N/A
Completed N=245
Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
Source: ClinicalTrials.gov NCT01928719 ↗Enrolled (actual)
245
Serious AEs
9.0%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants Who Dropped Out of Study as a Measure of Adherence — 52; 19 Participants — p=<0.0001
Summary
The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Dropped Out of Study as a Measure of Adherence |
52; 19 | <0.0001 sig |
| SECONDARY Predictors of Participant Dropout |
52; 19; 20; 14; 15; 18 | <0.0001 sig |
| SECONDARY Cigarettes Per Day |
21.0; 25.1 | 0.0006 sig |
| SECONDARY Nicotine Exposure |
128.6; 265.3 | <.0001 sig |
| SECONDARY Smoke Exposure |
27.2; 31.2 | 0.0305 sig |
| SECONDARY Perceived Stress |
12.9; 11.1 | 0.0207 sig |
| SECONDARY Cortisol |
0.32; 0.48 | 0.4191 |
Eligibility Criteria
Inclusion Criteria
- Age 18-65
- Less than 16 years of education
- Able to understand, and sign consent
- Smoke >4 cigarettes/day for at least a year
- No quit attempt in prior 1 month and not planning to quit smoking within next 6 months
- Plan to live in local area for next 8 months
- Able to read and write in English
- Women not pregnant and taking steps to avoid pregnancy
Exclusion Criteria
- College graduate
- Use of psychotropic drugs
- Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data
- Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months
- Currently pregnant or nursing
- Uncontrolled serious psychotic illness or substance abuse
- History of difficulties providing blood samples-fainting, poor veins, anxiety
Data sourced from ClinicalTrials.gov (NCT01928719). 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.