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Trial Outcomes & Findings for Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3 (NCT NCT00390559)

NCT ID: NCT00390559

Last Updated: 2012-07-18

Results Overview

The full scale name is the "Urge to smoke" visual analog scale (VAS). It measures self-reported "urge to smoke". As with any VAS a word or phrase (in this case, "Urge to Smoke" is centered over a horizontal line anchored on the left by "not at all" and on the right by "extremely." In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 ("not at all") and the maximum score was 100 ("extremely").

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

6 hours

Results posted on

2012-07-18

Participant Flow

Recruitment via media advertisement and flyer. Recruitment began 9/14/2005 and ended 1/30/2008.

Enrolled (i.e., consented) participants were excluded if they failed to meet safety criteria (e.g., blood pressure) measured after the informed consent was given.

Participant milestones

Participant milestones
Measure
All Participants
In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing \[NIC\] or not \[DENIC\]). Cigarettes were smoked 4 hours after TN administration.
Overall Study
STARTED
124
Overall Study
Received PlaceboP/Active C
93
Overall Study
ActiveP/ActiveC
87
Overall Study
PlaceboP/PlaceboC
93
Overall Study
ActiveP/PlaceboC
90
Overall Study
COMPLETED
80
Overall Study
NOT COMPLETED
44

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=124 Participants
In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing \[NIC\] or not \[DENIC\]). Cigarettes were smoked 4 hours after TN administration.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
124 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
42 Participants
n=5 Participants
Sex: Female, Male
Male
82 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: Those who completed all four "arms" of the crossover study.

The full scale name is the "Urge to smoke" visual analog scale (VAS). It measures self-reported "urge to smoke". As with any VAS a word or phrase (in this case, "Urge to Smoke" is centered over a horizontal line anchored on the left by "not at all" and on the right by "extremely." In this study, participants used a mouse to produce a vertical mark on the horizontal line, and the score was the distance of the mark from the left anchor expressed as a percentage of total line length. Thus, the minimum was 0 ("not at all") and the maximum score was 100 ("extremely").

Outcome measures

Outcome measures
Measure
ActiveP/ActiveC
n=80 Participants
21 mg patch/Nicotine-containing cigarette
PlaceboP/ActiveC
n=80 Participants
0 mg patch/nicotine-containing cigarette
Active P/PlaceboC
n=80 Participants
21 mg patch/no nicotine cigarette
PlaceboP/PlaceboC
n=80 Participants
0 mg patch/no nicotine cigarette
Subjective Effects
18.8 units on a scale
Standard Deviation 24.7
23.1 units on a scale
Standard Deviation 24.5
25.6 units on a scale
Standard Deviation 28.8
24.2 units on a scale
Standard Deviation 25.8

Adverse Events

ActiveP/ActiveC

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

PlaceboP/ActiveC

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Active P/PlaceboC

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

PlaceboP/PlaceboC

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

Thomas Eissenberg

Virginia Commonwealth University

Phone: 804.827.4617

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place