Trial Outcomes & Findings for Highdose Nicotine Patch Therapy for Smokeless Tobacco Use (NCT NCT00939029)
NCT ID: NCT00939029
Last Updated: 2014-05-19
Results Overview
7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine \< 2 ng per ml
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
52 participants
Primary outcome timeframe
weeks 8
Results posted on
2014-05-19
Participant Flow
Participant milestones
| Measure |
Active
2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks
|
Placebo
2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
12
|
Reasons for withdrawal
| Measure |
Active
2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks
|
Placebo
2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Highdose Nicotine Patch Therapy for Smokeless Tobacco Use
Baseline characteristics by cohort
| Measure |
Active
n=25 Participants
2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks
|
Placebo
n=27 Participants
2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian, non-Hispanic
|
23 participants
n=5 Participants
|
26 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian, Hispanic
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Smokeless tobacco use
|
4.6 cans or pouches per week
STANDARD_DEVIATION 1.8 • n=5 Participants
|
4.0 cans or pouches per week
STANDARD_DEVIATION 1.3 • n=7 Participants
|
4.3 cans or pouches per week
STANDARD_DEVIATION 1.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: weeks 8Population: intention to treat
7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine \< 2 ng per ml
Outcome measures
| Measure |
Active
n=25 Participants
2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks
|
Placebo
n=27 Participants
2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks
|
|---|---|---|
|
End of Treatment (Week 8) Point Prevalence Abstinence
|
11 participants
|
6 participants
|
SECONDARY outcome
Timeframe: week 12Population: intention to treat
7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine \< 2 ng per ml
Outcome measures
| Measure |
Active
n=25 Participants
2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks
|
Placebo
n=27 Participants
2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks
|
|---|---|---|
|
Point-prevalence Abstinence at 3 Months
|
12 participants
|
5 participants
|
SECONDARY outcome
Timeframe: week 24Population: intention to treat
7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine \< 2 ng per ml.
Outcome measures
| Measure |
Active
n=25 Participants
2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks
|
Placebo
n=27 Participants
2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks
|
|---|---|---|
|
Point-prevalence Abstinence at 6 Months
|
11 participants
|
7 participants
|
Adverse Events
Active
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active
n=25 participants at risk
2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks
|
Placebo
n=27 participants at risk
2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks
|
|---|---|---|
|
Infections and infestations
Infection
|
4.0%
1/25 • Number of events 1
|
0.00%
0/27
|
Other adverse events
| Measure |
Active
n=25 participants at risk
2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks
nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks
|
Placebo
n=27 participants at risk
2 patches (containing non active ingredients) per day for 8 weeks
placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
patch site reaction
|
8.0%
2/25
|
7.4%
2/27
|
|
Gastrointestinal disorders
nausea
|
8.0%
2/25
|
0.00%
0/27
|
|
General disorders
anxiety
|
4.0%
1/25
|
0.00%
0/27
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/25
|
3.7%
1/27
|
|
General disorders
dizziness
|
4.0%
1/25
|
0.00%
0/27
|
|
General disorders
irritability
|
0.00%
0/25
|
3.7%
1/27
|
|
General disorders
itching
|
4.0%
1/25
|
0.00%
0/27
|
|
General disorders
sleep disturbance
|
0.00%
0/25
|
3.7%
1/27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place