Nicotine Addiction

10

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

Condition / disease
Location
Status: Recruiting

Non-Invasive Deep Brain Neuromodulation for Smoking Cessation

This study will develop novel low intensity focused ultrasound (LIFU) therapy to help people to quit cigarette smoking. Smoking is associated with cancers of the lung. Available smoking cessation methods help many to quit. However, for the many who continue to smoke despite the strong desire to quit and after exhausting existing therapeutic approaches, new treatment methods are needed. Without more effective treatment, many will continue to smoke, and our progress on cancer prevention through smoking cessation may decelerate as these associated cancer risks will remain. Brain imaging research has identified specific areas of the brain linked to severe nicotine addiction, but up to now there are no effective ways to directly target most of these deeper brain regions. LIFU is a new and safe method to modulate brain functions that can either inhibit overactive activity or restore normal activity levels. The purpose of this study is to provide a novel ultrasound-based neuromodulation strategy for smoking cessation in people who have difficulty to quit smoking despite numerous serious attempts in their lives. LIFU works by sending acoustic pressure modulating neural activity in the human brain.

Participants needed: 100
Trial details
Age: 20-60Biological sex: AllType: InterventionalSponsor: The University of Texas Health Science Center, HoustonUpdated: Jun 23, 2026Locations: 1
Eligibility criteria

Must be a smoker for 5 or more years and within 20 to 60 years of age [+1]

Must not have ongoing unstable medical, neurological or psychiatric illness as d... [+8]

Status: Recruiting

Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community

Theoretical Framework: Cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with Substance Use Disorders (SUD). Smoking exacerbates both physical and mental health issues, further complicating the treatment of SUD. Current therapeutic approaches for SUD often prove inadequate, indicating a need for new strategies. Recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction. Objectives: This study aims to investigate the therapeutic potential of smoking cessation for individuals with SUD, using a six-week intervention within a therapeutic community. The research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. It is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems. Methods: A randomized controlled trial (N=150) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants with SUD (n=100) will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. Metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. Assessments on a behavioural level will take place at a 3-months follow-up. A cross-sectional, non-interventional healthy control group (n=50) will be examined at a single timepoint with an anologous panel of psychological variables, blood and stool to ascertain differences between smokers with SUD and healthy controls.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Sigmund Freud PrivatUniversitatUpdated: May 18, 2026Locations: 3
Eligibility criteria

diagnosis of a form of substance use disorder (F1x.x) by a licensed psychiatrist... [+7]

lack of consent, inability to provide informed consent [+8]

Status: Recruiting

Semaglutide for Smoking Cessation in Patients With Diabetes

To assess the feasibility of conducting a randomized controlled trial (RCT) to determine the effectiveness of semaglutide as an adjunct to combination NRT in supporting smoking cessation for patients with diabetes.

Participants needed: 100
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Ottawa Heart Institute Research CorporationUpdated: May 11, 2026Locations: 1
Eligibility criteria

Adults (18 years or older) with type 2 diabetes [+5]

Pregnant or breastfeeding individuals [+15]

Status: Recruiting

Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder

The proposed project will include enrollment of 200 daily tobacco cigarette users, ages 22+, from the San Diego community. Participants will be assessed on the VR Nicotine Cue Exposure paradigm then randomized (stratified on age and sex) to receive varenicline (target dose 1mg twice daily) or placebo (n per group=100; total N=200). Following eight days of titration, participants will be assessed again on the VR Nicotine Cue Exposure paradigm. They will then be followed via mobile assessments for eight days on target dose of varenicline, and 30-days post assessment by phone, to assess short-term nicotine use behaviors.

Participants needed: 200
Trial details
Phase: Early Phase 1Age: 22+Biological sex: AllType: InterventionalSponsor: University of California, San DiegoUpdated: Mar 16, 2026Locations: 1
Eligibility criteria

Provision of signed and dated informed consent form [+7]

Contraindications/conditions with special precautions for varenicline treatment... [+5]

Status: Recruiting

Effect of Product Characteristics on the Abuse Liability of Nicotine Pouches

The goal of this study is to assess the effects of nicotine concentration and its interplay with pH on sensory experience, product appeal, and abuse liability of NPs among young adults NP users. Primary objective is to assess the effect of variation in nicotine concentration in nicotine pouches (NPs) and its interaction effect with pH level on three proximal outcomes of relevance to regulation: (1) sensory experience, (2) product appeal, and (3) abuse liability of NPs.

