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Home › Conditions › Nicotine Dependence

Nicotine Dependence

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for Nicotine Dependence

137 trials tracked for Nicotine Dependence: 35 in phase 3 or 4 and 12 with published results. The most-cited published study has 183 citations.

137Trials tracked
35Phase 3 & 4
0Recruiting
12With published results
Phase distribution
Phase 4 21 Phase 3 14 Phase 2 39 Phase 1 10 Other / NA 53
  1. Phase 4 A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers Completed · 183 cited
  2. Phase 3 Varenicline for Adolescent Smoking Cessation Completed · 112 cited
  3. Phase 3 Maintaining Nonsmoking Completed · 73 cited
  4. Phase 3 Varenicline for Nicotine Dependence Among Those With HIV/AIDS Completed · 46 cited
  5. Phase 4 Varenicline for Nicotine Vaping Cessation in Adolescents Completed · 38 cited
  6. Phase 3 Extended Cessation Treatment for Teen Smokers Completed · 24 cited
Show 44 more trials
  1. Phase 3 Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace Completed · 23 cited
  2. Phase 4 Nicotine Replacement for Smoking Cessation During Pregnancy Completed · 21 cited
  3. Phase 4 Progesterone and Brain Imaging Study Completed · 13 cited
  4. Phase 4 Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers Completed · 12 cited
  5. Phase 4 Research and Innovation to Stop E-cigarette/Vaping in Young Adults Completed · 5 cited
  6. Phase 3 Comparing NicoBloc to Nicotine Lozenges Completed
  7. Phase 4 Treatment of Nicotine Dependence and Acute Depression Completed
  8. Phase 4 Stress Neuroadaptation in Tobacco Dependence Completed
  9. Phase 4 Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging Completed
  10. Phase 4 Bupropion for ADHD in Adolescents With Substance Use Disorder Completed
  11. Phase 4 Effects of Intranasal Oxytocin on Cigarette Smoking Completed
  12. Phase 4 Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness Completed
  13. Phase 4 Identifying Treatments to Motivate Smokers to Quit Completed
  14. Phase 4 Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers Completed
  15. Phase 4 Evaluation of National Cancer Institute (NCI) Smoking Intervention Resources Completed
  16. Phase 4 Identifying Optimal Smoking Cessation Intervention Components (Cessation) Completed
  17. Phase 4 An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence Completed
  18. Phase 4 Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms Completed
  19. Phase 4 Measuring Smoking Behaviors While Using Varenicline Completed
  20. Phase 4 Helping Those With Mental Illness Quit Smoking Completed
  21. Phase 4 Evaluation of Treatments to Improve Smoking Cessation Medication Adherence Completed
  22. Phase 3 Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation Completed
  23. Phase 3 Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms Completed
  24. Phase 3 Extended Varenicline Treatment for Smoking Among Cancer Patients Completed
  25. Phase 3 Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence Completed
  26. Phase 3 Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence Completed
  27. Phase 3 New Treatment for Alcohol and Nicotine Dependence Completed
  28. Phase 3 Smoking-Cessation and Stimulant Treatment (S-CAST) Completed
  29. Phase 3 Concurrent Bupropion / Varenicline for Smoking Cessation Completed
  30. Phase 2 AXS-05 Phase II Trial on Smoking Behavior Completed
  31. Phase 2 Efficacy of Varenicline in Ambivalent Smokers Completed
  32. Phase 2 Treatment of Smoking Among Individuals With PTSD Completed
  33. Phase 2 Effects of Varenicline on Smoking Reminders Completed
  34. Phase 2 Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation Completed
  35. Phase 2 A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers Completed
  36. Phase 2 Health Effects of SLT, Cigarette Smoking, and New Tobacco Products Completed
  37. Phase 2 St. John's Wort for Tobacco Cessation Completed
  38. Phase 2 Baclofen Effects in Cigarette Smokers Completed
  39. Phase 2 Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers Completed
  40. Phase 2 Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity Completed
  41. Phase 2 Selegiline for Smoking Cessation - 1 Completed
  42. Phase 2 Smoking, Sex Hormones, and Pregnancy Completed
  43. Phase 2 Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes Completed
  44. Phase 2 Adaptive Pharmacotherapy for Smoking Cessation Completed

Showing the 50 most-cited and recently-updated of 137 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

Nicotine Dependence: what the trials found

Varenicline has demonstrated significant efficacy in achieving nicotine vaping abstinence. Specifically, double-blind administration showed significantly higher rates of continuous 4-week nicotine vaping abstinence at the end of treatment (Weeks 9-12) and 7-day point-prevalence nicotine vaping abstinence at Week 12 compared to other groups 3. Other trials involving varenicline also reported bioverified point-prevalence abstinence at both 14 weeks and 27 weeks 6, while one study noted a significantly higher number of participants achieving initial cessation in the first 7 days post-quit 2.

Nicotine replacement therapies (NRT) show varying results across different formulations. A combination of long-term nicotine patch and nicotine gum showed significant improvements in both self-reported 7-day point-prevalence abstinence and latency to relapse 18. Conversely, other studies on transdermal patches did not find statistically significant differences in 7-day point prevalence 7 or in the percentage change of cigarettes smoked per day 17. One study noted a difference in point prevalence abstinence at week 24 between two groups 15.

Bupropion was associated with reductions in ADHD rating scale scores and days of cigarette/cannabis use 10. When combined with behavioral intervention, bupropion significantly reduced Hamilton Depression Scale scores 13. Additionally, Bupropion SR showed significant changes in log brain-wave (EEG) activity and improvements in smoking withdrawal scores related to mood and depressive symptoms during a 66-day abstinence period 20.

Recent results — preliminary, needs further review

  • [] NJOY ACE e-cigarette (not yet corroborated).

For the clinician treating this condition

  • Varenicline is associated with statistically significant improvements in both short-term (4-week) and long-term (up to 27 weeks) nicotine vaping abstinence [3, 6].
  • Combination NRT (patch + gum) showed statistically significant improvements in self-reported abstinence and latency to relapse compared to other groups 18.
  • Bupropion may be utilized for patients with co-occurring symptoms, as it was associated with lower ADHD scores 10 and significantly lower depression scores when paired with behavioral interventions 13.

AI synthesis of 10 cited trials, updated Jun 22, 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.
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