Nicotine DependenceNCT00289653
Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation
A study testing Nicoderm in people with Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Nicoderm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 19 years of age
- male or female
- have intention to quit smoking within the next 6 months
- smoke 10 or more cigarettes per day
Who cannot join
- Pregnant or not using an adequate enough method of birth control to ensure that they are not at risk of becoming pregnant
- breastfeeding
- have any generalized skin disorders
- are in an immediate post-myocardial infarction period or have life-threatening arrhythmias, have severe or worsening angina pectoris or have had a recent cerebral vascular accident
- are using additional nicotine replacement therapies or any other smoking cessation pharmacotherapy
- any clinically significant ECG abnormalities
- any known hypersensitivity to components of the transdermal system
Trial locations and contacts
1 site in 1 country.
About this study
Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes.
Read the detailed description
Subjects who smoke while on an individually dosed tNRT will reduce their expired carbon monoxide levels from pre- to post-treatment conditions. They will also decrease their daily consumption of cigarettes.
- Conditions
- Nicotine Dependence
- Being tested
- Nicoderm
- Keywords
- nicotine dependence,, transdermal nicotine patch,, smoking while receiving nicotine replacement,, comorbidities
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicodermDrug
Also called NRT patch, nicotine patch
| Study group | Role | What they receive |
|---|---|---|
| single open-label treatment arm | Experimental | Adult smokers willing to quit were treated with escalating doses of transdermal nicotine patch (Nicoderm) and brief counselling if they continued to smoke over a 9-week treatment period. Receives: Drug: Nicoderm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon Monoxide Levels
Expired Co levels were measured to confirm smoking status
Measured: measured at week 10
Secondary outcomes (1)
Smoking Cessation
self reported # cigarettes per day
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startSep 2005
- Primary completionDec 2006
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter Selby, Centre for Addiction and Mental Health
- Investigators
- Peter L. Selby, MBBS, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289653
- Sponsor's protocol ID
- 205/2005
- Status last verified
- Dec 2017
- First submitted
- 8 Feb 2006
- Last updated
- 5 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Selby P, Andriash K, Zawertailo L, Persad D, Zack M, Busto UE. Escalating doses of transdermal nicotine in heavy smokers: effects on smoking behavior and craving. J Clin Psychopharmacol. 2013 Oct;33(5):667-74. doi: 10.1097/JCP.0b013e31829a829d.
PubMed 23963055
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation
- ClinicalTrials.gov ID
- NCT00289653
- Acronym / sponsor ID
- 205/2005
- Conditions
- Nicotine Dependence
- Keywords
- nicotine dependence,, transdermal nicotine patch,, smoking while receiving nicotine replacement,, comorbidities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Sep 2005 (actual)
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 10 Feb 2006 (estimated)
- Results
- Posted 5 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes.
Detailed description
Subjects who smoke while on an individually dosed tNRT will reduce their expired carbon monoxide levels from pre- to post-treatment conditions. They will also decrease their daily consumption of cigarettes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single open-label treatment arm | Experimental | Drug: NicodermAdult smokers willing to quit were treated with escalating doses of transdermal nicotine patch (Nicoderm) and brief counselling if they continued to smoke over a 9-week treatment period. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 19 years of age
- male or female
- have intention to quit smoking within the next 6 months
- smoke 10 or more cigarettes per day
Key exclusion criteria (7 listed)
- Pregnant or not using an adequate enough method of birth control to ensure that they are not at risk of becoming pregnant
- breastfeeding
- have any generalized skin disorders
- are in an immediate post-myocardial infarction period or have life-threatening arrhythmias, have severe or worsening angina pectoris or have had a recent cerebral vascular accident
- are using additional nicotine replacement therapies or any other smoking cessation pharmacotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicodermAlso: NRT patch, nicotine patch | Drug | single open-label treatment arm |
Primary outcome
Carbon Monoxide Levels
Time frame: measured at week 10
Expired Co levels were measured to confirm smoking status
1 secondary outcome
Smoking Cessation
Time frame: Week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23963055Selby P, Andriash K, Zawertailo L, Persad D, Zack M, Busto UE. Escalating doses of transdermal nicotine in heavy smokers: effects on smoking behavior and craving. J Clin Psychopharmacol. 2013 Oct;33(5):667-74. doi: 10.1097/JCP.0b013e31829a829d.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter L. Selby, MBBS principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicoderm in people with 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 7 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 5 Oct 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Carbon Monoxide Levels (time frame: measured at week 10). 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 NCT00289653, which also lists 1 linked publication.
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 5 Oct 2018.