Trial Outcomes & Findings for Adapt2Quit - An Adaptive Motivational System for Socio-Economically Disadvantaged Smokers (NCT NCT04720625)

NCT ID: NCT04720625

Last Updated: 2026-07-31

Results Overview

Participants who self-reported no tobacco use in the past 7 days at the 6-month follow-up underwent biochemical verification using the CoVita Smokerlyzer breath carbon monoxide (CO) monitor. Participants with a CO measurement of ≤6 ppm were classified as abstinent; those with a CO measurement of \>6 ppm were classified as tobacco users.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

757 participants

Primary outcome timeframe

6-months post-randomization

Results posted on

2026-07-31

Participant Flow

Participant milestones

Participant milestones
Measure
Adapt2Quit
These participants will receive Adapt2Quit motivational messaging and Quitline facilitation messaging for 6 months. Adapt2Quit: Motivational text messages and Quitline facilitation text messages will be sent to participants; these participants will receive Adapt2Quit (experimental) messages as well as Quitline facilitation messages.
Control
These participants will receive Quitline facilitation-only messaging for 6 months. Control: Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.
Overall Study
STARTED
378
379
Overall Study
COMPLETED
315
324
Overall Study
NOT COMPLETED
63
55

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adapt2Quit - An Adaptive Motivational System for Socio-Economically Disadvantaged Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Adapt2Quit
n=378 Participants
These participants will receive Adapt2Quit motivational messaging and Quitline facilitation messaging for 6 months. Adapt2Quit: Motivational text messages and Quitline facilitation text messages will be sent to participants; these participants will receive Adapt2Quit (experimental) messages as well as Quitline facilitation messages.
Control
n=379 Participants
These participants will receive Quitline facilitation-only messaging for 6 months. Control: Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.
Total
n=757 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Age, Categorical
Between 18 and 65 years
332 Participants
n=9 Participants
353 Participants
n=27 Participants
685 Participants
n=267 Participants
Age, Categorical
>=65 years
46 Participants
n=9 Participants
26 Participants
n=27 Participants
72 Participants
n=267 Participants
Sex: Female, Male
Female
253 Participants
n=9 Participants
234 Participants
n=27 Participants
487 Participants
n=267 Participants
Sex: Female, Male
Male
125 Participants
n=9 Participants
145 Participants
n=27 Participants
270 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
55 Participants
n=9 Participants
50 Participants
n=27 Participants
105 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
297 Participants
n=9 Participants
316 Participants
n=27 Participants
613 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
26 Participants
n=9 Participants
13 Participants
n=27 Participants
39 Participants
n=267 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
n=9 Participants
3 Participants
n=27 Participants
6 Participants
n=267 Participants
Race (NIH/OMB)
Asian
3 Participants
n=9 Participants
2 Participants
n=27 Participants
5 Participants
n=267 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Black or African American
128 Participants
n=9 Participants
132 Participants
n=27 Participants
260 Participants
n=267 Participants
Race (NIH/OMB)
White
197 Participants
n=9 Participants
195 Participants
n=27 Participants
392 Participants
n=267 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=9 Participants
1 Participants
n=27 Participants
2 Participants
n=267 Participants
Race (NIH/OMB)
Unknown or Not Reported
46 Participants
n=9 Participants
46 Participants
n=27 Participants
92 Participants
n=267 Participants
Region of Enrollment
United States
378 participants
n=9 Participants
379 participants
n=27 Participants
757 participants
n=267 Participants

PRIMARY outcome

Timeframe: 6-months post-randomization

Participants who self-reported no tobacco use in the past 7 days at the 6-month follow-up underwent biochemical verification using the CoVita Smokerlyzer breath carbon monoxide (CO) monitor. Participants with a CO measurement of ≤6 ppm were classified as abstinent; those with a CO measurement of \>6 ppm were classified as tobacco users.

Outcome measures

Outcome measures
Measure
Adapt2Quit
n=280 Participants
These participants will receive Adapt2Quit motivational messaging and Quitline facilitation messaging for 6 months. Adapt2Quit: Motivational text messages and Quitline facilitation text messages will be sent to participants; these participants will receive Adapt2Quit (experimental) messages as well as Quitline facilitation messages.
Control
n=293 Participants
These participants will receive Quitline facilitation-only messaging for 6 months. Control: Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.
Number of Participants With Biochemically Verified 7-Day Point Prevalence Tobacco Abstinence at 6 Months
21 Participants
18 Participants

SECONDARY outcome

Timeframe: 6-months post-randomization

Population: The analysis included participants with complete 6-month self-reported smoking status data. One participant who completed the 6-month follow-up did not answer the smoking status question and was excluded from the complete-case analysis.

Self-reported cigarette abstinence was assessed at the 6-month follow-up using the question: "Do you currently smoke cigarettes, even one puff in the last 7 days?" Participants who answered "No" were classified as self-reported abstinent.

Outcome measures

Outcome measures
Measure
Adapt2Quit
n=314 Participants
These participants will receive Adapt2Quit motivational messaging and Quitline facilitation messaging for 6 months. Adapt2Quit: Motivational text messages and Quitline facilitation text messages will be sent to participants; these participants will receive Adapt2Quit (experimental) messages as well as Quitline facilitation messages.
Control
n=324 Participants
These participants will receive Quitline facilitation-only messaging for 6 months. Control: Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.
Number of Participants With Self-Reported 7-Day Point Prevalence Cigarette Abstinence at 6 Months
58 Participants
58 Participants

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Adapt2Quit

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rajani Sadasivam, PhD, Professor

UMass Chan Medical School

Phone: 508-856-8924

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place