Phase 4
Completed N=637
Identifying Optimal Smoking Cessation Intervention Components (Cessation)
Source: ClinicalTrials.gov NCT01116986 ↗Enrolled (actual)
637
Serious AEs
0.7%
Results posted
Mar 2015
Primary outcomePrimary: Self-Reported 7-Day Point-Prevalence Abstinence — 208; 209; 201; 216 participants — p=.341
Summary
The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. The investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Reported 7-Day Point-Prevalence Abstinence |
208; 209; 201; 216; 221; 196 | .341 |
| SECONDARY Latency to Relapse |
235; 243; 228; 250; 243; 235 | .312 |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older;
- Report smoking at least 5 cigarettes per day for the previous 6 months;
- Able to read and write English;
- Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts;
- Plans to remain in the intervention catchment area for at least 12 months;
- Currently interested in quitting smoking (defined as would like to try to quit in the next 30 days).
- All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study.
Exclusion Criteria
- Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study);
- Study candidate is pregnant, trying to get pregnant, or nursing.
- A history of psychosis or bipolar disorder
- A history of skin or allergic reactions while using a nicotine patch.
- Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.
Data sourced from ClinicalTrials.gov (NCT01116986). 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.