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New treatment option for Nicotine Dependence
Official title Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)
ClinicalTrials.gov ID: NCT07145866
What this study is testing
What is Varenicline?
Varenicline is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for nicotine dependence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if a combination of varenicline and enhanced accelerated Transcranial Magnetic Stimulation (aTMS) works to help adults quit using nicotine products. Researchers will compare varenicline + active aTMS with a single dose of D-Clycloserine to varenicline + sham (inactive) aTMS with a placebo pill to see the effect of enhanced aTMS on reaching abstinence.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 65
You may be able to join if
- Age ≥ 18 and ≤65;
- The ability to give written, informed consent;
- Fluency in English;
- Reported interest in quitting nicotine vaping or smoking within the next month;
- Nicotine dependence, as defined by a score of ≥4 on the 10-question E-cigarette Dependence Inventory (ECDI) or Fagerström Test for Nicotine...
You likely can't join if
- Pregnancy or breastfeeding;
- Use of smoking cessation pharmacotherapy in the past month;
- Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study;
- Prior adverse drug reaction to varenicline;
- Contraindication to D-Cycloserine (including allergy to D-Cycloserine, significant renal impairment or known kidney disease, pregnancy)
- Receiving or planning to receive other TMS treatments or investigational drugs during course of participation
See the full eligibility criteria
- Age ≥ 18 and ≤65;
- The ability to give written, informed consent;
- Fluency in English;
- Reported interest in quitting nicotine vaping or smoking within the next month;
- Nicotine dependence, as defined by a score of ≥4 on the 10-question E-cigarette Dependence Inventory (ECDI) or Fagerström Test for Nicotine Dependence (FTND);
- Smoke or vape nicotine daily for at least the past 90 days, as confirmed by self-report and timeline follow-back methods;
- Saliva cotinine \>30ng/mL;
- Pregnancy or breastfeeding;
- Use of smoking cessation pharmacotherapy in the past month;
- Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study;
- Prior adverse drug reaction to varenicline;
- Contraindication to D-Cycloserine (including allergy to D-Cycloserine, significant renal impairment or known kidney disease, pregnancy)
- Receiving or planning to receive other TMS treatments or investigational drugs during course of participation
- Contraindications to TMS (including seizures, metallic implants, severe existing tinnitus, etc.);
- Contraindications to MRI (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia);
- Inpatient psychiatric hospitalization or suicide attempts in the past six months, or recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits;
- History of seizures and/or history of TBI subtypes associated with elevated seizure risk (e.g. penetrating injury and intraparenchymal hemorrhage)
- History of unstable neurological illness or major medical illness, such as epilepsy or renal impairment, in the past six months, unless clearly resolved;
- In the opinion of the investigators, evidence of active problem substance use severe enough to compromise ability to safely participate;
- In the opinion of the investigators, unable to safely participate in this study and/or provide reliable data (e.g., claustrophobia, unable to tolerate TMS or MRI procedures, etc.).
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, 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.