Phase 3
Completed N=606
Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
Source: ClinicalTrials.gov NCT00894166 ↗Enrolled (actual)
606
Serious AEs
2.8%
Results posted
Dec 2012
Primary outcomePrimary: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) — 59.2; 28.3; 23.3; 16.0 percentage of subjects abstinent
Summary
Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit from prescription treatment alternatives, including Zyban or Chantix. In this study, the investigators propose to develop and evaluate a stepped-care treatment algorithm that would evaluate whether smokers who receive treatment with NRT should be supplemented with Zyban or switched to Chantix only based on: 1) their initial response to NRT; and 2) individual genetic factors found to predict smoking cessation in other studies evaluating these treatments. This study is a continuation of our previous studies showing that abstinence rates can be increased by starting nicotine patch therapy two weeks before the quit date. The investigators will provide pre-cessation NRT to all participants initially. Those who do not show a favorable response on early indicators of success (e.g., smoking in the first week after the target quit-smoking date) will receive "rescue" treatment by having their NRT treatment supplemented with Zyban , by being switched to treatment with Chantix or will remain on NRT (control).
The investigators hypothesize that "Rescue" treatment with Zyban in combination with NRT or Chantix will increase success rates over leaving subjects on NRT when they are NRT insufficient responders, i.e. they have shown an unfavorable response to NRT in the first week pre-quit or the first week post-quit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) |
59.2; 28.3; 23.3; 16.0; 26.7; 37.1 | — |
| SECONDARY Abstinence (7 Days) at 6 Months. |
21.7; 17.2; 16.5; 6.6; 10.0; 20.0 | — |
| SECONDARY Continuous Abstinence From Smoking at 6 Months Post Quit. |
20.0; 13.1; 5.8; 5.8; 10.0; 14.3 | — |
Eligibility Criteria
Inclusion Criteria
- 18-65 years old
- smoked an average of at least 10 cigarettes per day for three cumulative years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5mg nicotine
- expired carbon monoxide reading of at least 15ppm
- express a desire to quit smoking in the next 30 days
Exclusion Criteria
- Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
- Hypotension (systolic 9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
- Bulimia or anorexia;
- Pregnant or nursing mothers;
- Use (within the past 30 days) of:
- Illegal drugs (or if the urine drug screen is positive),
- Experimental (investigational) drugs;
- Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
- Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed)
- Smokeless tobacco (chewing tobacco, snuff), cigars or pipes;
- Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
- Alcohol abuse - The AUDIT (Alcohol Use Disorders Identification Test) questionnaire will be used to assess alcohol abuse. Potential participants will be asked the first two questions on the AUDIT questionnaire during the phone screen. If the person scores "4" on both questions, a screening appointment will not be scheduled. During the screening session the entire AUDIT questionnaire will be administered. Females who score greater than or equal to 13 and males who score greater than or equal to 15 will be excluded from the study.
- Significant adverse reaction to Wellbutrin / Zyban or Chantix / Varenicline in the past
Data sourced from ClinicalTrials.gov (NCT00894166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.