Trial Outcomes & Findings for SmokefreeSGM, A Text-based Smoking Cessation Feasibility Trial for Sexual and Gender Minority Groups (NCT NCT05645354)
NCT ID: NCT05645354
Last Updated: 2025-08-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Baseline
Results posted on
2025-08-17
Participant Flow
Of the 217 participants screened, 100 participants met all inclusion criteria, were enrolled and randomized.
Participant milestones
| Measure |
SmokefreeSGM
SmokefreeSGM: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.
|
SmokefreeTXT
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
Completed 1 Month Follow up
|
35
|
34
|
|
Overall Study
Completed 3 Month Follow up
|
22
|
20
|
|
Overall Study
Completed 6 Month Follow up
|
19
|
16
|
|
Overall Study
COMPLETED
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
31
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
Baseline characteristics by cohort
| Measure |
SmokefreeTXT
n=50 Participants
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
SmokefreeSGM
n=50 Participants
SmokefreeSGM: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 12.7 • n=50 Participants
|
38.2 years
STANDARD_DEVIATION 12.2 • n=50 Participants
|
41.1 years
STANDARD_DEVIATION 12.1 • n=100 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=50 Participants
|
27 Participants
n=50 Participants
|
57 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=50 Participants
|
23 Participants
n=50 Participants
|
43 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
29 Participants
n=50 Participants
|
31 Participants
n=50 Participants
|
60 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
10 Participants
n=50 Participants
|
15 Participants
n=50 Participants
|
25 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
10 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
5 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
50 participants
n=50 Participants
|
100 participants
n=100 Participants
|
|
Sexual Orientation
Gay Male/Bisexual Male
|
20 Participants
n=50 Participants
|
17 Participants
n=50 Participants
|
37 Participants
n=100 Participants
|
|
Sexual Orientation
Lesbian/Gay Woman/ Bisexual Female
|
24 Participants
n=50 Participants
|
26 Participants
n=50 Participants
|
50 Participants
n=100 Participants
|
|
Sexual Orientation
Others (pansexual, queer, unsure)
|
6 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
13 Participants
n=100 Participants
|
|
Work Status
Working
|
29 Participants
n=50 Participants
|
28 Participants
n=50 Participants
|
57 Participants
n=100 Participants
|
|
Work Status
Not Working
|
21 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
43 Participants
n=100 Participants
|
|
Level of Education
less than or equal to High school
|
9 Participants
n=50 Participants
|
13 Participants
n=50 Participants
|
22 Participants
n=100 Participants
|
|
Level of Education
Technical/vocational degree/ Completed some college
|
28 Participants
n=50 Participants
|
19 Participants
n=50 Participants
|
47 Participants
n=100 Participants
|
|
Level of Education
Bachelor's/ master's /associate degree
|
13 Participants
n=50 Participants
|
18 Participants
n=50 Participants
|
31 Participants
n=100 Participants
|
|
Marital Status
Single/Separate/Divorced/Widowed
|
36 Participants
n=50 Participants
|
36 Participants
n=50 Participants
|
72 Participants
n=100 Participants
|
|
Marital Status
Married/Living with significant other
|
14 Participants
n=50 Participants
|
14 Participants
n=50 Participants
|
28 Participants
n=100 Participants
|
|
Children in household
No
|
38 Participants
n=50 Participants
|
38 Participants
n=50 Participants
|
76 Participants
n=100 Participants
|
|
Children in household
Yes
|
12 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
24 Participants
n=100 Participants
|
|
Number of Participants who live with other smokers
|
19 Participants
n=50 Participants
|
16 Participants
n=50 Participants
|
35 Participants
n=100 Participants
|
|
Number of times participants tried to quit smoking
Never tried
|
2 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
6 Participants
n=100 Participants
|
|
Number of times participants tried to quit smoking
Between 1 and 10 times
|
35 Participants
n=50 Participants
|
38 Participants
n=50 Participants
|
73 Participants
n=100 Participants
|
|
Number of times participants tried to quit smoking
More than 10 times
|
13 Participants
n=50 Participants
|
8 Participants
n=50 Participants
|
21 Participants
n=100 Participants
|
|
Age at smoking initation
|
15.3 years
STANDARD_DEVIATION 2.7 • n=50 Participants
|
14.3 years
STANDARD_DEVIATION 3.3 • n=50 Participants
|
14.8 years
STANDARD_DEVIATION 3.1 • n=100 Participants
|
|
Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence
mild dependance on nicotine
|
11 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
22 Participants
n=100 Participants
|
|
Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence
moderate dependance on nicotine
|
33 Participants
n=50 Participants
|
22 Participants
n=50 Participants
|
55 Participants
n=100 Participants
|
|
Nicotine dependence as assessed by the Fagerstrom Test for Nicotine Dependence
severe dependance on nicotine
