Trial Outcomes & Findings for Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts (NCT NCT04994444)
NCT ID: NCT04994444
Last Updated: 2025-04-06
Results Overview
Number of days of nicotine patch use during the 8 weeks of provision
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
49 participants
Primary outcome timeframe
week 12
Results posted on
2025-04-06
Participant Flow
Participant milestones
| Measure |
Preloading
Participants will be started on nicotine patch 3 weeks prior to quit date. At quit date they will use patch and lozenge or gum for 8 weeks.
Nicoderm CQ 21Mg/24Hr Transdermal System: Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.
|
Standard Treatment
Participants will start combination nicotine replacement therapy (patch/gum or patch/lozenge) on their assigned quit date. NRT will be provided for 8 weeks.
Nicoderm CQ 21Mg/24Hr Transdermal System: Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
26
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts
Baseline characteristics by cohort
| Measure |
Preloading
n=23 Participants
Participants will be started on nicotine patch 3 weeks prior to quit date. At quit date they will use patch and lozenge or gum for 8 weeks.
Nicoderm CQ 21Mg/24Hr Transdermal System: Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.
|
Standard Treatment
n=26 Participants
Participants will start combination nicotine replacement therapy (patch/gum or patch/lozenge) on their assigned quit date. NRT will be provided for 8 weeks.
Nicoderm CQ 21Mg/24Hr Transdermal System: Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.0 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
sex · Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
sex · Male
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Cigarettes smoked per day
|
14.1 cigarettes per day
STANDARD_DEVIATION 8.6 • n=5 Participants
|
15.5 cigarettes per day
STANDARD_DEVIATION 9.8 • n=7 Participants
|
14.9 cigarettes per day
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Years of smoking cigarettes
|
32.2 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
31.0 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Fagerstrom test of cigarette dependence (FTCD)
|
4.7 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Confidence to Quit
|
7.2 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: week 12Number of days of nicotine patch use during the 8 weeks of provision
Outcome measures
| Measure |
Preloading
n=23 Participants
Participants will be started on nicotine patch 3 weeks prior to quit date. At quit date they will use patch and lozenge or gum for 8 weeks.
Nicoderm CQ 21Mg/24Hr Transdermal System: Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.
|
Standard Treatment
n=26 Participants
Participants will start combination nicotine replacement therapy (patch/gum or patch/lozenge) on their assigned quit date. NRT will be provided for 8 weeks.
Nicoderm CQ 21Mg/24Hr Transdermal System: Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.
|
|---|---|---|
|
Adherence to NRT
|
47.4 days of NRT use
Standard Deviation 13.2
|
32.7 days of NRT use
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: week 16number of participants who reported no cigarette smoking in past 7 days
Outcome measures
| Measure |
Preloading
n=23 Participants
Participants will be started on nicotine patch 3 weeks prior to quit date. At quit date they will use patch and lozenge or gum for 8 weeks.
Nicoderm CQ 21Mg/24Hr Transdermal System: Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.
|
Standard Treatment
n=26 Participants
Participants will start combination nicotine replacement therapy (patch/gum or patch/lozenge) on their assigned quit date. NRT will be provided for 8 weeks.
Nicoderm CQ 21Mg/24Hr Transdermal System: Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.
|
|---|---|---|
|
7 Day Point Prevalence Abstinence
|
4 Participants
|
4 Participants
|
Adverse Events
Preloading
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard 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