N/A
Completed N=369
Cessation in Non-Daily Smokers
Source: ClinicalTrials.gov NCT02168855 ↗Enrolled (actual)
369
Serious AEs
6.2%
Results posted
May 2020
Primary outcomePrimary: Smoking Cessation, Continuous 6-month Abstinence — 13; 10 Participants — p=0.46
Summary
The purpose of this study is to examine the effect of as-needed oral Nicotine Replacement Therapy (NRT) - 2 mg nicotine gum - for smoking cessation in non-daily, or intermittent, smokers, and to study the process of relapse in ITS, using Ecological Momentary Assessment (EMA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Cessation, Continuous 6-month Abstinence |
13; 10 | 0.46 |
| SECONDARY Characteristics of Quit and Relapse Process - Craving |
16.68; 57.09 | <0.0001 sig |
| SECONDARY Characteristics of Quit and Relapse Process - Negative Affect |
49.13; 51.96 | <0.0001 sig |
| SECONDARY Characteristics of Quit and Relapse Process - Saw No Smoking Cues |
83.64; 59.11 | <0.0001 sig |
| SECONDARY Characteristics of Quit and Relapse Process - No Others Smoking Nearby |
90.42; 66.82 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 18 years old or older
- Smoking for at least 3 years
- Smoking non-daily for at least one year (< or = 27 days/month)
- Smoke at least weekly
- Intention to quit smoking within the next month and a desire to receive behavioral and medication treatment
- Willing and able to come to the laboratory for 8 visits over a 14-week period, as well as a ninth and final visit 6 months after their quit date
- Willing to monitor behavior via an electronic diary for 8 weeks
- Able to read and write English (in order to understand questionnaires and study instructions)
Exclusion Criteria
- Regular use of any form of tobacco other than cigarettes
- Recent or severe mental illness (uncontrolled severe depression or mood symptoms, active hallucinations, and or hospitalization in the past month for a psychiatric condition)
- Night and/or 'swing' shift work (which complicates EMA schedules)
- Known plans to relocate or move from the Pittsburgh area within the coming 6 months
- Received cessation treatment within past year
- Use of bupropion or varenicline in past 2 months
- Past use of nicotine gum (to avoid un-blinding)
- Contraindication to NRT
- (for women) Current pregnancy or breastfeeding or plan to become pregnant during the next 2 months
- Member of the same household already participating
Data sourced from ClinicalTrials.gov (NCT02168855). 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.