Phase 3
N=4,200
Telephone Counseling and the Distribution of Nicotine Patches to Smokers
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT00851357 ↗Enrolled (actual)
4,200
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Number of Participants With Six-month Continuous Abstinence From Cigarettes — 70; 101; 190 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nicotine Patch (Drug); Telephone Counseling (Behavioral); Placebo (Drug); Self-Help Materials (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Six-month Continuous Abstinence From Cigarettes |
70; 101; 190 | — |
| SECONDARY Number of Participants Quit for 30-days at 2-months Post Enrollment |
136; 173; 334 | — |
Summary
The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to:
1. Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans).
2. Test if sending placebo patches directly will also lead to a higher quit rate.
3. Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.
Eligibility Criteria
Inclusion Criteria
- >= 18 years old
- Daily smoker
- >=6 cigarettes per day
- Ready to quit within one month
- First time quitline caller
- Valid phone number
- Valid address (no P.O. boxes)
- California resident
- Agree to participate in study and evaluation
- English or Spanish speaking
Exclusion Criteria
- Uses other form of tobacco
- Use of Zyban or Chantix
- One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina, Heart attack within last year, Stroke within last year, Uncontrolled high blood pressure, Insulin-dependent diabetes, Pregnancy
Data sourced from ClinicalTrials.gov (NCT00851357). 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.