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Home › Conditions › Tobacco Dependence

Tobacco Dependence

Subtypes of Tobacco Dependence

Nicotine Addiction 2 Nicotine Use Disorder 2

4 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Tobacco Dependence

45 trials tracked for Tobacco Dependence: 14 in phase 3 or 4 and 3 with published results. The most-cited published study has 112 citations.

45Trials tracked
14Phase 3 & 4
0Recruiting
3With published results
Phase distribution
Phase 4 7 Phase 3 7 Phase 2 3 Phase 1 1 Other / NA 27
  1. Phase 3 Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study Completed · 112 cited
  2. Phase 4 UW Quitting Using Intensive Treatment Study (QUITS) Completed · 59 cited
  3. Phase 3 Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy Completed · 12 cited
  4. Phase 4 Varenicline OTC Trial on Efficacy and Safety Completed
  5. Phase 4 Varenicline for Co-occurring Cannabis and Tobacco Use Completed
  6. Phase 4 Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community Completed
Show 39 more trials
  1. Phase 4 Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment Completed
  2. Phase 4 Bupropion SR Plus Counseling for Smoking Cessation Completed
  3. Phase 4 Smoking Cessation Intervention: Effectiveness in Primary Care Completed
  4. Phase 3 Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence Completed
  5. Phase 3 Varenicline Treatment for Active Alcoholic Smokers Completed
  6. Phase 3 S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence Completed
  7. Phase 3 Use of Varenicline for 4-weeks Prior to Quitting Completed
  8. Phase 3 Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction Completed
  9. Phase 2 Effects of Naltrexone on Nicotine Reinforcement Completed
  10. Phase 2 UW Withdraw From Tobacco Study Completed
  11. Phase 2 CO Monitoring for Tobacco Cessation in Quitlines Completed
  12. Phase 1 Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence Completed
  13. N/A Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. Completed
  14. N/A Personalized Feedback for Distress Intolerant Smokers Completed
  15. N/A Cigarette Smoking in Smokers With and Without Schizophrenia Completed
  16. N/A Predictors of Treatment Outcome for Smokers With and Without Schizophrenia Completed
  17. N/A Clinical Trial of Smoking Cessation Mobile Phone Program Completed
  18. N/A Measuring Neuroadaptations in Response to Very Low Nicotine Content Cigarettes Completed
  19. N/A Novel Determinants and Measures of Smokeless Tobacco Use: Study 1 Completed
  20. N/A Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes Completed
  21. N/A Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab Completed
  22. N/A Tobacco Dependence Treatment for Asian Americans Completed
  23. N/A Addictive Potential of LCCs in Dual Users Completed
  24. N/A Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes Completed
  25. N/A Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation Completed
  26. N/A Using a Teachable Moment Communication Process to Improve Outcomes of Quitline Referrals Completed
  27. N/A European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS) Completed
  28. N/A Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers Completed
  29. N/A Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement Completed
  30. N/A Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry Completed
  31. N/A Behavioral Activation for Smoking Cessation in PTSD Completed
  32. N/A A Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients Completed
  33. N/A Innovative Digital Therapeutic for Smoking Cessation Completed
  34. N/A Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status Completed
  35. N/A Helping Poor Smokers Quit Completed
  36. N/A Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product Completed
  37. N/A Low Nicotine Cigarettes Plus Electronic Cigarettes Completed
  38. N/A Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders Completed
  39. N/A Web Assisted Tobacco Intervention With Community Colleges Completed

Showing the 45 most-cited and recently-updated of 45 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Tobacco Dependence: what the trials found

Varenicline has demonstrated significant efficacy in promoting smoking cessation and reducing physiological markers of tobacco use. Trials showed statistically significant improvements in prolonged smoking abstinence at both 12 weeks 12 and 24 weeks 12. Additionally, varenicline was associated with significant reductions in pre-quit carbon monoxide (CO) levels 14 and cotinine levels 14, while showing no significant difference in reported urges to smoke compared to other treatments 14. Varenicline also showed evidence of reducing peak craving scores 19 and improving smoking satisfaction scores 19.

Nicotine replacement therapies (NRT) show varying results across different delivery methods. Nicotine spray demonstrated statistically significant increases in continuous smoking abstinence at 6 weeks 10, 12 weeks 10, and 26 weeks 10. Nicotine gum showed varied point prevalence smoking abstinence rates 8, while nicotine lozenges were evaluated for tobacco abstinence at 12 weeks 13.

Other interventions show mixed or specific results. Bupropion combined with counseling did not show a statistically significant difference in point prevalence abstinence at 6 months 6. S-adenosyl-L-methionine showed no significant difference in smoking abstinence at 8 weeks 15. Omega-3 supplementation was associated with changes in nicotine dependence scores and docosahexaenoic acid (DHA) concentrations over 90 days 11.

Recent results — preliminary, needs further review

  • • Normal nicotine content research cigarettes were associated with significantly lower urinary NNAL levels compared to other groups 20.
  • • Flavored and unflavored little cigars/cigarillos (LCCs) were evaluated in a recent study 1.

For the clinician treating this condition

  • Varenicline is supported by evidence for increasing prolonged abstinence, reducing cotinine levels, and lowering peak craving scores.
  • Nicotine spray showed statistically significant improvements in continuous smoking abstinence over a 26-week period.
  • While several NRT methods (gum, lozenges) were studied, nicotine spray demonstrated the most consistent statistically significant results for sustained abstinence.

AI synthesis of 11 cited trials, updated Jun 26, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Nicotinic partial agonists show no effect on opioid use in HIV-positive smokers
Infectious Disease RCT
Nicotinic partial agonists show no effect on opioid use in HIV-positive smokers New data on nicotine treatment for HIV patients who use opioids
This secondary analysis of a randomized trial in 97 HIV-positive smokers with risky alcohol use and baseline opioid use found no significant…
A new look at nicotine treatment for HIV patients who use opioids found no difference in opioid use between two drug groups.
May 1, 2026
Report examines state Medicaid coverage of tobacco cessation treatments and access barriers
Infectious Disease
Report examines state Medicaid coverage of tobacco cessation treatments and access barriers Report examines state Medicaid coverage for quitting tobacco and access barriers
A report describes state Medicaid coverage of tobacco cessation treatments and barriers to accessing these treatments in the United States.
A new report maps how state Medicaid programs cover tobacco quit treatments and highlights access barriers for patients.
CDC Apr 4, 2026
Observational study examines smoking cessation advice from health professionals to US adults
Infectious Disease
Observational study examines smoking cessation advice from health professionals to US adults How many smokers get told to quit by their doctor?
An observational study assessed the percentage of current cigarette smokers aged ≥18 years in the United States who received advice from a h…
A new study looked at how often doctors and nurses tell their patients who smoke that they should quit.
CDC Apr 4, 2026
Report describes U.S. adults' intent and methods for smoking cessation
Infectious Disease
Report describes U.S. adults' intent and methods for smoking cessation Report examines how U.S. adults plan to quit smoking, but findings are not yet available
An observational report describes smoking cessation intentions and methods among U.S.
A new report looks at how U.S. adults plan to quit smoking, but the specific findings have not been released yet.
CDC Apr 4, 2026