Nicotine Dependence study: Varenicline vs D-cycloserine
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?
An investigational medication being studied as a potential treatment for nicotine dependence. It is designed to bind to nicotine receptors in the brain and reduce cravings and withdrawal symptoms.
Also referred to as Chantix.
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 study wants to find out whether adding accelerated transcranial magnetic stimulation (aTMS) to varenicline improves quitting rates and reduces cravings compared to varenicline alone.
- Who it's for
- Adults who currently use nicotine products and want to quit.
- What's involved
- Participants will take varenicline daily for 12 weeks, receive up to 20 aTMS sessions, have two brain MRI scans, take a single dose of D‑Cycloserine on the TMS day, and complete brief weekly and monthly visits plus a daily survey.
- Time commitment
- The trial lasts about 6 months, with weekly visits for 12 weeks, monthly follow‑ups for 6 months, and daily online surveys.
- 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 is enrolling
- Boston, Massachusetts, 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 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?
This study is enrolling now at Boston, Massachusetts, 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.