Trial Outcomes & Findings for Project Q Pilot: Smoking Cessation for Light Smokers (NCT NCT03416621)
NCT ID: NCT03416621
Last Updated: 2021-03-29
Results Overview
Feasibility will be determined by number of participants that complete at least 2 study visits.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
Approximately 8 weeks
Results posted on
2021-03-29
Participant Flow
Participant milestones
| Measure |
Experimental: Cognitive Behavioral Cessation Counseling
Standard smoking cessation plus support text messages
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
|
Placebo Comparator: Counseling and Placebo Drug Intervention
enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
Counseling and placebo drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
|
Active Comparator: Counseling and Active Drug Intervention
enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
6
|
|
Overall Study
COMPLETED
|
13
|
11
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Project Q Pilot: Smoking Cessation for Light Smokers
Baseline characteristics by cohort
| Measure |
Experimental: Cue-based Treatment
n=13 Participants
Enhanced cue exposure treatment (lab-based + interactive SMS texting)
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
|
Comparator: Standard Counseling
n=11 Participants
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
|
Active Comparator: Counseling and Active Drug Intervention
n=3 Participants
enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 18.4 • n=7 Participants
|
43 years
STANDARD_DEVIATION 24 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 16.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Education: Some college or college grad
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Employment status: Employed
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Type of smoker
Daily
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Type of smoker
Intermittent
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Cigarettes per day
|
5.8 cigarettes per day
STANDARD_DEVIATION 2.5 • n=5 Participants
|
6.5 cigarettes per day
STANDARD_DEVIATION 2.0 • n=7 Participants
|
7 cigarettes per day
STANDARD_DEVIATION 3.6 • n=5 Participants
|
6.1 cigarettes per day
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
Nicotine Dependence
|
2.8 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
1.7 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 1.9 • n=4 Participants
|
|
Native Light Smoker
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Approximately 8 weeksPopulation: Only one participant in the "Active Comparator" arm completed the study.
Feasibility will be determined by number of participants that complete at least 2 study visits.
Outcome measures
| Measure |
Experimental: Cue-based Treatment
n=13 Participants
enhanced cue exposure treatment (lab-based + interactive SMS texting)
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
|
Control: Standard Counseling
n=11 Participants
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
|
Active Comparator: Counseling and Active Drug Intervention
n=1 Participants
enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
|
|---|---|---|---|
|
Number of Participants With Completion of at Least 2 Study Visits
|
10 Participants
|
7 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Approximately 8 weeksPopulation: The primary outcome was defined as acceptability across the entire sample.
Acceptability will be determined by the number of patients rating the intervention usefulness in the experimental and control arms on a 7-point Likert scale, where 1=extremely useless and 7=extremely useful.
Outcome measures
| Measure |
Experimental: Cue-based Treatment
n=25 Participants
enhanced cue exposure treatment (lab-based + interactive SMS texting)
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
|
Control: Standard Counseling
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
|
Active Comparator: Counseling and Active Drug Intervention
enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
|
|---|---|---|---|
|
Number of Participants Who Rated the Intervention Acceptable
|
23 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 week post-interventionPopulation: Only one participant in the "Active Comparator" arm completed the study.
Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention.
Outcome measures
| Measure |
Experimental: Cue-based Treatment
n=13 Participants
enhanced cue exposure treatment (lab-based + interactive SMS texting)
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
|
Control: Standard Counseling
n=11 Participants
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
|
Active Comparator: Counseling and Active Drug Intervention
n=1 Participants
enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
Cognitive behavioral cessation counseling: Standard smoking cessation plus support text messages
Counseling and active drug intervention: Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
|
|---|---|---|---|
|
Number of Participants With Validated Cessation
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Experimental: Cognitive Behavioral Cessation Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Comparator: Counseling and Placebo Drug Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Counseling and Active Drug Intervention
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