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Smoking CessationPhase 4RWNCT01623505

Reducing Cardiovascular Disease by Combining Smoking Cessation Pharmacotherapy and Behavioural Counseling

A Phase 4 study testing Champix, Transdermal Nicoderm patch combined with gum or inhaler and Transdermal Nicoderm patch in people with Smoking Cessation and Psychiatric Illness, run by Ottawa Heart Institute Research Corporation at 1 site 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

Research Aims The aims of this research study are: 1. To determine which of the following three smoking cessation medications is most effective in achieving cessation: Nicotine Patch Nicotine Patch + gum or inhaler Varenicline (Champix; 2. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation, Psychiatric Illness
What is being tested?
Champix, Transdermal Nicoderm patch combined with gum or inhaler and Transdermal Nicoderm patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
738 participants
Where
1 siteCanada
Study dates
Jun 2010to Jun 2014
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant is a current smoker (≥ 10 cigarettes per day in the preceding\ six months);
  • Participant is willing to make a quit attempt in the 2-4 weeks after initial screening for eligibility;
  • Participant is 18 years of age and older;
  • Participant is willing to provide informed consent.

Who cannot join

  • Participant is currently using or has used any intervention medications in the previous 6 months (i.e, Champix (varenicline); and/or Nicotine replacement therapy (patch, gum, inhaler, lozenge));
  • Participant has contraindication(s) to any of the following smoking cessation medications:
  • Nicotine replacement therapy (allergic reaction to adhesive; serious cardiac arrhythmias (e.g., tachycardia); participant is during the immediate post-myocardial infarction period (i.e. incident has occurred within the last 10 days); severe or worsening angina pectoris; participant has had a recent cerebral vascular accident);
  • Varenicline (end-stage renal disease; use of cimetidine (by participants with severe renal impairment); previous allergic reaction to varenicline);
  • Pregnant or breastfeeding women or those intending to become pregnant in the next year;
  • Current or previous (in the last 3 months) substance abuse;
Show all 9Show fewer
  • Unable to provide informed consent due to unstable psychiatric symptoms (e.g., active, untreated psychosis or suicidality);
  • Participant is unable to read and understand English or French;
  • In order to prevent contamination across groups, only one person per household may participate.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Ottawa Heart Insitute - Prevention and Wellness Centre

    Ottawa, Ontario, K1Y 4W7

Other trials in Canada

About this study

Official title: Interventions for Cardiovascular Disease: "Real-World" Effectiveness of Combined Pharmacotherapy and Behavioural Counseling for Smoking Cessation

Research Aims

The aims of this research study are:

Read more
  1. To determine which of the following three smoking cessation medications is most effective in achieving cessation:
  • Nicotine Patch
  • Nicotine Patch + gum or inhaler
  • Varenicline (Champix;
  1. To investigate how often participants experience neuropsychiatric symptoms over the course of their cessation attempt and to assess whether:
  • They occur more often when taking one medication versus another
  • They occur more often in those with or without psychiatric illnesses.

Hypotheses to be Tested

The hypotheses to be tested include the following:

  1. The CO-confirmed continuous abstinence rate from 5 weeks to 52 weeks following a target quit date will be significantly higher in smokers receiving long-term transdermal NRT in combination with other NRT products or those receiving varenicline compared to those receiving transdermal NRT alone.
  2. Some participants will experience neuropsychiatric symptoms during their cessation attempt, and those in the varenicline group will experience a greater incidence of neuropsychiatric symptoms than those in the groups receiving transdermal NRT alone or in combination with other NRT products. Patients with psychiatric illnesses will report higher levels of withdrawal symptoms than those without psychiatric illnesses.
Read the detailed description

Participants will be recruited from the UOHI Smoking Cessation Clinic and via media advertisements. Following the baseline assessment, participants will be randomly assigned to one of three groups:

  1. 10-week standard regimen of transdermal NRT (NRT);
  2. Long duration of transdermal NRT in combination with other NRT products (NRT+); or
  3. Varenicline (VR).

