Phase 4
N=544
Evaluation of Treatments to Improve Smoking Cessation Medication Adherence
Smoking · Smoking Cessation · Adherence · Nicotine Dependence · Motivation
Bottom Line
View on ClinicalTrials.gov: NCT01120704 ↗Enrolled (actual)
544
Serious AEs
2.9%
Results posted
Feb 2015
Primary outcome: Primary: Self-Reported 7-Day Point-Prevalence Abstinence — 197; 181; 202; 176 participants — p=.011
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Short Term Combination Nicotine Replacement Therapy (patch + gum) (Drug); Long Term Combination Nicotine Replacement Therapy (patch + gum) (Drug); Intensive Maintenance Counseling (Behavioral); Cognitive Medication Adherence Counseling (CAM) (Behavioral); Electronic Medication Monitoring Device (the Helping Hand) + Feedback (Behavioral); Automated Adherence Prompting Phone Calls (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Reported 7-Day Point-Prevalence Abstinence |
197; 181; 202; 176; 184; 194 | .011 sig |
| SECONDARY Latency to Relapse |
227; 209; 228; 208; 214; 222 | .045 sig |
Summary
Many smokers fail to take their smoking cessation medication as recommended. This research is designed to identify treatments that improve the use of cessation medications and to determine whether an increase in medication use results in increased cessation success. This research will also identify treatments that help people stay quit after a quit attempt and will pioneer more efficient research methods.
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 (NCT01120704). 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.