Smoking Cessation

118

Review clinical trials related to Smoking Cessation. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

The investigators aim to address the following specific aims: * Determine the efficacy of Prog in preventing postpartum smoking relapse and reducing smoking relapse risk factors. * Examine the effects of this maternal smoking intervention on infant health. * Examine racial and ethnic differences in intervention outcomes.

Participants needed: 171
Trial details
Phase: Phase 4Age: 18-45Biological sex: FemaleType: InterventionalSponsor: University of MinnesotaUpdated: Jul 13, 2026Locations: 1
Eligibility criteria

Ability to provide informed consent, [+8]

Current daily use of nicotine replacement therapy or smoking cessation medicatio... [+4]

Status: Recruiting

Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)

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. The main question it aims to answer is: Does receiving active enhanced aTMS + varenicline lead to higher abstinence rates and lower nicotine craving? Participants will be asked to: * Complete 2 brain MRI scans * Take varenicline every day for 12 weeks * Quit using nicotine products at the end of the second week of varenicline * Complete one day of up to 20 TMS treatments * Take a single dose of D-Cycloserine medication on the day of TMS treatment * Complete 12 brief, weekly follow-up visits * Complete a brief daily survey each day that they take the study drug

Participants needed: 30
Trial details
Phase: Phase 4Age: 18-65Biological sex: AllType: InterventionalSponsor: Massachusetts General HospitalUpdated: Jul 13, 2026Locations: 1
Eligibility criteria

Age ≥ 18 and ≤65; [+6]

Pregnancy or breastfeeding; [+12]

Status: Recruiting

My Path to Quit Tobacco

The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term cessation and other key patient-centered outcomes compared to the usual evidence-based standard of care: services provided by a state-run quitline. This study compares the relative effectiveness of three different treatments (Standard, Intensive, and Intensive Incentivized) on long-term smoking cessation (biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day) among Black adults who smoke and want to quit.

Participants needed: 1,550
Trial details
Phase: Phase 4Age: 21+Biological sex: AllType: InterventionalSponsor: University of Wisconsin, MadisonUpdated: Jul 1, 2026Locations: 5
Eligibility criteria

self-identify as Black [+3]

currently taking bupropion for non-smoking cessation reasons

Status: Not yet recruiting

Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2026: Engagement-Focused GenAI-based Chatbot for Real-Time Smoking Cessation Support

The goal of this trial is to learn if chatbot-based instant messaging works to help smoking cessation in general adult smokers. It will also learn about the experience, attitude, and perception of using an LLM-based chatbot. The main questions it aims to answer are: 1. Will an engagement-focused LLM-based chatbot smoking cessation intervention have a non-inferior validated abstinence rate than the control group? 2. Will an LLM-based chatbot smoking cessation intervention have a non-inferior self-reported abstinence rate, smoking reduction rate, and smoking cessation services use rate than the control group? Researchers will compare an LLM-based chatbot smoking-cessation intervention to a human-led instant messaging support group (brief advice based on AWARD and personalised active referral) to determine whether chatbot-based instant messaging support promotes smoking cessation. Participants in the intervention group will receive: 1. AWARD advice 2. Personalised active referral 3. 12 weeks of chatbot-based instant messaging support (via WhatsApp)

Participants needed: 998
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: The University of Hong KongUpdated: Jun 30, 2026Locations: 1
Eligibility criteria

Hong Kong residents aged 18 years or above [+6]

Smokers who have communication barriers (either physical or cognitive) [+1]

Status: Recruiting

Preliminary Effectiveness of Enhanced Text Message + Incentives

This study is a preliminary evaluation of a smoking cessation intervention designed for pregnant women that combines text message support and financial incentives. The aims of this study are to determine the preliminary feasibility and acceptability of text message + incentives (intervention) vs. text message only (control).

Participants needed: 50
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of Kansas Medical CenterUpdated: Jun 30, 2026Locations: 1
Eligibility criteria

Pregnant women aged: 18+ [+4]

Not at all interested in quitting [+2]

Status: Recruiting

Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS

The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.

