Phase 3
Completed N=3,706
Providing Free Nicotine Patches to Quitline Smokers
Source: ClinicalTrials.gov NCT01736085 ↗Enrolled (actual)
3,706
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Number of Participants With Six Months Prolonged Abstinence — 61; 76; 151 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 This can indicate results are unpublished — a known publication-bias signal.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 California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling condition) randomized trial to test the provision of nicotine patches to help smokers calling a telephone quitline. The study assesses one factor related to nicotine patches with 3 levels: sending patches directly from the Helpline, providing vouchers that can be redeemed for patches, and usual care. A second factor is counseling plus materials versus materials only. This proposed study has the following specific aims:
1. To demonstrate that a voucher for free nicotine patches will increase the quit rate for smokers who do not have access to free nicotine replacement therapy (NRT)
2. To demonstrate that sending patches directly from a quitline would outperform sending vouchers for free NRT, since the vouchers impose an additional barrier to those who want to quit
3. To determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Six Months Prolonged Abstinence |
61; 76; 151 | — |
| SECONDARY Percentage of Smokers Making a 24-hour Quit Attempt |
455; 533; 879 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- Current smoker
- First time quitline caller
- Not eligible for nicotine patches through other programs such as MediCal or Los Angeles County which provides free nicotine patches
- English and/or Spanish speaking
- Valid phone number
- Valid address
- CA resident
- Gave consent to participate in study and evaluation
Exclusion Criteria
- Contraindication(s) to nicotine patches
- Uses a form of tobacco other than cigarettes
- Plans to use Chantix
Data sourced from ClinicalTrials.gov (NCT01736085). 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.