Participants assigned to the "NRT" standard regimen group will follow a 10-week treatment of nicotine patches alone.

Participants assigned to the "NRT+" long-duration group will follow the same regimen as the NRT group, but will not be limited to a fixed declining dose strategy, nor limited to a 10-week duration (potential maximum dosage of 35mg/day and maximum treatment duration of up to 22 weeks). Participants will also be provided with other NRT products (i.e., gum or inhaler).

Participants assigned to the "VR" group will start the medication on the day of the baseline assessment and set a target quit date any time within the 8 to 14 day period after baseline. Participants will receive a 12-week supply of varenicline with a possible extension of up to 24 weeks.

All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation in accordance with nursing best-practice guidelines. These sessions occur at 1, 3, 5, 8, and 10 weeks post target quit date. Counselling sessions will focus on practical counselling (problem solving and skills training) and social support.

During the treatment phase, participants will complete questionnaires measuring withdrawal and neuropsychiatric symptoms at 1, 3, 5, 8, and 10 weeks. These questionnaires will also be completed at 22 and 52 weeks after the target quit date.

Being tested
Champix, Transdermal Nicoderm patch combined with gum or inhaler, Transdermal Nicoderm patch
Keywords
Smoking Cessation, Psychiatric Illness, Pharmacotherapy
Medical subject headings
Smoking Cessation, Mental Disorders

What participants receive

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

  • ChampixDrug

    Also called Chantix

    Participants receiving this treatment will start the medication on the day of the baseline assessment and set a target quit date within the 8 to 14 day period after baseline. Participants in this group will receive a 12-week supply of varenicline. Treatment will begin 2 weeks before the target quit date and continue for 10 weeks after the target quit date. Participants will be prescribed 0.5 mg once daily for 3 days, 0.5 mg twice daily for 4 days, and 1 mg twice daily for 11 weeks. Participants will be given the option of extending their treatment to a maximum of up to 24 weeks of varenicline.

    All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation.

  • Transdermal Nicoderm patch combined with gum or inhalerDrug

    Also called Habitrol

    Participants receiving this treatment will set a quit date within 2 weeks after baseline assessment and apply the patch on that day. This group will follow the same regimen as the "standard patch treatment", but is not limited to a fixed dosing strategy. Participants will be advised on the titration of patch (increase or decrease in dosage) to ensure elimination of withdrawal symptoms (maximum dosage of 35mg/day, maximum treatment of up to 22 weeks). Participants will be provided with either gum or inhaler to manage cravings.

    All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation.

    *Off-label dosage approved by Health Canada via "No Objection" letter.

  • Transdermal Nicoderm patchDrug

    Also called Habitrol

    Participants receiving this treatment group (standard treatment)will set a target quit date within the 2 weeks after baseline assessment and start to apply the patch on that day. This treatment will consist of a 10-week supply of nicotine patches. The initial dosage will be determined from the average number of cigarettes smoked each day as per the manufacturer's recommendation. Participants smoking ≥ 20 cigarettes per day will be prescribed 21 mg/24 hours for 6 weeks, 14 mg/24 hours for 2 weeks, and 7 mg/24 hours for 2 weeks. Participants smoking 11 - 20 cigarettes per day will be prescribed 14 mg/24 hours for 6 weeks, and 7 mg/24 hours for 4 weeks.

    All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation.

Study groups in NCT01623505
Study groupRoleWhat they receive
ChampixExperimentalNot described
Receives: Drug: Champix
Long & Combination patch treatmentExperimentalNot described
Receives: Drug: Transdermal Nicoderm patch combined with gum or inhaler
Standard patch treatmentExperimentalNot described
Receives: Drug: Transdermal Nicoderm patch

What is being measured

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

  1. The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks.

    Measured: 5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date

Secondary outcomes (1)

  1. The secondary outcome will include withdrawal and neuropsychiatric symptoms (e.g., depression, anxiety, suicidal ideation, anger/aggression). These variables will be measured at 1, 3, 5, 8, 10, 22, and 52 weeks following the target quit date.

