Trial Outcomes & Findings for Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers (NCT NCT05004662)
NCT ID: NCT05004662
Last Updated: 2026-08-04
Results Overview
Participants who report no smoking, not even a puff, within the past 7 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
502 participants
Primary outcome timeframe
12 Month Follow-Up
Results posted on
2026-08-04
Participant Flow
Participant milestones
| Measure |
Standard Treatment
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's Quitline services to receive smoking cessation treatment.
|
Automated Treatment
Participants randomized to Automated Treatment (AT) are given a 10-week supply of nicotine patches and lozenges. AT also comprises: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
|
|---|---|---|
|
Overall Study
STARTED
|
251
|
251
|
|
Overall Study
COMPLETED
|
249
|
250
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers
Baseline characteristics by cohort
| Measure |
Standard Treatment
n=249 Participants
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's Quitline services to receive smoking cessation treatment.
|
Automated Treatment
n=250 Participants
Participants randomized to Automated Treatment (AT) are given a 10-week supply of nicotine patches and lozenges. AT will also comprise: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
|
Total
n=499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
237 Participants
n=20 Participants
|
230 Participants
n=20 Participants
|
467 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=20 Participants
|
182 Participants
n=20 Participants
|
364 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=20 Participants
|
68 Participants
n=20 Participants
|
135 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=20 Participants
|
38 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
226 Participants
n=20 Participants
|
212 Participants
n=20 Participants
|
438 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=20 Participants
|
41 Participants
n=20 Participants
|
81 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
192 Participants
n=20 Participants
|
182 Participants
n=20 Participants
|
374 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
249 participants
n=20 Participants
|
250 participants
n=20 Participants
|
499 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 12 Month Follow-UpParticipants who report no smoking, not even a puff, within the past 7 days
Outcome measures
| Measure |
Standard Treatment
n=249 Participants
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's Quitline services to receive smoking cessation treatment.
|
Automated Treatment
n=250 Participants
Participants randomized to Automated Treatment (AT) are given a 10-week supply of nicotine patches and lozenges. AT will also comprise: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
|
|---|---|---|
|
Self-Reported 7-Day Point-Prevalence Smoking Abstinence
|
89 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: 12 Month Follow-UpInvestigators will biochemically verify smoking status by collecting cotinine samples via salivary cotinine kit
Outcome measures
| Measure |
Standard Treatment
n=249 Participants
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's Quitline services to receive smoking cessation treatment.
|
Automated Treatment
n=250 Participants
Participants randomized to Automated Treatment (AT) are given a 10-week supply of nicotine patches and lozenges. AT will also comprise: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
|
|---|---|---|
|
Biochemical Verification Via Salivary Cotinine
|
42 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 12 Month Follow-UpNumber of participants who report no smoking, not even a puff, within the past 24 hours
Outcome measures
| Measure |
Standard Treatment
n=249 Participants
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's Quitline services to receive smoking cessation treatment.
|
Automated Treatment
n=250 Participants
Participants randomized to Automated Treatment (AT) are given a 10-week supply of nicotine patches and lozenges. AT will also comprise: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
|
|---|---|---|
|
Self-Reported 24-Hour Point-Prevalence Smoking Abstinence
|
113 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: 12 Month Follow-UpNumber of participants who report no smoking, not even a puff, within the past 30 days
Outcome measures
| Measure |
Standard Treatment
n=249 Participants
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's Quitline services to receive smoking cessation treatment.
|
Automated Treatment
n=250 Participants
Participants randomized to Automated Treatment (AT) are given a 10-week supply of nicotine patches and lozenges. AT will also comprise: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
|
|---|---|---|
|
Self-Reported 30-Day Point-Prevalence Smoking Abstinence
|
77 Participants
|
79 Participants
|
Adverse Events
Standard Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Automated Treatment
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place