|
6 Participants
n=50 Participants
|
17 Participants
n=50 Participants
|
23 Participants
n=100 Participants
|
|
E-cigarette Dependence as assessed by Penn State E-cigarette Dependence Index
Not Dependent
|
8 Participants
n=27 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
4 Participants
n=13 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
12 Participants
n=40 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
|
E-cigarette Dependence as assessed by Penn State E-cigarette Dependence Index
Low dependence
|
6 Participants
n=27 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
3 Participants
n=13 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
9 Participants
n=40 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
|
E-cigarette Dependence as assessed by Penn State E-cigarette Dependence Index
medium dependence
|
5 Participants
n=27 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
2 Participants
n=13 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
7 Participants
n=40 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
|
E-cigarette Dependence as assessed by Penn State E-cigarette Dependence Index
high dependence
|
8 Participants
n=27 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
4 Participants
n=13 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
12 Participants
n=40 Participants • Data for this outcome measure was collected for only the participants who smoke electronic cigarettes.
|
|
Number of participants who smoke electronic cigarettes
|
27 Participants
n=50 Participants
|
13 Participants
n=50 Participants
|
40 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: BaselineOutcome measures
| Measure |
All Participants Screened
n=217 Participants
All Participants Screened
|
SmokefreeTXT
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
|---|---|---|
|
Feasibility as Assessed by Number of Participants Recruited for the Study
|
100 Participants
|
—
|
PRIMARY outcome
Timeframe: end of month 1Outcome measures
| Measure |
All Participants Screened
n=50 Participants
All Participants Screened
|
SmokefreeTXT
n=50 Participants
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
|---|---|---|
|
Feasibility as Assessed by Number of Participants That Completed Month 1 Visit
|
35 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: end of month 3Outcome measures
| Measure |
All Participants Screened
n=50 Participants
All Participants Screened
|
SmokefreeTXT
n=50 Participants
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
|---|---|---|
|
Feasibility as Assessed by Number of Participants That Completed Month 3 Visit
|
22 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: end of month 6Outcome measures
| Measure |
All Participants Screened
n=50 Participants
All Participants Screened
|
SmokefreeTXT
n=50 Participants
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
|---|---|---|
|
Feasibility as Assessed by Number of Participants That Completed Month 6 Visit
|
19 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 6 months follow upOutcome measures
| Measure |
All Participants Screened
n=19 Participants
All Participants Screened
|
SmokefreeTXT
n=16 Participants
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
|---|---|---|
|
Acceptability as Assessed by Number of Participants Who Completed Qualitative Interviews
|
16 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 month follow upOutcome measures
| Measure |
All Participants Screened
n=34 Participants
All Participants Screened
|
SmokefreeTXT
n=35 Participants
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
|---|---|---|
|
Number of Participants That Quit Smoking
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 3 month follow upOutcome measures
| Measure |
All Participants Screened
n=20 Participants
All Participants Screened
|
SmokefreeTXT
n=22 Participants
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
|---|---|---|
|
Number of Participants That Quit Smoking
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 month follow upOutcome measures
| Measure |
All Participants Screened
n=16 Participants
All Participants Screened
|
SmokefreeTXT
n=19 Participants
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
|---|---|---|
|
Number of Participants That Quit Smoking
|
3 Participants
|
7 Participants
|
Adverse Events
SmokefreeSGM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SmokefreeTXT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SmokefreeSGM
n=50 participants at risk
SmokefreeSGM: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of LGBTQ+ smokers.
|
SmokefreeTXT
n=50 participants at risk
SmokefreeTXT: Participants will be enrolled in a text-based smoking cessation program specifically designed to respond to the needs of the general population
|
|---|---|---|
|
General disorders
Nausea
|
0.00%
0/50 • Up to 6 months
|
2.0%
1/50 • Up to 6 months
|
|
General disorders
Palpitations
|
0.00%
0/50 • Up to 6 months
|
2.0%
1/50 • Up to 6 months
|
Additional Information
Irene Tami-Maury, DMD,MSc,DrPH-NHSN
The University of Texas Health Science Center at Houston
Phone: 713-500-9234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place