N/A
N=169
Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes
Cigarette Smoking-Related Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03856515 ↗Enrolled (actual)
169
Serious AEs
1.6%
Results posted
Jul 2025
Primary outcome: Primary: Cigarettes Per Day — 14.20; 4.08; 4.55; 14.09 Cigarettes per Day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nicotine Replacement (Drug); Questionnaire Administration (Other); Electronic Cigarette (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarettes Per Day |
14.20; 4.08; 4.55; 14.09; 3.85; 3.63 | — |
| SECONDARY Electronic Cigarette Sessions Per Day |
11.32; 10.33; 10.78; 10.84 | — |
| SECONDARY Total Nicotine Equivalents (TNE) |
42.01; 30.98; 39.97; 41.19; 39.46; 41.75 | — |
| SECONDARY Anabasine |
92.69; 56.60; 71.45; 76.19; 72.90; 65.61 | — |
| SECONDARY Nicotelline |
0.64; 0.38; 0.42; 1.63; 2.22; 1.08 | — |
| SECONDARY Perceived Health Risk Questionnaire (PHRQ) |
8.15; 8.35; 8.43; 9.05; 9.21; 9.23 | — |
| SECONDARY Product Evaluation Scales (PES) |
4.33; 3.30; 3.44; 4.51; 3.42; 3.73 | — |
| SECONDARY Implicit Association Test (IAT) |
-0.29; -0.17; -0.08; -0.32; -0.15; -0.25 | — |
| SECONDARY Brief Smoking Consequences Questionnaire-Adult (BSCQ-A) |
4.56; 3.68; 3.54; 4.61; 3.70; 3.72 | — |
| SECONDARY Purchase Task Breakpoint Measure |
13.67; 7.06; 4.65; 14.25; 5.73; 7.44 | — |
| SECONDARY Purchase Task Demand Intensity Measure |
20.52; 70.05; 59.08; 19.05; 48.06; 60.39 | — |
| SECONDARY Purchase Task Omax Measure |
17.96; 24.74; 11.73; 35.40; 13.51; 19.94 | — |
| SECONDARY Purchase Task Pmax Measure |
4.64; 2.86; 1.65; 17.93; 2.36; 3.39 | — |
| SECONDARY Purchase Task Elasticity of Demand Measure |
0.0070; 0.0130; 0.0177; 0.008; 0.026; 0.0298 | — |
| SECONDARY Fagerström Test for Cigarette Dependence (FTCD) |
4.54; 3.71; 3.67; 4.7; 3.97; 3.88 | — |
| SECONDARY Penn State Electronic Cigarette Dependence Index (PSECDI) |
7.78; 7.75; 8.87; 8.99 | — |
| SECONDARY Minnesota Nicotine Withdrawal Scale-Revised (MNWS) |
27.01; 27.02; 26.04; 28.81; 29.77; 28.08 | — |
| SECONDARY Questionnaire of Smoking Urges-Brief (QSU-Brief) |
4.16; 3.35; 3.26; 4.25; 3.43; 2.80 | — |
| SECONDARY Positive and Negative Affect Scales - Positive Affect Scale (PANAS-Pos) |
32.30; 31.12; 32.82; 32.80; 31.65; 33.03 | — |
| SECONDARY Positive and Negative Affect Scales - Negative Affect Scale (PANAS-Neg) |
16.43; 16.22; 15.53; 17.19; 17.73; 16.07 | — |
| SECONDARY Smartphone Daily Measures of Nicotine Dependence Symptoms |
2.40; 2.42; 2.34; 2.44; 2.53; 2.42 | — |
| SECONDARY American Thoracic Society Questionnaire (ATSQ) |
18.30; 16.85; 16.93; 18.17; 16.13; 16.08 | — |
Summary
This early phase I trial studies potential differences between men and women when switching from the use of combustible cigarettes to the National Institute on Drug Abuse's Standard Research E-Cigarette (SREC). Studying the differences between men and women may increase understanding about the effects of switching from smoking regular cigarettes to electronic cigarettes.
Eligibility Criteria
Inclusion Criteria
- Aged 21 years or older
- Reports being a daily or non-daily smoker (any self-reported smoking in the past 30 days)
- Have an address where he/she can receive mail
- Able to follow verbal and written instructions in English and complete all aspects of the study as determined by PI
- Willing to have urine biospecimen samples taken, either in-home and returning them by mail, or in-person at an approved collection site.
- Willing to use tobacco-flavored study electronic cigarettes
- Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit.
- The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle.
Exclusion Criteria
- Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above) or who report current suicidal ideation on the PHQ-9
- Uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes).
- Evidence of cognitive deficits or instability that would preclude reliable study participation.
- Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use.
- Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situation: unwilling or unable to comply with study procedures)
- Individuals who reside in an area that is outside of our shipping company's area of operation or in a jurisdiction outside of our medical staff's licensure (if unable to attend in-person clinic visits) AND who decline or are unable to come in to clinic to provide necessary samples and/or collect study products.
Data sourced from ClinicalTrials.gov (NCT03856515). 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.