Participants needed: 800
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: H. Lee Moffitt Cancer Center and Research InstituteUpdated: Jun 26, 2026Locations: 3
Eligibility criteria

1) being aged ≥18 years [+5]

1) history of a medical condition that precludes use of nicotine replacement the... [+2]

Status: Not yet recruiting

Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors

Tobacco use remains the leading cause of preventable death, causing over 400,000 annual deaths in the United States alone. Smartphone-based interventions, particularly those leveraging real-time adaptive messaging, represent a promising yet underutilized approach to delivering personalized tobacco and cannabis treatment. The investigator's ongoing NCI funded micro-randomized trial (MRT; R01 CA246590) has shown initial feasibility in reducing smoking urges through situationally tailored cognitive-behavioral therapy (CBT) and mindfulness-based acceptance and commitment-based therapy (ACT) messages triggered by real-time contextual data (e.g., geolocation, momentary stress). To advance from a static MRT framework to a dynamic, data-driven just-in-time adaptive intervention (JITAI), this project aims to develop, test, and refine a reinforcement learning (RL) algorithm that can continuously adapt to user needs in real-time, enhancing treatment outcomes for various tobacco and cannabis products. To ensure optimal usability and engagement, the investigators will conduct user-centered testing with the developed RL-based intervention delivery in one cohort (N=7) over 45 days. This will include usability assessment via the System Usability Scale, analysis of app interaction metrics, and semi-structured interviews to gather feedback for refining message content, timing, and design.

Participants needed: 7
Trial details
Age: 18-40Biological sex: AllType: InterventionalSponsor: Johns Hopkins Bloomberg School of Public HealthUpdated: Jun 25, 2026Locations: 1
Eligibility criteria

live in the U.S.; [+6]

None

Status: Recruiting

PASCAL Feasibility Study

The goal of this randomized study is to assess if a conversational agent (or chatbot) that the investigators have developed to help with quitting smoking is acceptable to people trying to quit smoking and to also collect initial information regarding its effectiveness. In this study, some participants trying to quit smoking will be provided with this chatbot while other participants will not be

Participants needed: 120
Trial details
Age: 21+Biological sex: AllType: InterventionalSponsor: University of MinnesotaUpdated: Jun 24, 2026Locations: 1
Eligibility criteria

Identify as Black or African American [+8]

Medicinal nicotine use would require careful monitoring by a healthcare professi... [+2]

Status: Recruiting

A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation

The purpose of this study is to provide preliminary evidence for the efficacy of 12 weeks of vagal nerve stimulation (VNS) and nicotine replacement therapy (NRT) for increasing smoking abstinence rates.

Participants needed: 150
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Mayo ClinicUpdated: Jun 23, 2026Locations: 1
Eligibility criteria

18 years of age or older at the time of consent. [+5]

Patients with a current moderate/severe depression as assessed by a score of ≥10... [+14]

Status: Not yet recruiting

Pain and Smoking Study - Interactive Voice Response

PASS2 aims to expand upon the recently completed study (PASS intervention), which tested the telephone delivery of a cognitive behavioral intervention (CBI). This study will use Interactive Voice Response (IVR) to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.

Participants needed: 220
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Jun 23, 2026Locations: 1
Eligibility criteria

being an enrolled Veteran at VACHS; [+3]

active diagnosis of dementia or psychosis in medical record; [+9]

Status: Recruiting

The Options 2 Study

The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products. Participants will: * Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks. * Have 6 in-person research visits and 1 follow-up call * Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use

Participants needed: 300
Trial details
Phase: Phase 4Age: 21+Biological sex: AllType: InterventionalSponsor: University of Wisconsin, MadisonUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

≥ 21 years old (i.e., able to legally purchase tobacco products) [+7]

currently in treatment for psychosis or bipolar disorder [+2]

Status: Recruiting

Rural Smoking Cessation

Understanding ways to help people who live in rural areas quit smoking is a public health priority. quitting smoking among rural people who smoke is a critical public health concern. People in rural areas smoke at higher rates than those in urban areas, experience high rates of smoking caused cancers and deaths. We are recruiting rural people from around the country to better understand how different quit smoking methods can improve a person's chances of successfully quitting smoking.

