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New treatment option for Tobacco Use
Official title RTMS Targets Neural Circuits for Smoking Cessation
ClinicalTrials.gov ID: NCT04903028
What this study is testing
- What it's testing
- Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers.
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Be between the ages of 22 and 70 years old.
- Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level \> 10 ppm indicative of recent smoking.
- Have not received substance abuse treatment within the previous 30 days.
- Meet the criteria for tobacco use disorder as determined by DSM-5.
- Be in stable mental and physical health.
You likely can't join if
- Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria.
- Contraindications to MRI (e.g., presence of metal in the skull, orbital or intracranial cavity, or having claustrophobia).
- Contraindication to rTMS.
- History of autoimmune, endocrine, viral, or vascular disorders affecting the brain.
- History or MRI evidence of neurological disorder that would lead to 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 22 and 70 years old.
- Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level \> 10 ppm indicative of recent smoking.
- Have not received substance abuse treatment within the previous 30 days.
- Meet the criteria for tobacco use disorder as determined by DSM-5.
- Be in stable mental and physical health.
- If female, test non-pregnant and use adequate birth control.
- 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 responses of "very likely," or "somewhat likely" in the motivation questionnaire).
- Current moderate to severe substance use of any psychoactive substances other than nicotine or caffeine, as defined by DSM-V criteria.
- Contraindications to MRI (e.g., presence of metal in the skull, orbital or intracranial cavity, or having claustrophobia).
- Contraindication to rTMS.
- History of autoimmune, endocrine, viral, or vascular disorders affecting the brain.
- History or MRI evidence of neurological disorder that would lead to 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 such as: bipolar affective disorder (BPAD), schizophrenia, post-traumatic stress disorder (PTSD), dementia, suicidal ideation or major depression.
- Self-report of \>21 standard alcohol drinks per week in any week in the 30 days prior to screening.
- Use of other forms of nicotine delivery, such as nicotine patches, electronic cigarettes, gum, nasal spray, inhalers, and nicotine lozenges.
- Use of other tobacco products, including cigars, cigarillos, chew, snuff, and pouches/snus.
- Previous treatment with TMS.
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 4 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, 22 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.