Trial Outcomes & Findings for Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes (NCT NCT00960778)

Last Updated: 2018-10-23

Results Overview

Participants will complete cue exposure sessions after 3 days of nicotine patch use and rate craving on a 10 item self-report questionnaire. The Within Sessions Rating scale measures craving with 0 indicating Not at All and 10 indicating Extremely.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Day 3

Results posted on

2018-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Nicotine- Dependent Women Over a period of one week, nicotine-dependent women completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.	Nicotine- Dependent Men Over a period of one week, nicotine-dependent men completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
Overall Study STARTED	17	16
Overall Study COMPLETED	8	13
Overall Study NOT COMPLETED	9	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nicotine- Dependent Women n=17 Participants Over a period of one week, nicotine-dependent women completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.	Nicotine- Dependent Men n=16 Participants Over a period of one week, nicotine-dependent men completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.	Total n=33 Participants Total of all reporting groups
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	17 Participants n=5 Participants	16 Participants n=7 Participants	33 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	17 Participants n=5 Participants	0 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 3

Population: 12 women and 15 men completed the 3 days of Nictoine Replacement Therapy and completed the second scan.

Outcome measures

Outcome measures
Measure	Nicotine- Dependent Women n=12 Participants Over a period of one week, nicotine-dependent women completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.	Nicotine- Dependent Men n=15 Participants Over a period of one week, nicotine-dependent men completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
Post- Cue Exposure Craving Nicotine Patch	25.58 score on a scale Standard Deviation 14.82	25.6 score on a scale Standard Deviation 12.6

PRIMARY outcome

Timeframe: Day 7

Population: 8 women and 13 men complete the 4 days of denicotinized cigarette use and completed the third scan.

Participants will complete cue exposure sessions after 4 days of denicotinized cigarette us and rate craving on a 10 item self-report questionnaire, the Questionnaire of Smoking Urges- Brief (QSU-B). Participants rate craving on a scale on a 1-7 point Likert scale where indicates Strongly Disagree and 7 indicates Strongly Agree. Higher scores indicate higher craving. Ratings from the 10 items are summed to attain the score reported here.

Outcome measures

Outcome measures
Measure	Nicotine- Dependent Women n=8 Participants Over a period of one week, nicotine-dependent women completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.	Nicotine- Dependent Men n=13 Participants Over a period of one week, nicotine-dependent men completed 3 scans while being shown smoking related cues. Participants completed a baseline scan, a scan following 3 days of Nicotine Replacement Therapy (21 mg nicotine patch), and one following 4 days of denicotinized cigarette use.
Post- Cue Exposure Craving Denicotinized Cigarettes	22.13 score on a scale Standard Deviation 14.38	17.85 score on a scale Standard Deviation 9.21

Adverse Events

Nicotine- Dependent Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nicotine- Dependent Men

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

Dr. Karen Hartwell

Medical University of South Carolina

Phone: 843-792-8174

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place