Tobacco Use Disorder study: PRIME TMS vs Standard TMS
Official title Modulating Neural Mechanisms of Reward Processing in Tobacco Users
ClinicalTrials.gov ID: NCT07812753
What this study is testing
- What it's testing
- The study compares personalized TMS, guided by each person’s brain scan, to standard TMS to see which changes reward‑related brain activity more and reduces cravings and smoking.
- Who it's for
- Adults who smoke cigarettes and have tobacco use disorder.
- What's involved
- Participants get an MRI scan, fill out smoking and mood questionnaires, and then receive 15 TMS sessions over 3 weeks. Each session includes EEG recordings and craving check‑ins before and after. Follow‑up visits occur 1 week and 1 month after treatment.
- Time commitment
- The study lasts about 3 weeks of daily TMS sessions plus two follow‑up visits, for a total of roughly 5 weeks.
- Time commitment: about 3 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- If female, test non-pregnant
You likely can't join if
- Meeting MINI diagnostic criteria for any non-tobacco substance use disorder other than Caffeine Use Disorder, Cannabis Use Disorder - Mild, or...
- 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
See the full eligibility 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)
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Newark, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Newark, New Jersey, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.