Phase 3
N=74
Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03060083 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Feasibility as Indicated by Self-reported Adherence to Study Cigarettes. — 7.1; 7.3; 10.4; 13.3 Percent non-study cigarettes per day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT) (Other); Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Indicated by Self-reported Adherence to Study Cigarettes. |
7.1; 7.3; 10.4; 13.3; 14.8; 31.2 | — |
| PRIMARY Self Reported Dependence Using the Nicotine Dependence Syndrome Scale (NDSS) |
-0.7; -0.8; -1.1; -1.0; -1.2; -1.2 | — |
| SECONDARY Any Quit Attempt (QA) |
6; 13 | — |
| SECONDARY Number of Participants With Self Reported Seven Day Point Prevalence Abstinence |
0; 1 | — |
| SECONDARY Self-efficacy to Quit Smoking |
2.5; 2.9; 2.6; 2.7; 2.7; 2.8 | — |
Summary
The FDA recently gained the authority to regulate the nicotine content of cigarettes. Prior research suggests that smokers who switch to very low nicotine content (VLNC) cigarettes experience reduced addiction to nicotine and are more likely to quit smoking. Currently, the most common method for smokers to reduce their nicotine intake is to reduce their number of cigarettes per day (CPD). No research has compared reducing smokers' nicotine intake by switching to VLNC cigarettes vs by reducing CPD with regard to decreasing dependence or quitting; thus the investigators will examine the two strategies by randomizing smokers to 1) switch to VLNC cigarettes or 2) reduce CPD. In addition, all smokers will use the nicotine patch to help them reduce their nicotine intake.
Eligibility Criteria
Eligibility will be determined based on:
- participants' age,
- their cigarettes smoked per day,
- their intention to quit,
- their willingness to use medications,
- prior use of tobacco and non-tobacco nicotine products,
- prior use of stop-smoking services or medications,
- DSM 5 criteria for Tobacco Use Disorder,
- current use of opioid maintenance medications,
- access to a telephone and the Internet,
- proximity to the University of Vermont,
- their bed time,
- status as a US citizen,
- comfort speaking, reading and writing in English, and
- whether or not the participant is breast feeding, pregnant or has the potential to become pregnant or begin breastfeeding during the study period.
Data sourced from ClinicalTrials.gov (NCT03060083). 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.