Phase 4
Completed N=701
Treatment of Smoking Lapses and Relapses
Source: ClinicalTrials.gov NCT01807871 ↗Enrolled (actual)
701
Serious AEs
1.1%
Results posted
Mar 2017
Primary outcomePrimary: Point-prevalent Abstinence at 4 Months — 90; 59 Participants — p=0.48
◆ Published Evidence
Established
92citations · ~12 / year
Effectiveness of continuing nicotine replacement after a lapse: A randomized trial.
Summary
Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe to continue NM upon a lapse and that doing so dramatically increases success at quitting. The investigators will test this by doing a randomized trial in which all treatment and measures are done from home with paper, phone or computer surveys. The investigators will recruit smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and 5 weeks of counseling. One group will be asked to stop use of the patch if they lapse and the other group will be asked to continue use of the patch if they lapse. The investigators will compare the groups on their success at quitting and side-effects.
Linked Publications (2)
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Effectiveness of continuing nicotine replacement after a lapse: A randomized trial.
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Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Point-prevalent Abstinence at 4 Months |
90; 59 | 0.48 |
| SECONDARY Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence |
— | — |
| SECONDARY Adverse Drug Effects |
37; 27 | 0.24 |
Eligibility Criteria
Inclusion Criteria
- at least 18 years old
- daily smoker of 10 or more cigarettes per day for at least 1 year
- state they plan to probably or definitely quit smoking in the next month
- have a home or cell phone
- willing to use nicotine patch
- good command of written and spoken English
- weigh at least 100 pounds
- US citizen or permanent resident alien
Exclusion Criteria
- use of non-cigarette tobacco in the last month
- use of a smoking cessation medication or smoking cessation counseling in the last month
- medical contraindication to use of patch
- other person in household already in our study
- previously a participant in the study
- currently pregnant or breast feeding
- plan to become pregnant in the next 6 months
- regularly works the overnight shift
- use of electronic cigarettes in the last month
Data sourced from ClinicalTrials.gov (NCT01807871) and the linked publication. 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.