Trial Outcomes & Findings for Medicinal Nicotine for Preventing Cue Induced Craving (NCT NCT02347605)
NCT ID: NCT02347605
Last Updated: 2017-12-18
Results Overview
Craving as assessed via the craving question on the Minnesota Nicotine Withdrawal Scale. The score range is from 0 (no craving) to 4 (severe craving). The outcome measure is the change in craving score from before cue exposure to craving score after cue exposure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
approximately 15 minutes
Results posted on
2017-12-18
Participant Flow
Participant milestones
| Measure |
Sequence 1
Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
|
Sequence 2
Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
|
Sequence 3
Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
|
Sequence 4
Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
|
Sequence 5
Nicotine lozenge after cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
|
Sequence 6
Nicotine lozenge after cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
8
|
10
|
9
|
9
|
|
Overall Study
Completed Lab 1
|
10
|
10
|
8
|
10
|
8
|
9
|
|
Overall Study
Completed Lab 2
|
7
|
7
|
7
|
7
|
6
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
6
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
4
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medicinal Nicotine for Preventing Cue Induced Craving
Baseline characteristics by cohort
| Measure |
Sequence 1
n=10 Participants
Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
|
Sequence 2
n=10 Participants
Placebo lozenge 15 minute prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
|
Sequence 3
n=8 Participants
Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge after cue exposure at lab 3
|
Sequence 4
n=10 Participants
Nicotine lozenge 15 minutes prior to cue exposure at lab 1; Nicotine lozenge after cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
|
Sequence 5
n=9 Participants
Nicotine lozenge after cue exposure at lab 1; Placebo lozenge 15 minute prior to cue exposure at lab 2; Nicotine lozenge 15 minutes prior to cue exposure at lab 3
|
Sequence 6
n=9 Participants
Nicotine lozenge after cue exposure at lab 1; Nicotine lozenge 15 minutes prior to cue exposure at lab 2; Placebo lozenge 15 minute prior to cue exposure at lab 3
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
37 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
48.6 years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
48.7 years
STANDARD_DEVIATION 11.6 • n=10 Participants
|
43.1 years
STANDARD_DEVIATION 13.0 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
32 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
8 participants
n=5 Participants
|
10 participants
n=4 Participants
|
9 participants
n=21 Participants
|
9 participants
n=10 Participants
|
56 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: approximately 15 minutesCraving as assessed via the craving question on the Minnesota Nicotine Withdrawal Scale. The score range is from 0 (no craving) to 4 (severe craving). The outcome measure is the change in craving score from before cue exposure to craving score after cue exposure.
Outcome measures
| Measure |
Nicotine Lozenge Prior to Cue Exposure
n=46 Participants
Nicotine lozenge is used 15 minutes prior to smoking cue exposure
Nicotine lozenge 4 mg
|
Placebo Lozenge Prior to Cue Exposure
n=46 Participants
Placebo lozenge is used 15 minutes prior to smoking cue exposure
Placebo lozenge
|
Control Condition: Lozenge After Cue Exposure
n=45 Participants
Lozenge is used immediately after smoking cue exposure
Nicotine lozenge 4 mg
|
|---|---|---|---|
|
Craving Symptom Severity Score Assessed Via Questionnaire
|
0.52 units on a scale
Standard Error 0.13
|
0.57 units on a scale
Standard Error 0.13
|
0.31 units on a scale
Standard Error 0.13
|
PRIMARY outcome
Timeframe: approximately 15 minutesWithdrawal as assessed via the Minnesota Nicotine Withdrawal Scale. The score range is from 0 to 28 with higher scores indicating more severe withdrawal symptoms. The outcome measure is the change in withdrawal score from before cue exposure to the withdrawal score after cue exposure.
Outcome measures
| Measure |
Nicotine Lozenge Prior to Cue Exposure
n=46 Participants
Nicotine lozenge is used 15 minutes prior to smoking cue exposure
Nicotine lozenge 4 mg
|
Placebo Lozenge Prior to Cue Exposure
n=46 Participants
Placebo lozenge is used 15 minutes prior to smoking cue exposure
Placebo lozenge
|
Control Condition: Lozenge After Cue Exposure
n=45 Participants
Lozenge is used immediately after smoking cue exposure
Nicotine lozenge 4 mg
|
|---|---|---|---|
|
Withdrawal Symptom Severity Score Assessed Via Questionnaire
|
1.28 units on a scale
Standard Error 0.39
|
0.96 units on a scale
Standard Error 0.39
|
1.92 units on a scale
Standard Error 0.39
|
Adverse Events
Nicotine Lozenge Prior to Cue Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Lozenge Prior to Cue Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition: Lozenge After Cue Exposure
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
Restriction type: LTE60