Trial Outcomes & Findings for CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes (NCT NCT06087328)
NCT ID: NCT06087328
Last Updated: 2025-11-26
Results Overview
Number of days participants self-report abstinence from both e-cigarettes and smoking.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Day 28, Day 56
Results posted on
2025-11-26
Participant Flow
From December 2023-September 2024, 46 participants were recruited from online advertisements.
Following consent, all females underwent a pregnancy test to ensure final eligibility for the study prior to randomization.
Participant milestones
| Measure |
Arm A
21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]
|
Arm B
21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]
|
Arm C
2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]
|
|---|---|---|---|
|
28-Day Treatment
STARTED
|
16
|
15
|
15
|
|
28-Day Treatment
COMPLETED
|
9
|
12
|
11
|
|
28-Day Treatment
NOT COMPLETED
|
7
|
3
|
4
|
|
1-month Follow-up
STARTED
|
9
|
12
|
11
|
|
1-month Follow-up
COMPLETED
|
9
|
11
|
10
|
|
1-month Follow-up
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm A
21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]
|
Arm B
21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]
|
Arm C
2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]
|
|---|---|---|---|
|
28-Day Treatment
Lost to Follow-up
|
7
|
3
|
4
|
|
1-month Follow-up
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes
Baseline characteristics by cohort
| Measure |
Arm A
n=16 Participants
21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]
|
Arm B
n=15 Participants
21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]
|
Arm C
n=15 Participants
2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.1 Years
STANDARD_DEVIATION 7.7 • n=9 Participants
|
39.3 Years
STANDARD_DEVIATION 11.8 • n=32 Participants
|
36.0 Years
STANDARD_DEVIATION 11.1 • n=18 Participants
|
37.8 Years
STANDARD_DEVIATION 10.1 • n=78 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=9 Participants
|
6 Participants
n=32 Participants
|
8 Participants
n=18 Participants
|
26 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
9 Participants
n=32 Participants
|
7 Participants
n=18 Participants
|
20 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=9 Participants
|
14 Participants
n=32 Participants
|
14 Participants
n=18 Participants
|
42 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=78 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
0 Participants
n=18 Participants
|
4 Participants
n=78 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
11 Participants
n=32 Participants
|
13 Participants
n=18 Participants
|
38 Participants
n=78 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=78 Participants
|
|
Dependence
Low
|
2 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=18 Participants
|
6 Participants
n=78 Participants
|
|
Dependence
High
|
14 Participants
n=9 Participants
|
13 Participants
n=32 Participants
|
13 Participants
n=18 Participants
|
40 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: Day 28, Day 56Number of days participants self-report abstinence from both e-cigarettes and smoking.
Outcome measures
| Measure |
Arm A
n=16 Participants
21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]
|
Arm B
n=15 Participants
21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]
|
Arm C
n=15 Participants
2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]
|
|---|---|---|---|
|
Days of Dual Use Abstinence
Dual Abstinence Days 1-28
|
3.8 Days
Standard Deviation 7.8
|
11.2 Days
Standard Deviation 8.7
|
6.9 Days
Standard Deviation 10.3
|
|
Days of Dual Use Abstinence
Dual Abstinence Days 1-56
|
4.6 Days
Standard Deviation 8.3
|
23.8 Days
Standard Deviation 20.9
|
16.1 Days
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: Day 28, Day 56Calculate the reduction of e-cigarette use and smoking between groups from baseline to end of treatment.