Participants needed: 272
Trial details
Age: 21+Biological sex: AllType: InterventionalSponsor: Masonic Cancer Center, University of MinnesotaUpdated: Jun 18, 2026Locations: 1
Eligibility criteria

≥ 21 years [+2]

past 30-day NRT use or contraindications listed on the NRT labels [+1]

Status: Not yet recruiting

Gen AI Powered Behavioral Support Plus Chewing Gum Intervention for Construction Workers Who Smoke

The goal of this pilot trial is to learn if 1-week NRT sampling, 3-week chewing gum, and 12-week chatbot-delivered instant messaging support works to help smoking cessation in construction workers who smoke. It will also learn about the feasibility, acceptability, and preliminary effectiveness of delivering the comprehensive intervention in construction settings. The main questions it aims to answer are: 1. Will the integrated intervention, comprising NRT sampling, chewing gum, and chatbot-delivered instant messaging support, show feasibility, acceptability, and appropriateness for delivery in construction worksite settings? 2. Will participants who receive the comprehensive intervention have a higher validated abstinence rate than those who receive NRT sampling alone? Researchers will compare the integrated intervention, comprising NRT sampling, chewing gum, and chatbot-delivered instant messaging support, to the standard care group (NRT sampling alone) to see if the integrated intervention works to promote smoking cessation. Participants in the intervention group will receive: 1. AWARD advice and brief video 2. 1-week NRT sampling 3. 3-week chewing gum 4. 12-week chatbot-based instant messaging support (via WhatsApp)

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: The University of Hong KongUpdated: Jun 17, 2026Locations: 1
Eligibility criteria

Hong Kong residents aged 18 or above [+6]

Smokers who are participating in other smoking cessation programmes [+2]

Status: Not yet recruiting

Smoking Cessation Counseling Performance Among Medical Interns

Smoking remains one of the leading preventable causes of morbidity and mortality worldwide and is strongly associated with chronic respiratory diseases, cardiovascular disease, cancer, and premature death. Physicians play a central role in tobacco control through the delivery of smoking cessation counseling, and even brief physician advice has been shown to significantly increase smoking quit rates. The evidence-based 5A's model (Ask, Advise, Assess, Assist, and Arrange) is widely recommended as the standard framework for smoking cessation counseling.

Participants needed: 140
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assiut UniversityUpdated: Jun 16, 2026Locations: 1
Eligibility criteria

Medical interns enrolled in the internship training program at the Faculty of Me... [+1]

Previous formal structured training in smoking cessation counseling based on the... [+4]

Status: Recruiting

CONNECTing to LungCare

This study evaluates a smoking cessation intervention (CONNECTing to LungCare) for improving shared decision-making conversations about smoking cessation and lung cancer screening between patients and providers. Shared decision making is a patient care model in which providers offer information regarding risks and benefits, patients express their values and preferences, and then healthcare decisions are jointly discussed between the patient and provider. Patient education, aided by decision support tools, can increase patients' knowledge, decrease their decisional conflict, promote decision making, and improve the patients' perception of risk. CONNECTing to LungCare is an interactive education intervention that addresses lung cancer screening and smoking cessation and provides participants with a tailored summary that may make them more likely to have shared decision-making discussions with their providers about smoking cessation and lung cancer screening.

Participants needed: 152
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of California, San FranciscoUpdated: Jun 15, 2026Locations: 1
Eligibility criteria

English, Spanish and Cantonese speaking [+3]

Not a current smoker

Status: Recruiting

Phone Enabled Implementation of Cessation Support

The tobacco use burden in Lebanon is exceptionally high: 35% of adults are current cigarette smokers and 39% are current waterpipe smokers. Although the World Health Organization endorses evidence-based interventions for population-level tobacco dependence treatment, recommended treatments are not integrated as a routine part of primary care in Lebanon, as is the case in other low-resource settings. The objective of this proposal is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based cessation treatment in Lebanon's national system of primary health care centers.

