21 and older, any sex, with Cigarette Smoking-Related Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cigarettes Per DayPrimary· 2 weeks
Mean cigarettes per day (CPD) smoked during the phase
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
14.20
± 9.01
Placebo Standardized Research Electronic Cigarette Phase (Men)
4.08
± 6.31
Nicotine Standardized Research Electronic Cigarette Phase (Men)
4.55
± 7.25
Usual Brand Cigarette Phase (Women)
14.09
± 7.66
Placebo Standardized Research Electronic Cigarette Phase (Women)
3.85
± 5.30
Nicotine Standardized Research Electronic Cigarette Phase (Women)
3.63
± 4.72
Electronic Cigarette Sessions Per DaySecondary· 2 weeks
Study electronic cigarette use measured by the mean number of sessions per day during each phase for male and female participants.
Group
Value
95% CI
Placebo Standardized Research Electronic Cigarette Phase (Men)
11.32
± 9.49
Nicotine Standardized Research Electronic Cigarette Phase (Men)
10.33
± 8.93
Placebo Standardized Research Electronic Cigarette Phase (Women)
10.78
± 9.28
Nicotine Standardized Research Electronic Cigarette Phase (Women)
10.84
± 10.84
Total Nicotine Equivalents (TNE)Secondary· 2 weeks
A measure of nicotine exposure, calculated as the sum of total nicotine, cotinine, 3'-hydroxycotinine, and nicotine N-oxide excreted in urine, collected at the end of each phase for male and female participants.
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
42.01
± 37.40
Placebo Standardized Research Electronic Cigarette Phase (Men)
30.98
± 30.12
Nicotine Standardized Research Electronic Cigarette Phase (Men)
39.97
± 36.44
Usual Brand Cigarette Phase (Women)
41.19
± 33.44
Placebo Standardized Research Electronic Cigarette Phase (Women)
39.46
± 38.80
Nicotine Standardized Research Electronic Cigarette Phase (Women)
41.75
± 42.11
AnabasineSecondary· 2 weeks
A tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure.
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
92.69
± 155.35
Placebo Standardized Research Electronic Cigarette Phase (Men)
56.60
± 97.03
Nicotine Standardized Research Electronic Cigarette Phase (Men)
71.45
± 98.16
Usual Brand Cigarette Phase (Women)
76.19
± 92.95
Placebo Standardized Research Electronic Cigarette Phase (Women)
72.90
± 107.13
Nicotine Standardized Research Electronic Cigarette Phase (Women)
65.61
± 83.24
NicotellineSecondary· 2 weeks
A tobacco minor alkaloid (MA) excreted in urine collected at the end of each phase for male and female participants to evaluate nicotine product exposure.
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
0.64
± 4.53
Placebo Standardized Research Electronic Cigarette Phase (Men)
0.38
± 2.05
Nicotine Standardized Research Electronic Cigarette Phase (Men)
0.42
± 2.92
Usual Brand Cigarette Phase (Women)
1.63
± 7.98
Placebo Standardized Research Electronic Cigarette Phase (Women)
2.22
± 8.42
Nicotine Standardized Research Electronic Cigarette Phase (Women)
1.08
± 3.73
Perceived Health Risk Questionnaire (PHRQ)Secondary· 2 weeks
Evaluation of participants' beliefs about their risks of developing health conditions from cigarettes or electronic cigarette collected at the end of each phase for male and female participants. Range 1-10, with higher values indicating greater perceived risk of negative health outcomes.
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
8.15
± 2.18
Placebo Standardized Research Electronic Cigarette Phase (Men)
8.35
± 2.22
Nicotine Standardized Research Electronic Cigarette Phase (Men)
8.43
± 2.06
Usual Brand Cigarette Phase (Women)
9.05
± 1.99
Placebo Standardized Research Electronic Cigarette Phase (Women)
9.21
± 1.79
Nicotine Standardized Research Electronic Cigarette Phase (Women)
9.23
± 2.03
Product Evaluation Scales (PES)Secondary· 2 weeks
Evaluation of explicit cigarette or electronic cigarette product liking collected at the end of each phase for male and female participants. Range 1-7, with higher values indicating more unpleasant ratings.
