Phase 3
Completed N=4,200
Telephone Counseling and the Distribution of Nicotine Patches to Smokers
Source: ClinicalTrials.gov NCT00851357 ↗Enrolled (actual)
4,200
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Number of Participants With Six-month Continuous Abstinence From Cigarettes — 70; 101; 190 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.