Participants needed: 84
Trial details
Age: 21-35Biological sex: AllType: InterventionalSponsor: Emory UniversityUpdated: Feb 27, 2026Locations: 1
Eligibility criteria

Current established users of nicotine pouches (have used nicotine pouches in the... [+4]

Planning to cut down or quit using nicotine in the next 30 days [+2]

Status: Recruiting

Circuitry-Guided Smoking Cessation in Schizophrenia (UH3)

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from F8 coil or active rTMS from H coil for smoking cessation. Smoking and brain functional connectivity changes will be assessed at baseline, different stages of rTMS and/or follow-ups.

Participants needed: 50
Trial details
Age: 22-65Biological sex: AllType: InterventionalSponsor: The University of Texas Health Science Center, HoustonUpdated: Jan 12, 2026Locations: 1
Eligibility criteria

Male and female between ages 22-65 years [+5]

Persons with a first-degree relative with inherited epilepsy, seizure disorder,... [+10]

Status: Recruiting

CONNECT Cancer Survivors With Tobacco Treatment

The purpose of this study is to evaluate the comparative effectiveness of two different informatics-enabled implementation strategies on increasing tobacco treatment and improving smoking cessation rates for cancer control and prevention. This will be done via a two-arm pragmatic cluster randomized trial (CRT) to test the effectiveness of nudges to change (ELEVATE-S) vs. quit-focused usual care (ELEVATE) in increasing tobacco treatment (use of medication, brief advice, or referral to external counseling) and smoking cessation.

Participants needed: 5,000
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Washington University School of MedicineUpdated: Jan 8, 2026Locations: 1
Eligibility criteria

Be receiving care at a participating clinic [+3]

Status: Recruiting

Unraveling the Genetic Basis of Nicotine Addiction for Novel Therapeutic Strategies

This case-control study aims to investigate the genetic and molecular bases of nicotine addiction to identify potential therapeutic targets. The project will involve drug repurposing using Mendelian Randomization, a smoking cessation intervention, and the analysis of methylation status in participants undergoing nicotine withdrawal.

Participants needed: 200
Trial details
Age: 18-60Biological sex: AllType: ObservationalSponsor: University of CyprusUpdated: Jun 25, 2024Locations: 1
Eligibility criteria

Adults aged 18-60 years old [+3]

Presence of significant uncontrolled medical conditions (e.g. cardiovascular dis... [+4]

Status: Recruiting

Biopsychosocial Predictors of Nicotine Relapse

This study aims to investigate the associations between emotion regulation ability, stress-induced neural activity changes, and susceptibility to relapse in smokers attempting to quit. Participants will undergo assessments of emotion regulation, neural activity via quantitative electroencephalography (qEEG), and stress responses before and during a 24-hour nicotine abstinence period. They will then participate in a computerized smoking cessation intervention, and their abstinence status will be monitored for 6 months.

Participants needed: 200
Trial details
Age: 18-60Biological sex: AllType: InterventionalSponsor: University of CyprusUpdated: Jun 24, 2024Locations: 1
Eligibility criteria

Age 18-60 years [+3]

Presence of psychiatric or medical treatment [+5]

Status: Recruiting

Effectiveness of Combined Tobacco Treatment in Hospitalized Subjects

In the 20th century, tobacco caused the death of 100 million people worldwide and it is estimated that it will be responsible for 1 billion deaths in the 21st century. Currently 8 million people die each year from smoking, 7 million are associated with active smoking, thus being the main risk factor for loss of disability-adjusted life years for men and the ninth most important risk factor for women. In previous studies it has been reported that approximately 21% (14%-30%) of subjects who have required hospitalization are active smokers, being higher in men than in women (28% vs 14%). The initiation of treatment for smoking cessation in this group of subjects has shown an effectiveness rate of up to 65% to maintain abstinence 6 to 12 months after discharge. The effectiveness has been analyzed in scenarios with only brief advice, in some others with the use of medications such as varenicline, bupropion and nicotine replacement therapy, however, the interventions have not been standardized for adequate analysis, which could contribute to the different results.

Participants needed: 134
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: National Institute of Respiratory Diseases, MexicoUpdated: Feb 23, 2024Locations: 1
Eligibility criteria

Subjects who have had pharmacological treatment to stop smoking in the last mont... [+1]