Participants needed: 1,500
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of FloridaUpdated: Jun 12, 2026Locations: 1
Eligibility criteria

Age 18+ [+5]

Patients who use other tobacco products including vape exclusively. [+3]

Status: Recruiting

Evaluating Smoking Cessation Interventions for PWH in South Africa

The overall objective of the study is to optimize a smoking cessation treatment package for people with HIV (PWH) that can be integrated into existing HIV care in South Africa.

Participants needed: 660
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Jun 9, 2026Locations: 1
Eligibility criteria

≥18 years of age, and [+6]

Currently (within the previous 14 days) receiving or using smoking cessation cou... [+10]

Status: Not yet recruiting

THCV Treatment for Smokers

This study will randomize 32 non-treatment-seeking individuals who smoke cigarettes daily into a randomized, crossover, double-blind, placebo-controlled study testing the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV).

Participants needed: 32
Trial details
Phase: Phase 2Age: 21-65Biological sex: AllType: InterventionalSponsor: University of California, Los AngelesUpdated: Jun 9, 2026
Eligibility criteria

Be between the ages of 21 and 65; [+7]

Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any... [+14]

Status: Recruiting

Healthy Family Project: Tobacco Use and Smoke Exposure in Asian American Communities

This study evaluates whether the Smokefree Family Living (SFL) intervention improves quit rates (smoking cessation) and exposure to tobacco contamination that stays in items such as, carpets, walls, and furniture, even after the smoke has cleared (third-hand smoke (THS)) among Chinese American smokers and their non-smoking household members. Smoking remains high among Chinese American males with limited ability to speak English. This causes the non-smoking household members to be exposed to THS, which contains many of the same harmful components as smoking and becomes more toxic as it ages. SFL is tailored for Chinese Americans and combines the contents of the Quit Smoking for a Healthy Family (QS) intervention with additional THS education and cleaning strategies. QS focuses on smoking cessation through educational sessions and support. THS education and cleaning strategies provide information on THS and how to clean the home for THS. SFL may help Chinese American smokers and their non-smoking household members learn about the importance of quitting and the dangers of THS, this may improve smoking cessation and reduce THS exposure

Participants needed: 760
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of California, San FranciscoUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

Must be 18 years of age or older. [+13]

Currently participating in another smoking cessation program. [+5]

Status: Not yet recruiting

LLM Intervention for Tobacco in Underserved Populations (LIFT-UP)

This study will test a tailored, multilingual tobacco cessation chatbot called LIFT-UP (LLM Intervention for Tobacco in Underserved Populations), designed to better meet the needs of people living in persistent poverty census tracts. This study will use 1:1 semi-structured interviews to explore social drivers of health impacting TC, as well as digital access and preferences among those living in PPCTs. This qualitative approach enables guided yet flexible exploration of key domains while capturing unanticipated insights relevant to refining the chatbot.

Participants needed: 22
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of UtahUpdated: Jun 3, 2026Locations: 1
Eligibility criteria

18+ years old [+5]

None

Status: Not yet recruiting

3A-OR Very Brief Tobacco Cessation Intervention in Primary Care

Introduction: Türkiye is far from the World Health Organization (WHO)'s target of reducing tobacco use prevalence by 30% by 2025. Most tobacco users consider quitting, and most have attempted to quit at least once. However, the success rate of quitting on one's own is quite low. Studies demonstrating that very brief tobacco cessation interventions delivered by healthcare professionals increase cessation rates have almost entirely been conducted in hospital settings. The aim of this trial is to investigate the effectiveness of implementing the 3A-OR (Ask - Assess - Advise - Offer Assistance - Record) very brief tobacco cessation intervention in routine primary care family medicine practice on the success of tobacco cessation. Methods/design: This protocol describes a two-arm, multicenter pragmatic trial for adolescent and adult tobacco users. The project will be carried out in family health centers in 21 study sites across the 12 statistical regions of Türkiye. In the intervention arm, volunteer family physicians will implement the 3A-OR very brief tobacco cessation intervention to their patients as part of their routine clinical practice. The intervention consists of the following steps: 'asking patients about their tobacco use status', 'assessing users' motivation to quit', 'advising quitting based on their motivation status', 'offering cessation assistance', and 'recording information regarding patients' tobacco use status and repeating the intervention at each patient contact'. Routine practice in family health centers will constitute the control group. Data will be collected using standard questionnaire forms at baseline and during follow-up interviews at 3, 6, and 12 months. Tobacco cessation rate and increase in smokers' motivation were the primary outcomes of the trial. Discussion: If the 3A-OR very brief tobacco cessation intervention is found to be effective, the results of this trial will provide evidence that will encourage the widespread use of the intervention in primary care family health centers. The study results are intended to be disseminated through the Family Medicine Academy Association website, conference presentations, and scientific publications.

