๐ฌIn plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to learn if a personalized, brain-scan-guided form of transcranial magnetic stimulation (TMS) works better than a standard TMS approach at changing reward-related brain activity in adults who smoke cigarettes. The main questions it aims to answer are:
Does personalized TMS produce a greater change in reward-related brain activity than the standard approach? Does personalized TMS lead to a greater reduction in cravings and cigarette smoking than the standard approach?
Researchers will compare personalized TMS, which targets a treatment location chosen from each participant's own brain scan, to a standard TMS approach, which targets a location based on anatomical landmarks, to see if the personalized approach produces stronger effects on brain reward activity and smoking behavior.
Participants will:
Complete an magnetic resonance imaging (MRI) brain s
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Be between the ages of 18 and 60 years old
* Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level greater than 10 ppm indicative of recent smoking
* Have not received substance abuse treatment within the previous 30 days
* Meet criteria for Tobacco Use Disorder as determined by the Mini International Neuropsychiatric Interview (MINI): meeting 4 or more of the 11 diagnostic symptoms of Tobacco Use Disorder within a 12-month period
* If female, test non-pregnant
* Show no evidence of focal or diffuse brain lesions on MRI
* Be willing to provide informed consent
* Be able to comply with protocol requirements and likely to complete all study procedures
* Be motivated to quit smoking, based on a response of "very likely" or "somewhat likely" on the Motivation to Stop Scale (scores 4-7)
Exclusion Criteria:
* Meeting MINI diagnostic criteria for any non-tobacco substance use disorder other than Caffeine Use Disorder, Cannabis Use Disorder - Mild, or Alcohol Use Disorder - Mild (Mild defined as meeting 2 to 3 of the 11 diagnostic symptoms within a 12-month period)
* Contraindications to MRI (e.g., metal in the skull, orbital, or intracranial cavity, or claustrophobia)
* Contraindication to repetitive TMS
* History of autoimmune, endocrine, viral, or vascular disorders affecting the brain
* History or MRI evidence of a neurological disorder causing local or diffuse brain lesions or significant physical impairment
* Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea
* Lifetime history of major Axis I disorders as confirmed by the MINI, including bipolar affective disorder, schizophrenia, post-traumatic stress disorder, suicidal ideation, or major depression
* Current use of tobacco cessation pharmacotherapies, including nicotine patches, electronic cigarettes, gum, nasal spray, inhalers, nicotine lozenges, varenicline, or bupropion
* Previous treatment with TMS