Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: addiction
- Who it enrolls
- age 18 Years to 70 Years; excludes diabetes; no BMI minimum stated; conditions: Drug Discontinuation; Substance Use Disorders; Eating Behavior Changes; Tirzepatide
- Interventions
- Discontinuation and Reinitiation of Tirzepatide
- Conditions
- Drug Discontinuation; Substance Use Disorders; Eating Behavior Changes; Tirzepatide
- Phase and size
- NA · 40 participants
- Dates
- Start 2026-10
Primary completion 2028-02 - Sponsor
- The University of Texas at Dallas (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change From On-Treatment to Discontinuation and Re-Initiation in Food Cue-Evoked BOLD Response in Reward and Salience Brain RegionsBaseline (on tirzepatide), 3-4 weeks of discontinuation, and 6-8 weeks of re-initiation
02Eligibility
Who can take part
Inclusion Criteria: * Aged 18-70 years. * Currently on tirzepatide. * Currently receiving care from University of Texas- Southwestern (UTSW) Weight Wellness Clinic. * Cognitively capable of understanding and signing informed consent. * Be proficient in English. Exclusion Criteria: * History of major neurological or psychiatric disorders, including substance use disorders that might confound brain imaging results (e.g., stroke, epilepsy, multiple sclerosis, schizophrenia, major depression requiring hospitalization). * Diagnosis of Type 2 Diabetes. * Current diagnosis of an eating disorder. * Use of medications affecting weight other than tirzepatide. * Pregnancy or breastfeeding. * MR contraindications: * Heart pacemaker, heart valve replacement, or aortic clips * Metal fragments in the eyes, skin, or elsewhere in the body * Brain clips or pieces of metal used in aneurysm surgery or intercranial bypass * Venous umbrella * Pieces of metal in the body resulting from work as a sheet-metal worker or welder * Clips placed in an internal organ * Prosthetic devices, such as middle ear, eye, joint, or penile implants * Joint replacement * Hearing aid that cannot be removed * Neurostimulator * Insulin pump * Shunts or stents * Metal mesh or coil implants * Metal plate, pin, screws, or wires, or any other metal implants
03Change log
Registry changes
No changes recorded since the trial was added.