Trial Outcomes & Findings for Nicotine and Behavior in Adult ADHD (NCT NCT00573248)

NCT ID: NCT00573248

Last Updated: 2011-09-09

Results Overview

Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2011-09-09

Participant Flow

Participant milestones

Measure	Smokers In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.	Nonsmokers In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
Overall Study STARTED	40	38
Overall Study Nicotine Patches and Placebo Patches	25	27
Overall Study COMPLETED	25	27
Overall Study NOT COMPLETED	15	11

Reasons for withdrawal

Measure	Smokers In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.	Nonsmokers In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
Overall Study scheduling conflicts	15	11

Baseline Characteristics

Nicotine and Behavior in Adult ADHD

Baseline characteristics by cohort

Measure	Smokers n=40 Participants In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.	Nonsmokers n=38 Participants In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.	Total n=78 Participants Total of all reporting groups
Region of Enrollment United States	40 participants n=5 Participants	38 participants n=7 Participants	78 participants n=5 Participants
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	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	25 years STANDARD_DEVIATION 7 • n=5 Participants	28 years STANDARD_DEVIATION 8 • n=7 Participants	27 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	25 Participants n=7 Participants	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

Population: Per protocol, average ADHD symptoms, cardiovascular activity and moods during nicotine compared to placebo.

Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches

Outcome measures

Measure	Nicotine Patches n=52 Participants Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.	Placebo Patches n=52 Participants Smokers and nonsmokers received placebo patches for two consecutive days.
ADHD Symptoms Difficulty concentrating	71.2 Percent of item endorsement Standard Error 4.0	78.4 Percent of item endorsement Standard Error 3.4
ADHD Symptoms Forgetfulness	47.4 Percent of item endorsement Standard Error 4.0	55.5 Percent of item endorsement Standard Error 4.4
ADHD Symptoms Restlessness	71.8 Percent of item endorsement Standard Error 3.9	78.5 Percent of item endorsement Standard Error 3.2
ADHD Symptoms Impatience	72.3 Percent of item endorsement Standard Error 4.2	79.4 Percent of item endorsement Standard Error 3.7
ADHD Symptoms Impulsivity	61.8 Percent of item endorsement Standard Error 4.7	71.5 Percent of item endorsement Standard Error 3.9

PRIMARY outcome

Timeframe: 4 days

Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches

Outcome measures

Measure	Nicotine Patches n=52 Participants Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.	Placebo Patches n=52 Participants Smokers and nonsmokers received placebo patches for two consecutive days.
Negative Moods Anger	60.0 Percent of item endorsement Standard Error 4.5	71.4 Percent of item endorsement Standard Error 4.1
Negative Moods Nervousness	69.7 Percent of item endorsement Standard Error 4.1	77.1 Percent of item endorsement Standard Error 3.4
Negative Moods Stress	66.9 Percent of item endorsement Standard Error 4.4	74.2 Percent of item endorsement Standard Error 3.9

PRIMARY outcome

Timeframe: 4 days

Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches

Outcome measures

Measure	Nicotine Patches n=52 Participants Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.	Placebo Patches n=52 Participants Smokers and nonsmokers received placebo patches for two consecutive days.
Side Effects Nausea	37.7 Percent of item endorsement Standard Error 3.5	30.7 Percent of item endorsement Standard Error 3.6
Side Effects Dizziness	33.5 Percent of item endorsement Standard Error 3.2	33.8 Percent of item endorsement Standard Error 3.5

SECONDARY outcome

Timeframe: 4 days

Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches

Outcome measures

Measure	Nicotine Patches n=52 Participants Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.	Placebo Patches n=52 Participants Smokers and nonsmokers received placebo patches for two consecutive days.
Blood Pressure Systolic Blood Pressure	134 mm HG Standard Deviation 17	131 mm HG Standard Deviation 16
Blood Pressure Diastolic Blood Pressure	81 mm HG Standard Deviation 11	78 mm HG Standard Deviation 12

Adverse Events

Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nonsmokers

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

Jean Gehricke, Ph.D.

University of California, Irvine

Phone: 949-824-1834

Email: jgehrick@uci.edu

Results disclosure agreements

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