Trial Outcomes & Findings for Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms (NCT NCT01522963)

Last Updated: 2017-08-21

Results Overview

The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges.

Recruitment status

COMPLETED

Study phase

Target enrollment

98 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2017-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Nicotine Lozenge Immediately Prior to Stress Task. Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 10 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 20 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 30 Min Prior to Stress Task Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
Overall Study STARTED	24	25	25	24
Overall Study COMPLETED	22	22	22	18
Overall Study NOT COMPLETED	2	3	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nicotine Lozenge Immediately Prior to Stress Task. n=22 Participants Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 10 Min Prior to Stress Task n=22 Participants Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 20 Min Prior to Stress Task n=22 Participants Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 30 Min Prior to Stress Task n=18 Participants Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Total n=84 Participants Total of all reporting groups
Age, Continuous	37.2 years STANDARD_DEVIATION 10.6 • n=5 Participants	39.7 years STANDARD_DEVIATION 10.9 • n=7 Participants	38.1 years STANDARD_DEVIATION 16.2 • n=5 Participants	37.9 years STANDARD_DEVIATION 14.1 • n=4 Participants	38.3 years STANDARD_DEVIATION 12.9 • n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants	9 Participants n=4 Participants	41 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	43 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 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
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	20 Participants n=21 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants	14 Participants n=4 Participants	55 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United States	22 participants n=5 Participants	22 participants n=7 Participants	22 participants n=5 Participants	18 participants n=4 Participants	84 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months

Outcome measures

Outcome measures
Measure	Nicotine Lozenge Immediately Prior to Stress Task. n=22 Participants Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 10 Min Prior to Stress Task n=22 Participants Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 20 Min Prior to Stress Task n=22 Participants Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 30 Min Prior to Stress Task n=18 Participants Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
Craving	5.17 units on a scale Interval 2.43 to 7.91	2.45 units on a scale Interval 0.29 to 4.61	-1.05 units on a scale Interval -3.6 to 1.51	-1.34 units on a scale Interval -4.09 to 1.4

PRIMARY outcome

Timeframe: 5 to 35 minutes

The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity.

Outcome measures

Outcome measures
Measure	Nicotine Lozenge Immediately Prior to Stress Task. n=22 Participants Subjects receive the 4 mg nicotine lozenge immediately prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 10 Min Prior to Stress Task n=22 Participants Subjects receive the 4 mg nicotine lozenge 10 minutes prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 20 Min Prior to Stress Task n=22 Participants Subjects receive the 4 mg nicotine lozenge 20 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session	Nicotine Lozenge 30 Min Prior to Stress Task n=18 Participants Subjects receive the 4 mg nicotine lozenge 30 min prior to the stress task at one laboratory session and after the stress task at the other laboratory session
Nicotine Withdrawal Symptoms	2.1 units on a scale Interval 0.23 to 3.98	2.18 units on a scale Interval 0.07 to 4.29	0.32 units on a scale Interval -1.88 to 2.51	0.16 units on a scale Interval -1.95 to 2.28

Adverse Events

Nicotine Lozenge Prior to Stress Task

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nicotine Lozenge After Stress Task

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

Michael Kotlyar

University of Minnesota

Phone: 6126251160

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place