Participants needed: 2,400
Trial details
Age: 15+Biological sex: AllType: InterventionalSponsor: Aydin Adnan Menderes UniversityUpdated: May 27, 2026Locations: 1
Eligibility criteria

Being aged 15 years and older (including pregnant and breastfeeding women); [+5]

Using tobacco products less than once per day; [+3]

Status: Not yet recruiting

ChatGPT-Supported Text Messaging Program for Smoking Cessation

The current research proposal aims to explore how a purpose driven LLM ChatGPT chatbot, BeFreeBot, might enhance an evidence-based text messaging smoking cessation program, BeFree. The research will consist of a formative evaluation comparing quitting related outcomes among users of BeFree+Bot and BeFree.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: George Washington UniversityUpdated: May 22, 2026Locations: 1
Eligibility criteria

lives in the US [+3]

none

Status: Recruiting

Multi-Site Trial of Tirzepatide for Smoking Cessation

This multi-site clinical trial will generate data on the efficacy of tirzepatide for smoking cessation and associated outcomes (e.g., post-cessation weight gain) in treatment-seeking people who smoke (PWS) with overweight or obesity. A sample of 300 treatment-seeking people who smoke with body mass index of 25 kg/m2 or greater will be recruited from four geographic sites (University of Southern California, Yale University, University of Chicago, and University of Colorado Anschutz Medical Campus) to participate in a parallel-arm, dose-escalating, placebo-controlled trial. Participants will attend weekly clinic visits to receive subcutaneous tirzepatide or placebo over 16 weeks (Visit Weeks 1-16), followed by follow-up visits at Week 17 and Week 27. Medication will be prescribed according to the standard dose titration schedule for the first 16 weeks of treatment (initial dose: 2.5mg/week; final dose: 10mg/week). All participants will also receive nicotine patches.

Participants needed: 300
Trial details
Phase: Phase 2Age: 21-65Biological sex: AllType: InterventionalSponsor: University of Southern CaliforniaUpdated: May 22, 2026Locations: 4
Eligibility criteria

Age 21-65 years [+8]

BMI < 25 kg/m2 at screening [+24]

Status: Not yet recruiting

Evaluating the Impact of CONNECT in a Multilingual Population

This study aims to broaden the reach of the lung cancer screening (LCS) CONNECT program (NCT04149249, NCT06213532), by developing a version of the program to be available to multilingual communities. The CONNECT program encourages individuals who are undergoing lung cancer screening to also quit smoking by providing a personalized program which includes a video doctor with personalized responses, text message and telephone call support and connection with a pharmacist to assist in obtaining nicotine replacement medication. This clinical trial will develop and ultimately test how well the CONNECT Multilingual (CONNECT ML) program works to improve smoking cessation among current adult smokers within the Spanish and Cantonese speaking communities.

Participants needed: 439
Trial details
Age: 50-80Biological sex: AllType: InterventionalSponsor: University of California, San FranciscoUpdated: May 22, 2026Locations: 1
Eligibility criteria

Age 50-80 years old. [+4]

Non-smokers. [+4]

Status: Recruiting

Testing an MBI for Smoking Cessation and Alcohol Use Among Cancer Survivors

This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.

Participants needed: 600
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: H. Lee Moffitt Cancer Center and Research InstituteUpdated: May 18, 2026Locations: 1
Eligibility criteria

≥18 years old [+6]

Pregnancy or lactation [+5]