Personalized Dosing of Nicotine Replacement (NRT to Effect)
Condition: Tobacco Use Disorder; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Medications for smoking cessation are currently only effective in helping a minority of
      smokers quit. Drug development is slow and expensive, so there is much interest in optimizing
      the effectiveness of existing treatments and medications. Current standard doses of nicotine
      replacement therapy (NRT) are not effective for many smokers and in many cases provide less
      nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed
      study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting
      success in those who do not respond to a standard dose of NRT (21mg).
    

Detailed description: 
      A total of 500 smokers will be enrolled from two smoking cessation clinics to participate in
      this study. After 2 weeks of usual treatment with 21mg patch, participants who fail to quit
      smoking will be randomized to receive either escalating doses of active nicotine patches, or
      placebo patches, for 10 weeks. Those who stop smoking during the first 2 weeks of usual
      treatment will continue with 21mg patch treatment for 10 weeks as an additional comparison
      group. In addition to the medication, participants in all groups will receive brief
      behavioral counselling. Subjects will return to the clinic at weeks 26 and 52 to assess
      whether or not they are still abstinent from smoking and self-reports of non-smoking will be
      confirmed using a urine test for nicotine by-product (cotinine) levels. Exhaled carbon
      monoxide (CO) will be recorded as an additional measure. Study follow-up visits can be
      conducted virtually if needed.

      The goal of the proposed study is to optimize the current gold standard smoking cessation
      treatment (nicotine patch plus brief counseling) in order to further increase quit rates.
      Evidence supporting the effectiveness of personalized doses of NRT could change current
      practice in a wide variety of healthcare settings. Given the strong link between smoking and
      cancer, and evidence that quitting smoking at any age diminishes this risk, even small
      increases in absolute quit rates can have a substantial population-level impact on reducing
      the incidence of smoking-related cancers, reducing mortality rates and associated healthcare
      costs.
    

Intervention name(s): Nicotine Patch; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Active nicotine patch of 21 mg, 14 mg and 7 mg; Matching placebo patches of 21 mg, 14 mg and 7 mg
Other intervention name(s): Nicoderm; Placebo patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nicotine Replacement Therapy; Smoking Cessation; Randomized Clinical Trial; Nicotine Patch; Abstinence; Placebo; Double blind