National Institutes of Health Toolbox Emotion Battery for English- and Spanish-speaking adults: normative data and factor-based summary scores.
Ida Babakhanyan, Benjamin S McKenna, Kaitlin B Casaletto...
https://pubmed.ncbi.nlm.nih.gov/29588623/Actively Recruiting
Led by The University of Texas at Dallas · Updated on 2026-06-26
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are studying how temporarily stopping and then restarting tirzepatide, a medication used to regulate blood sugar and appetite, impacts brain activity, behavior, and health in adults aged 18 to 70 who are currently taking the drug. The study focuses on effects such as changes in hunger, mood, sleep, and daily function. It aims to understand brain chemistry and brain responses to food images during these medication changes and how these relate to quality of life and emotional well-being. Participants will pause tirzepatide for 3 to 4 weeks and then restart it for 6 to 8 weeks, all under a study physicians supervision. The study includes three in-person visits during which participants undergo brain scans using MRI and MR spectroscopy, provide stool and urine samples, complete interviews, questionnaires, and cognitive tasks. Between visits, participants will complete two brief phone check-ins and an online BrainHealth Index assessment. Throughout the approximately 13-week study, researchers will monitor changes in brain responses to food cues, brain connectivity, brain glutamate levels, cravings, mood, stress, sleep quality, eating behaviors, and cognitive function. Safety and comfort are maintained by medical supervision during medication changes. The study collects detailed behavioral and biological data to better understand the effects of tirzepatide discontinuation and reinitiation.
CONDITIONS
Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation
S
Samuel H Poelker-Wells, Master of Science
A
Aishwarya Veerkumar, Master of Public Health
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The University of Texas at Dallas
Lead Sponsor
University of Texas Southwestern Medical Center
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Intervention in this trial | Usual clinical care |
|---|---|---|
| What it is | A study protocol in which participants temporarily stop tirzepatide for 3–4 weeks then restart it for another 6–8 weeks under physician supervision | Ongoing use of daily or weekly tirzepatide without interruption as part of routine weight management practice |
| Role in the study | Investigational sequence being tested to assess neurobehavioral and brain changes with temporary treatment pause and restart | Not part of trial design; represents typical clinical practice for uninterrupted tirzepatide therapy |
| Primary purpose | To observe effects on brain activity, mood, appetite, and behavior during stop‑restart of tirzepatide | To support ongoing weight reduction and metabolic management in obesity as per current clinical guidelines |
| How administered or followed | Prescription is paused for 3–4 weeks then resumed for 6–8 weeks under physician oversight, with MRI, behavioral assessments, stool sampling and questionnaires during three in‑person visits | Weekly injection of tirzepatide continued without interruption alongside routine monitoring and follow‑up |
| Evidence status | Evidence limited to this early‑phase study; trial will generate new data on neurobehavioral changes | Supported by multiple clinical guidelines for effective weight reduction in obesity management |
| Important risks | Unknown risks related to temporary cessation and reinitiation, including possible metabolic or cardiovascular fluctuations | Known adverse effects include gastrointestinal events and discontinuation may lead to weight regain and loss of metabolic benefits |
| Important limitations | Small early‑phase study with limited generalizability; effects may not extend to broader populations | Guideline recommendations based on larger obesity trials, but long‑term adherence in real‑world may be limited |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 13 weeks total
Participants attend three visits while taking tirzepatide, during a 3-4 week pause, and after restarting for 6-8 weeks. Each visit includes brain scans, interviews, questionnaires, cognitive tasks, and stool sample collection. Between visits, participants complete phone check-ins and online assessments. All medication changes are supervised by a study physician.
Three visits lasting about 3-4 hours each, plus two phone check-ins and online assessments
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/30597585/The University of Texas at Dallas
Lead Sponsor
University of Texas Southwestern Medical Center
Collaborating Sponsor