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
4.33
± 0.98
Placebo Standardized Research Electronic Cigarette Phase (Men)
3.30
± 0.98
Nicotine Standardized Research Electronic Cigarette Phase (Men)
3.44
± 1.04
Usual Brand Cigarette Phase (Women)
4.51
± 1.12
Placebo Standardized Research Electronic Cigarette Phase (Women)
3.42
± 1.17
Nicotine Standardized Research Electronic Cigarette Phase (Women)
3.73
± 1.35
Implicit Association Test (IAT)Secondary· 2 weeks
Evaluation of implicit cigarette or electronic cigarette liking collected at the end of each phase for male and female participants. Range: -1 to 1, with more negative values indicating a more negative attitude toward the cigarette product
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
-0.29
± 0.53
Placebo Standardized Research Electronic Cigarette Phase (Men)
-0.17
± 0.48
Nicotine Standardized Research Electronic Cigarette Phase (Men)
-0.08
± 0.50
Usual Brand Cigarette Phase (Women)
-0.32
± 0.62
Placebo Standardized Research Electronic Cigarette Phase (Women)
-0.15
± 0.40
Nicotine Standardized Research Electronic Cigarette Phase (Women)
Evaluation of the perceived outcomes of cigarette or electronic cigarette use collected at the end of each phase for male and female participants. Range 0 to 9, with larger values indicating greater perceived negative consequences of cigarette use
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
4.56
± 1.22
Placebo Standardized Research Electronic Cigarette Phase (Men)
3.68
± 1.25
Nicotine Standardized Research Electronic Cigarette Phase (Men)
3.54
± 1.34
Usual Brand Cigarette Phase (Women)
4.61
± 1.25
Placebo Standardized Research Electronic Cigarette Phase (Women)
3.70
± 1.70
Nicotine Standardized Research Electronic Cigarette Phase (Women)
Evaluation of the Purchase Task Breakpoint measure (first price at which consumption goes to zero, i.e., unwilling to pay) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.05 - 251, dollars per cigarette or per electronic cigarette puff with higher values indicating the willingness to smoke/vape at a higher price.
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
13.67
± 22.12
Placebo Standardized Research Electronic Cigarette Phase (Men)
7.06
± 16.97
Nicotine Standardized Research Electronic Cigarette Phase (Men)
4.65
± 9.69
Usual Brand Cigarette Phase (Women)
14.25
± 33.22
Placebo Standardized Research Electronic Cigarette Phase (Women)
5.73
± 10.64
Nicotine Standardized Research Electronic Cigarette Phase (Women)
Evaluation of the Purchase Task Demand Intensity measure (consumption at the lowest price) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 1 - 351, the number of cigarettes or electronic cigarette puffs with higher values indicating an intension to smoke/vape more when the price is set as 0
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
20.52
± 14.37
Placebo Standardized Research Electronic Cigarette Phase (Men)
70.05
± 69.59
Nicotine Standardized Research Electronic Cigarette Phase (Men)
59.08
± 51.94
Usual Brand Cigarette Phase (Women)
19.05
± 13.14
Placebo Standardized Research Electronic Cigarette Phase (Women)
48.06
± 43.06
Nicotine Standardized Research Electronic Cigarette Phase (Women)
60.39
± 56.06
Purchase Task Omax MeasureSecondary· 2 weeks
Evaluation of the Purchase Task Omax measure (maximum financial expenditure on the product) for cigarettes or electronic cigarettes collected at the end of each phase for male and female participants. Range: 0.03 - 1001, the maximum expenditure in dollars on cigarettes or electronic cigarette puffs with higher values indicating greater expenditure
Group
Value
95% CI
Usual Brand Cigarette Phase (Men)
17.96
± 22.51
Placebo Standardized Research Electronic Cigarette Phase (Men)
24.74
± 72.92
Nicotine Standardized Research Electronic Cigarette Phase (Men)
11.73
± 13.09
Usual Brand Cigarette Phase (Women)
35.40
± 127.18
Placebo Standardized Research Electronic Cigarette Phase (Women)
13.51
± 23.20
Nicotine Standardized Research Electronic Cigarette Phase (Women)
19.94
± 65.14
Adverse events — posted to ClinicalTrials.gov
Time frame: 10 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Usual Brand Cigarette Phase (Men)
Serious: 0/87 (0%)
Deaths: 0/87
Placebo Standardized Research Electronic Cigarette Phase (Men)
Serious: 1/87 (1%)
Deaths: 0/87
Nicotine Standardized Research Electronic Cigarette Phase (Men)
Serious: 3/87 (3%)
Deaths: 0/87
Usual Brand Cigarette Phase (Women)
Serious: 1/82 (1%)
Deaths: 0/82
Placebo Standardized Research Electronic Cigarette Phase (Women)
Serious: 1/82 (1%)
Deaths: 0/82
Nicotine Standardized Research Electronic Cigarette Phase (Women)
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT06260683 — A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior
· NA
· recruiting
NCT05412875 — Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung
· NA
· withdrawn
NCT06745154 — Evaluating the Impact of Quitting Using Executive Function Strategy Training (QUEST) on Smoking Cessation in Homeless Yo
· NA
· completed
NCT05144542 — Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
· NA
· active not recruiting
NCT04694846 — Effectiveness of an Enhanced Tobacco Intervention Protocol Compared to Standard Treatment in Helping Head and Neck and L
· NA
· completed
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Currently open trials in the same condition.
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· recruiting
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· NA
· recruiting
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· NA
· recruiting
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· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 28 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03856515.