    Measured: 1, 3, 5, 8, 10, 22, and 52 weeks post target quit date

Timeline

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

  1. First posted20 Jun 2012 (estimated)
  2. Study startJun 2010
  3. Primary completionJun 2014
  4. Study completionJun 2014

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
738 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01623505
Sponsor's protocol ID
HIPRC-6614
Acronym
RW
Status last verified
Apr 2017
First submitted
13 Jul 2011
Last updated
13 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.

    PubMed 18263663

  • Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55. doi: 10.1001/jama.296.1.47.

    PubMed 16820546

  • Hughes JR, Keely J, Naud S. Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2004 Jan;99(1):29-38. doi: 10.1111/j.1360-0443.2004.00540.x.

    PubMed 14678060

  • Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.

    PubMed 18617085

  • Stapleton JA, Watson L, Spirling LI, Smith R, Milbrandt A, Ratcliffe M, Sutherland G. Varenicline in the routine treatment of tobacco dependence: a pre-post comparison with nicotine replacement therapy and an evaluation in those with mental illness. Addiction. 2008 Jan;103(1):146-54. doi: 10.1111/j.1360-0443.2007.02083.x. Epub 2007 Nov 19.

    PubMed 18028247

  • Lasser K, Boyd JW, Woolhandler S, Himmelstein DU, McCormick D, Bor DH. Smoking and mental illness: A population-based prevalence study. JAMA. 2000 Nov 22-29;284(20):2606-10. doi: 10.1001/jama.284.20.2606.

    PubMed 11086367

  • Warner KE, Burns DM. Hardening and the hard-core smoker: concepts, evidence, and implications. Nicotine Tob Res. 2003 Feb;5(1):37-48. doi: 10.1080/1462220021000060428.

    PubMed 12745505

  • Grant BF, Hasin DS, Chou SP, Stinson FS, Dawson DA. Nicotine dependence and psychiatric disorders in the United States: results from the national epidemiologic survey on alcohol and related conditions. Arch Gen Psychiatry. 2004 Nov;61(11):1107-15. doi: 10.1001/archpsyc.61.11.1107.

    PubMed 15520358

  • Slovinec D'Angelo ME, Reid RD, Hotz S, Irvine J, Segal RJ, Blanchard CM, Pipe A. Is stress management training a useful addition to physician advice and nicotine replacement therapy during smoking cessation in women? Results of a randomized trial. Am J Health Promot. 2005 Nov-Dec;20(2):127-34. doi: 10.4278/0890-1171-20.2.127.

    PubMed 16295704

  • 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

  • Tulloch HE, Pipe AL, Els C, Clyde MJ, Reid RD. Flexible, dual-form nicotine replacement therapy or varenicline in comparison with nicotine patch for smoking cessation: a randomized controlled trial. BMC Med. 2016 Jun 7;14:80. doi: 10.1186/s12916-016-0626-2.

    PubMed 27233840

  • Tulloch HE, Pipe AL, Clyde MJ, Reid RD, Els C. The Quit Experience and Concerns of Smokers With Psychiatric Illness. Am J Prev Med. 2016 Jun;50(6):709-718. doi: 10.1016/j.amepre.2015.11.006. Epub 2015 Dec 17.

    PubMed 26711162

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Champix, Transdermal Nicoderm patch combined with gum or inhaler and Transdermal Nicoderm patch in people with Smoking Cessation and Psychiatric Illness, run by Ottawa Heart Institute Research Corporation 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: finished, as of the sponsor's last update on 13 Apr 2017. 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 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?

The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (time frame: 5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date). 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 NCT01623505, which also lists 12 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 13 Apr 2017.

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