Smoking Cessation Clinical Trial
— RWOfficial title:
Interventions for Cardiovascular Disease: "Real-World" Effectiveness of Combined Pharmacotherapy and Behavioural Counseling for Smoking Cessation
Verified date | April 2017 |
Source | Ottawa Heart Institute Research Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. 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.
Status | Completed |
Enrollment | 738 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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; - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa Heart Insitute - Prevention and Wellness Centre | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Heart Institute Research Corporation | Heart and Stroke Foundation of Ontario |
Canada,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2007 Nov 19. — View Citation
Warner KE, Burns DM. Hardening and the hard-core smoker: concepts, evidence, and implications. Nicotine Tob Res. 2003 Feb;5(1):37-48. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date | ||
Secondary | 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. | 1, 3, 5, 8, 10, 22, and 52 weeks post target quit date |
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