Outcome measures
| Measure |
Arm A
n=16 Participants
21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]
|
Arm B
n=15 Participants
21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]
|
Arm C
n=15 Participants
2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]
|
|---|---|---|---|
|
Reduction
Reduction in Days of E-cigarette Use Before and During Treatment (Days 1-28)
|
6.1 Days
Standard Deviation 10.5
|
13.5 Days
Standard Deviation 10.7
|
9.5 Days
Standard Deviation 11.0
|
|
Reduction
Reduction in Days of Cigarette Use Before and During Treatment (Days 1-28)
|
7.9 Days
Standard Deviation 13.2
|
16.4 Days
Standard Deviation 10.3
|
12.2 Days
Standard Deviation 12.9
|
|
Reduction
Reduction in Days of E-Cigarette Use Before and After Treatment (Days 29-56)
|
3.2 Days
Standard Deviation 8.6
|
12.5 Days
Standard Deviation 15.0
|
9.3 Days
Standard Deviation 13.6
|
|
Reduction
Reduction in Cigarette Use Before and After Treatment (Days 29-56)
|
8.2 Days
Standard Deviation 15.2
|
19.5 Days
Standard Deviation 13.0
|
12.4 Days
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Day 28Adverse events and outcomes between groups will be evaluated.
Outcome measures
| Measure |
Arm A
n=16 Participants
21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]
|
Arm B
n=15 Participants
21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]
|
Arm C
n=15 Participants
2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]
|
|---|---|---|---|
|
Safety (Adverse Events)
Any Adverse Event
|
9 Participants
|
13 Participants
|
10 Participants
|
|
Safety (Adverse Events)
Any Severe Adverse Event (self-reported severity rating)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Safety (Adverse Events)
Any Doctor/Clinic/Hospital Visit due to Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Participants in the 'Eligible and Contacted' arm were only assessed for enrollment; survey completion was not measured. Participants in the 'Enrolled' arm were only assessed for survey completion; enrollment was not measured. Therefore, some rows have zero analyzed counts because those measures were not applicable to that arm.
Feasibility and acceptability were assessed by the proportion of eligible participants who enrolled, and among enrolled participants, the proportion who completed the Day 28 survey and the proportion who completed ≥80% of daily surveys during treatment.
Outcome measures
| Measure |
Arm A
n=46 Participants
21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]
|
Arm B
n=37 Participants
21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]
|
Arm C
2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]
|
|---|---|---|---|
|
Feasibility/Acceptability
Eligible & Contacted · Completed Day 28 Survey
|
0 Participants
|
0 Participants
|
—
|
|
Feasibility/Acceptability
Eligible & Contacted · Completed >=80% of Daily Surveys
|
0 Participants
|
0 Participants
|
—
|
|
Feasibility/Acceptability
Enrolled · Enrolled
|
0 Participants
|
0 Participants
|
—
|
|
Feasibility/Acceptability
Enrolled · Completed Day 28 Survey
|
0 Participants
|
25 Participants
|
—
|
|
Feasibility/Acceptability
Enrolled · Completed >=80% of Daily Surveys
|
0 Participants
|
12 Participants
|
—
|
|
Feasibility/Acceptability
Eligible & Contacted · Enrolled
|
46 Participants
|
0 Participants
|
—
|
Adverse Events
Arm A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm B
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm C
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A
n=16 participants at risk
21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]
|
Arm B
n=15 participants at risk
21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]
|
Arm C
n=15 participants at risk
2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
26.7%
4/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
13.3%
2/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
|
Nervous system disorders
Headaches
|
37.5%
6/16 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
46.7%
7/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
13.3%
2/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
6.2%
1/16 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
13.3%
2/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
13.3%
2/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Irritation of nose, throat, or eyes
|
6.2%
1/16 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
0.00%
0/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
20.0%
3/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
|
Psychiatric disorders
Difficulty sleeping
|
18.8%
3/16 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
40.0%
6/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
13.3%
2/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
|
Psychiatric disorders
Vivid dreams
|
25.0%
4/16 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
46.7%
7/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
20.0%
3/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
|
Gastrointestinal disorders
Upset stomach
|
18.8%
3/16 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
33.3%
5/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
33.3%
5/15 • Days 1-28 of the study (i.e., treatment period).
Adverse events (i.e., NRT side effects) were captured via the SAFTEE (Systematic Assessment for Treatment Emergent Events) on daily surveys during treatment.
|
Additional Information
Amanda M. Palmer, PhD
Medical University of South Carolina
Phone: 843-792-1413
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place