A Phase 4 interventional study of Nicotine Patch and Placebos in Tobacco Use Disorder and Nicotine Dependence, sponsored by Centre for Addiction and Mental Health. Completed at 2 sites in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by Centre for Addiction and Mental Health · Phase 4, Interventional, and Treatment
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).
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 211 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Participants unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus additional active nicotine patches until achieving 7 consecutive days of abstinence over the next 5 weeks; maximum daily patch dose, 84mg/day
Drug: Nicotine Patch
Participant unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus placebo patches until 7 consecutive days of abstinence over the next 5 weeks; Maximum daily patch dose, 21mg active nicotine patch plus 3 placebo 21mg patches.
Drug: Nicotine Patch · Drug: Placebos
Participants able to quit for 7 consecutive days during the first 2 weeks of treatment with 21mg nicotine patch will continue open label 21mg active nicotine patches for the remaining 10 weeks.
Drug: Nicotine Patch
Active nicotine patch of 21 mg, 14 mg and 7 mg
Also known as: Nicoderm
Matching placebo patches of 21 mg, 14 mg and 7 mg
Also known as: Placebo patch
Short term continuous abstinence
YES, If self-reported 4 weeks of abstinence without a single puff of a cigarette or any other tobacco product. Else, NO.
Time frame: weeks 9 to 12
Long term continuous abstinence
YES, if self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO.
Time frame: weeks 9-26
Long term continuous abstinence
YES, if, self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO.
Time frame: weeks 9-52
Plan to share: No
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Centre for Addiction and Mental Health