type: -
Identifier Source: org_study_id