Trial Outcomes & Findings for Methadone-Maintained Smokers Switching to E-Cigarettes (NCT NCT05206435)
NCT ID: NCT05206435
Last Updated: 2026-08-20
Results Overview
urinary measure of NNAL
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
183 participants
Primary outcome timeframe
6 weeks
Results posted on
2026-08-20
Participant Flow
Participant milestones
| Measure |
Electronic Cigarettes
Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.
|
Nicotine Lozenges
Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
59
|
|
Overall Study
COMPLETED
|
119
|
52
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Methadone-Maintained Smokers Switching to E-Cigarettes
Baseline characteristics by cohort
| Measure |
Nicotine Lozenges
n=59 Participants
Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.
|
Total
n=183 Participants
Total of all reporting groups
|
Electronic Cigarettes
n=124 Participants
Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=109 Participants
|
147 Participants
n=133 Participants
|
100 Participants
n=5 Participants
|
|
Age, Continuous
|
43.12 years
STANDARD_DEVIATION 9.91 • n=109 Participants
|
43.11 years
STANDARD_DEVIATION 9.92 • n=133 Participants
|
43.11 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=109 Participants
|
82 Participants
n=133 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=109 Participants
|
101 Participants
n=133 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=109 Participants
|
3 Participants
n=133 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=109 Participants
|
5 Participants
n=133 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=109 Participants
|
143 Participants
n=133 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=109 Participants
|
31 Participants
n=133 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=109 Participants
|
36 Participants
n=133 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=5 Participants
|
|
cigarettes per day
|
18.17 cigarettes per day
STANDARD_DEVIATION 7.86 • n=109 Participants
|
17.50 cigarettes per day
STANDARD_DEVIATION 7.81 • n=133 Participants
|
17.19 cigarettes per day
STANDARD_DEVIATION 7.80 • n=5 Participants
|
|
NNAL
|
.30 ng/mg
STANDARD_DEVIATION .31 • n=109 Participants
|
.29 ng/mg
STANDARD_DEVIATION .28 • n=133 Participants
|
.29 ng/mg
STANDARD_DEVIATION .26 • n=5 Participants
|
|
NNN
|
.05 ng/mg
STANDARD_DEVIATION .17 • n=109 Participants
|
.04 ng/mg
STANDARD_DEVIATION .10 • n=133 Participants
|
.04 ng/mg
STANDARD_DEVIATION .05 • n=5 Participants
|
|
3-HPMA
|
721.13 ng/mg
STANDARD_DEVIATION 621.42 • n=109 Participants
|
721.48 ng/mg
STANDARD_DEVIATION 804.24 • n=133 Participants
|
721.65 ng/mg
STANDARD_DEVIATION 880.28 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksurinary measure of NNAL
Outcome measures
| Measure |
Electronic Cigarettes
n=94 Participants
Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.
|
Nicotine Lozenges
n=39 Participants
Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.
|
|---|---|---|
|
NNAL
|
.21 ng/mg
Standard Deviation .28
|
.20 ng/mg
Standard Deviation .24
|
PRIMARY outcome
Timeframe: 6 weeksUrinary measure of NNN
Outcome measures
| Measure |
Electronic Cigarettes
n=102 Participants
Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.
|
Nicotine Lozenges
n=44 Participants
Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.
|
|---|---|---|
|
NNN
|
.087 ng/mg
Standard Deviation .210
|
.069 ng/mg
Standard Deviation .158
|
PRIMARY outcome
Timeframe: 6 weeksUrinary measure of 3-HPMA
Outcome measures
| Measure |
Electronic Cigarettes
n=105 Participants
Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.
|
Nicotine Lozenges
n=45 Participants
Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.
|
|---|---|---|
|
3-HPMA
|
567.92 ng/mg
Standard Deviation 604.34
|
707.09 ng/mg
Standard Deviation 667.20
|
SECONDARY outcome
Timeframe: 6 weeksMean number of cigarettes per day assessed via the Timeline Followback over the last 6 weeks
Outcome measures
| Measure |
Electronic Cigarettes
n=119 Participants
Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.
|
Nicotine Lozenges
n=52 Participants
Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.
|
|---|---|---|
|
Cigarettes Per Day
|
8.68 cigarettes/day
Standard Deviation 6.89
|
10.87 cigarettes/day
Standard Deviation 7.33
|
Adverse Events
Electronic Cigarettes
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Nicotine Lozenges
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Electronic Cigarettes
n=124 participants at risk
Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.
|
Nicotine Lozenges
n=59 participants at risk
Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.
|
|---|---|---|
|
Cardiac disorders
mild heart attack
|
0.00%
0/124 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
1.7%
1/59 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
|
Surgical and medical procedures
bile duct surgery
|
0.81%
1/124 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
0.00%
0/59 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
|
Infections and infestations
hospitalization for leg infection
|
0.81%
1/124 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
0.00%
0/59 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
|
Injury, poisoning and procedural complications
hospitalization due to a fall (hit head)
|
0.81%
1/124 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
0.00%
0/59 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
|
Psychiatric disorders
inpatient detoxification
|
0.00%
0/124 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
1.7%
1/59 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
Other adverse events
| Measure |
Electronic Cigarettes
n=124 participants at risk
Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.
|
Nicotine Lozenges
n=59 participants at risk
Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.
|
|---|---|---|
|
Psychiatric disorders
suicidal ideation
|
1.6%
2/124 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
0.00%
0/59 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
|
Renal and urinary disorders
urinary tract infection
|
0.81%
1/124 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
0.00%
0/59 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
|
General disorders
mouth sore
|
0.00%
0/124 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
1.7%
1/59 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
|
Gastrointestinal disorders
vomiting and nausea
|
0.00%
0/124 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
1.7%
1/59 • from enrollment until the end of the follow-ups, up to 10 weeks
The Systematic Assessment for Treatment Emergent Effects (SAFTEE) measure was used to determine adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place