Trial Outcomes & Findings for Provoked Craving Relief Study by NRT (NCT NCT01476202)
NCT ID: NCT01476202
Last Updated: 2013-09-30
Results Overview
Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration
Results posted on
2013-09-30
Participant Flow
Participants were recruited at the clinical site.
Of 140 screened participants, 120 were randomized while 17 participants were screen failures, and 3 participants were not randomized due to other reasons.
Participant milestones
| Measure |
Nicotine Mouth Strip 2.5 Milligram (mg)
Participants self administered a single dose of 2.5 mg nicotine mouth strip.
|
Nicotine Lozenge 2 mg
Participants self administered a single dose of 2 mg nicotine lozenge.
|
Nicotine Gum 2 mg
Participants self administered a single dose of 2 mg nicotine gum.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Provoked Craving Relief Study by NRT
Baseline characteristics by cohort
| Measure |
Nicotine Mouth Strip 2.5 mg
n=40 Participants
Participants self administered a single dose of 2.5 mg nicotine mouth strip.
|
Nicotine Lozenge 2 mg
n=40 Participants
Participants self administered a single dose of 2 mg nicotine lozenge.
|
Nicotine Gum 2 mg
n=40 Participants
Participants self administered a single dose of 2 mg nicotine lozenge.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
35.5 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
34.8 Years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
37.4 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
35.0 Years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administrationPopulation: Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.
Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.
Outcome measures
| Measure |
Nicotine Mouth Strip 2.5 mg
n=40 Participants
Participants self administered a single dose of 2.5 mg nicotine mouth strip.
|
Nicotine Lozenge 2 mg
n=40 Participants
Participants self administered a single dose of 2 mg nicotine lozenge.
|
Nicotine Gum 2 mg
n=40 Participants
Participants self administered a single dose of 2 mg nicotine gum.
|
|---|---|---|---|
|
Mean Change From Baseline in Nicotine Craving Score on a VAS
5 minutes
|
-35.8 Score on a scale
Standard Deviation 31.0
|
-18.3 Score on a scale
Standard Deviation 22.8
|
-27.2 Score on a scale
Standard Deviation 24.0
|
|
Mean Change From Baseline in Nicotine Craving Score on a VAS
7 minutes
|
-39.0 Score on a scale
Standard Deviation 33.2
|
-25.5 Score on a scale
Standard Deviation 27.2
|
-33.8 Score on a scale
Standard Deviation 27.5
|
|
Mean Change From Baseline in Nicotine Craving Score on a VAS
10 minutes
|
-43.9 Score on a scale
Standard Deviation 31.8
|
-30.0 Score on a scale
Standard Deviation 26.0
|
-38.4 Score on a scale
Standard Deviation 29.9
|
|
Mean Change From Baseline in Nicotine Craving Score on a VAS
50 seconds
|
-11.3 Score on a scale
Standard Deviation 17.2
|
-1.7 Score on a scale
Standard Deviation 6.0
|
-4.6 Score on a scale
Standard Deviation 9.0
|
|
Mean Change From Baseline in Nicotine Craving Score on a VAS
3 minutes
|
-28.2 Score on a scale
Standard Deviation 28.8
|
-12.0 Score on a scale
Standard Deviation 20.7
|
-17.6 Score on a scale
Standard Deviation 18.4
|
|
Mean Change From Baseline in Nicotine Craving Score on a VAS
15 minutes
|
-45.2 Score on a scale
Standard Deviation 33.3
|
-34.4 Score on a scale
Standard Deviation 29.1
|
-40.2 Score on a scale
Standard Deviation 30.7
|
|
Mean Change From Baseline in Nicotine Craving Score on a VAS
20 minutes
|
-47.9 Score on a scale
Standard Deviation 30.0
|
-37.4 Score on a scale
Standard Deviation 30.1
|
-42.7 Score on a scale
Standard Deviation 31.6
|
|
Mean Change From Baseline in Nicotine Craving Score on a VAS
25 minutes
|
-47.3 Score on a scale
Standard Deviation 33.8
|
-40.7 Score on a scale
Standard Deviation 30.9
|
-43.5 Score on a scale
Standard Deviation 29.7
|
|
Mean Change From Baseline in Nicotine Craving Score on a VAS
30 minutes
|
-45.2 Score on a scale
Standard Deviation 35.3
|
-42.8 Score on a scale
Standard Deviation 32.1
|
-42.3 Score on a scale
Standard Deviation 31.0
|
SECONDARY outcome
Timeframe: Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administrationPopulation: Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on LOCF technique.
AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined.
Outcome measures
| Measure |
Nicotine Mouth Strip 2.5 mg
n=40 Participants
Participants self administered a single dose of 2.5 mg nicotine mouth strip.
|
Nicotine Lozenge 2 mg
n=40 Participants
Participants self administered a single dose of 2 mg nicotine lozenge.
|
Nicotine Gum 2 mg
n=40 Participants
Participants self administered a single dose of 2 mg nicotine gum.
|
|---|---|---|---|
|
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC (0-50 seconds)
|
4.0 Score on a scale*minutes
Interval 3.99 to 4.05
|
4.1 Score on a scale*minutes
Interval 4.05 to 4.12
|
4.1 Score on a scale*minutes
Interval 4.03 to 4.1
|
|
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC (0-3 minutes)
|
5.1 Score on a scale*minutes
Interval 5.06 to 5.2
|
5.3 Score on a scale*minutes
Interval 5.23 to 5.38
|
5.2 Score on a scale*minutes
Interval 5.17 to 5.32
|
|
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC (0-5 minutes)
|
5.5 Score on a scale*minutes
Interval 5.42 to 5.61
|
5.7 Score on a scale*minutes
Interval 5.65 to 5.84
|
5.7 Score on a scale*minutes
Interval 5.57 to 5.76
|
|
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC (0-7 minutes)
|
5.8 Score on a scale*minutes
Interval 5.64 to 5.87
|
6.0 Score on a scale*minutes
Interval 5.89 to 6.12
|
5.9 Score on a scale*minutes
Interval 5.81 to 6.03
|
|
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC (0-10 minutes)
|
6.0 Score on a scale*minutes
Interval 5.88 to 6.14
|
6.3 Score on a scale*minutes
Interval 6.14 to 6.41
|
6.2 Score on a scale*minutes
Interval 6.05 to 6.31
|
|
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC (0-15 minutes)
|
6.3 Score on a scale*minutes
Interval 6.15 to 6.45
|
6.6 Score on a scale*minutes
Interval 6.42 to 6.73
|
6.5 Score on a scale*minutes
Interval 6.32 to 6.62
|
|
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC (0-20 minutes)
|
6.5 Score on a scale*minutes
Interval 6.35 to 6.68
|
6.8 Score on a scale*minutes
Interval 6.62 to 6.95
|
6.7 Score on a scale*minutes
Interval 6.5 to 6.83
|
|
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC (0-25 minutes)
|
6.7 Score on a scale*minutes
Interval 6.51 to 6.87
|
6.9 Score on a scale*minutes
Interval 6.76 to 7.12
|
6.8 Score on a scale*minutes
Interval 6.64 to 7.0
|
|
Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)
AUC (0-30 minutes)
|
6.8 Score on a scale*minutes
Interval 6.65 to 7.03
|
7.1 Score on a scale*minutes
Interval 6.87 to 7.25
|
7.0 Score on a scale*minutes
Interval 6.76 to 7.14
|
Adverse Events
Nicotine Mouth Strip 2.5 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nicotine Lozenge 2 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Nicotine Gum 2 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine Mouth Strip 2.5 mg
n=40 participants at risk
Participants self administered single dose of 2.5 mg nicotine mouth strip.
|
Nicotine Lozenge 2 mg
n=40 participants at risk
Participants self administered single dose of 2 mg nicotine lozenge.
|
Nicotine Gum 2 mg
n=40 participants at risk
Participants self administered single dose of 2 mg nicotine gum.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausae
|
0.00%
0/40 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
7.5%
3/40 • Number of events 3 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
0.00%
0/40 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/40 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
2.5%
1/40 • Number of events 1 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
0.00%
0/40 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
2.5%
1/40 • Number of events 1 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
0.00%
0/40 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
0.00%
0/40 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/40 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
2.5%
1/40 • Number of events 1 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
0.00%
0/40 • AEs were collected from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER