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Tobacco Use DisorderPhase 4NCT03000387

Personalized Dosing of Nicotine Replacement (NRT to Effect)

A Phase 4 study testing Nicotine Patch in people with Tobacco Use Disorder and Nicotine Dependence, run by Centre for Addiction and Mental Health at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Tobacco Use Disorder, Nicotine Dependence
What is being tested?
Nicotine Patch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
211 participants
Where
2 sitesCanada
Study dates
23 Jan 2018to 11 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Daily tobacco smoker of ≥10 cigarettes per day
  • Aged 18 to 75 years old
  • Interested in using tNRT as the only smoking cessation aid
  • Intending to quit smoking within the next 30 days

Who cannot join

  • At least weekly use of tobacco products other than cigarettes and not willing to stop for the duration of the study
  • Breast feeding, pregnancy or not using a reliable form of birth control
  • Any generalized skin disorders precluding the use of the patch
  • Any life threatening arrhythmias or severe/worsening angina pectoris or within two weeks of experiencing a myocardial infarction or cerebral vascular accident
  • Currently using or has used NRT or other smoking cessation pharmacotherapy within the past two weeks
  • Any known hypersensitivity or allergies to any of the components comprising the nicotine patch
Show all 10Show fewer
  • Current active substance dependence (excluding caffeine) which would compromise study compliance
  • Current unstable psychiatric condition which would compromise study compliance
  • Diagnosis of terminal illness
  • Current regular use of e-cigarettes or other vaping devices containing nicotine and not willing to stop for the duration of the study

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J 1H4

Other trials in Canada

About this study

Official title: Personalized Dosing of Nicotine Replacement for Smoking Cessation: An Effectiveness Randomized Placebo-controlled Trial

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).

Read the 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.

Being tested
Nicotine Patch, Placebos
Keywords
Nicotine Replacement Therapy, Smoking Cessation, Randomized Clinical Trial, Nicotine Patch, Abstinence, Placebo, Double blind
Medical subject headings
Tobacco Use Disorder, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotine PatchDrug

    Also called Nicoderm

    Active nicotine patch of 21 mg, 14 mg and 7 mg

  • PlacebosDrug

    Also called Placebo patch

    Matching placebo patches of 21 mg, 14 mg and 7 mg

Study groups in NCT03000387
Study groupRoleWhat they receive
Experimental ConditionExperimentalParticipants 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
Receives: Drug: Nicotine Patch
Placebo ConditionPlacebo comparatorParticipant 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.
Receives: Drug: Nicotine Patch; Drug: Placebos
Quit conditionActive comparatorParticipants 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.
Receives: Drug: Nicotine Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: weeks 9 to 12

Secondary outcomes (2)

  1. Long term continuous abstinence

    YES, if self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO.

    Measured: weeks 9-26

  2. Long term continuous abstinence

    YES, if, self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO.

    Measured: weeks 9-52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2016 (estimated)
  2. Study start23 Jan 2018
  3. Primary completion27 Feb 2023
  4. Study completion11 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03000387
Sponsor's protocol ID
039/2015
Status last verified
Jan 2024
First submitted
17 Nov 2016
Last updated
29 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2.

    PubMed 37335995

  • Zawertailo L, Hendershot CS, Tyndale RF, Le Foll B, Samokhvalov AV, Thorpe KE, Pipe A, Reid RD, Selby P. Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial. Trials. 2020 Jun 29;21(1):592. doi: 10.1186/s13063-020-04532-7.

    PubMed 32600406

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nicotine Patch in people with Tobacco Use Disorder and Nicotine Dependence, run by Centre for Addiction and Mental Health at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short term continuous abstinence (time frame: weeks 9 to 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03000387, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.

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