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Tobacco Use DisorderPhase 2/3iT-NRTNCT02439944

Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement

A Phase 2/3 study testing Nicotine patch and Nicotine mouthspray in people with Tobacco Use Disorder and Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study involves the use of personalized nicotine patch dosing as a treatment strategy for smokers who cannot quit smoking after 2 weeks of using the standard nicotine patch dose. Functional Magnetic Resonance Imaging scans will also be obtained from all study participants before and after treatment. Read more about this study

Who is it for?
Ages 19 to 65 years
Conditions the study is for
Tobacco Use Disorder, Nicotine Dependence
What is being tested?
Nicotine patch and Nicotine mouthspray
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteCanada
Study dates
Jul 2015to Dec 2017
Phase
Phase 2/3
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 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Daily tobacco smoker of
  • Aged 19 to 65 years old
  • Intending to quit smoking within the next 30 days
  • Interested in using transdermal nicotine replacement therapy (nicotine patch)

Who cannot join

  • At least weekly use of tobacco products other than cigarettes
  • Breast feeding, pregnancy or not using a reliable form of birth control
  • Any generalized skin disorders precluding the use of the patch
  • Immediate post-myocardial infarction period or life-threatening arrhythmias, severe or worsening angina pectoris or recent cerebral vascular accident
  • Any clinically significant electrocardiogram (ECG) abnormalities
  • Currently using NRT or other smoking cessation pharmacotherapy
Show all 9Show fewer
  • Any known hypersensitivity or allergies to any of the components comprising the nicotine patch
  • MRI contraindications (e.g., metal in body, claustrophobia) as per the CAMH RIC screening questionnaire
  • Diagnosis of terminal illness.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Addiction and Mental Health, Nicotine Dependence Clinic

    Toronto, Ontario, M5T 1P7

Other trials in Canada

About this study

Official title: Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement: A Randomized, Controlled Pilot Study in Motivated Smokers Unable to Quit With Standard Dosing

This study involves the use of personalized nicotine patch dosing as a treatment strategy for smokers who cannot quit smoking after 2 weeks of using the standard nicotine patch dose. Functional Magnetic Resonance Imaging scans will also be obtained from all study participants before and after treatment. The first aim of the study is to determine if the treatment method under investigation is safe and more effective at increasing quit rates in smokers who do not respond to standard therapy.The second aim is to determine if there are any treatment- or cessation-related changes in brain function.

Read the detailed description

Nicotine Replacement Therapy (NRT) is limited in efficacy. One possible explanation for this limited efficacy is that the nicotine dose received in standard therapy is not enough to replace the amount of nicotine that smokers typically receive from their cigarettes. In an effort to counteract this problem, this study will increase the nicotine patch dose of smokers until they no longer feel the need to keep smoking or they cannot tolerate a higher nicotine dose. Smokers who cannot quit using 21 mg nicotine patch for 2 weeks will be randomized to either the experimental arm of the study where nicotine patch doses will be adjusted according to individual need or the positive control arm where standard NRT smoking cessation therapy will be employed. The primary outcome measure will be continuous abstinence during the last 4 weeks of treatment. In addition, participants will be assessed to see how treatment has impacted their resting state neural activity as well as their responsiveness to smoking and emotional cues. Follow up sessions will be used to assess long term abstinence as well as long term change in neural activation.

Being tested
Nicotine patch, Nicotine mouthspray
Keywords
Nicotine Patch, Nicotine Mouth Spray, Smoking Cessation, Quit Smoking, Abstinence, Dependence, Nicotine, Tobacco, Transdermal Nicotine Replacement Therapy, Functional Magnetic Resonance Imaging, Neuroimaging, Cue Reactivity, Resting State, BOLD fMRI
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

  • Nicotine mouthsprayDrug

    Also called Nicorette Quickmist

Study groups in NCT02439944
Study groupRoleWhat they receive
Experimental ArmExperimentalEscalating nicotine patch dose to satiety over 6 weeks with dosage depending on the number of cigarettes smoked per day and the occurrence of adverse effects
Receives: Drug: Nicotine patch
Positive Control ArmActive comparatorNicotine patch dose of 21mg coupled with nicotine mouthspray which is to be used as needed.
Receives: Drug: Nicotine patch; Drug: Nicotine mouthspray

What is being measured

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

  1. 4 weeks continuous smoking abstinence

    4 weeks of abstinence without a single puff of a cigarette confirmed by self-report and exhaled carbon monoxide (CO less than or equal to 4ppm)

    Measured: Treatment weeks 9-12 inclusive

Secondary outcomes (1)

  1. Cue induced brain activation

    Brain activation in response to viewing emotional and smoking cues as measured by fMRI

    Measured: up to 6 month follow-up

Timeline

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

  1. First posted12 May 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionDec 2017
  4. Study completionDec 2017

Why it stopped: full RCT funded. no need to continue pilot data collection.

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02439944
Sponsor's protocol ID
095/2014
Acronym
iT-NRT
Status last verified
Jul 2018
First submitted
7 May 2015
Last updated
19 Jul 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nicotine patch and Nicotine mouthspray in people with Tobacco Use Disorder and Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site 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 9 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: stopped early, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: full RCT funded. no need to continue pilot data collection.). Results are not available in the source record.

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?

4 weeks continuous smoking abstinence (time frame: Treatment weeks 9-12 inclusive). 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 NCT02439944.

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 19 Jul 2018.

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