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Nicotine and Behavior in Adult ADHD

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ClinicalTrials.gov Identifier: NCT00573248
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : September 2, 2011
Last Update Posted : September 9, 2011
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition ADHD
Interventions Drug: Nicotine
Other: Placebo
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Smokers Nonsmokers
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 40 38
Nicotine Patches and Placebo Patches 25 27
Completed 25 27
Not Completed 15 11
Reason Not Completed
scheduling conflicts             15             11
Arm/Group Title Smokers Nonsmokers Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 40 38 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 38 participants 78 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
38
 100.0%
78
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 38 participants 78 participants
25  (7) 28  (8) 27  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 38 participants 78 participants
Female
9
  22.5%
13
  34.2%
22
  28.2%
Male
31
  77.5%
25
  65.8%
56
  71.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 38 participants 78 participants
40 38 78
1.Primary Outcome
Title ADHD Symptoms
Hide Description 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
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, average ADHD symptoms, cardiovascular activity and moods during nicotine compared to placebo.
Arm/Group Title Nicotine Patches Placebo Patches
Hide Arm/Group Description:
Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
Smokers and nonsmokers received placebo patches for two consecutive days.
Overall Number of Participants Analyzed 52 52
Mean (Standard Error)
Unit of Measure: Percent of item endorsement
Difficulty concentrating 71.2  (4.0) 78.4  (3.4)
Forgetfulness 47.4  (4.0) 55.5  (4.4)
Restlessness 71.8  (3.9) 78.5  (3.2)
Impatience 72.3  (4.2) 79.4  (3.7)
Impulsivity 61.8  (4.7) 71.5  (3.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Patches, Placebo Patches
Comments 2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.025
Comments Adjusted for multiple comparisons
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Negative Moods
Hide Description 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
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Patches Placebo Patches
Hide Arm/Group Description:
Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
Smokers and nonsmokers received placebo patches for two consecutive days.
Overall Number of Participants Analyzed 52 52
Mean (Standard Error)
Unit of Measure: Percent of item endorsement
Anger 60.0  (4.5) 71.4  (4.1)
Nervousness 69.7  (4.1) 77.1  (3.4)
Stress 66.9  (4.4) 74.2  (3.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Patches, Placebo Patches
Comments 2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.025
Comments Adjusted for multiple comparisons
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Side Effects
Hide Description 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
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Patches Placebo Patches
Hide Arm/Group Description:
Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
Smokers and nonsmokers received placebo patches for two consecutive days.
Overall Number of Participants Analyzed 52 52
Mean (Standard Error)
Unit of Measure: Percent of item endorsement
Nausea 37.7  (3.5) 30.7  (3.6)
Dizziness 33.5  (3.2) 33.8  (3.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Patches, Placebo Patches
Comments 2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.025
Comments Adjusted for multiple comparisons
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Blood Pressure
Hide Description Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nicotine Patches Placebo Patches
Hide Arm/Group Description:
Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
Smokers and nonsmokers received placebo patches for two consecutive days.
Overall Number of Participants Analyzed 52 52
Mean (Standard Deviation)
Unit of Measure: mm HG
Systolic Blood Pressure 134  (17) 131  (16)
Diastolic Blood Pressure 81  (11) 78  (12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nicotine Patches, Placebo Patches
Comments 2 (nicotine versus placebo) x 2 (smoker versus nonsmoker) ANOVA
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.025
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Smokers Nonsmokers
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Smokers Nonsmokers
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Smokers Nonsmokers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/27 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Smokers Nonsmokers
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/27 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jean Gehricke, Ph.D.
Organization: University of California, Irvine
Phone: 949-824-1834
EMail: jgehrick@uci.edu
Layout table for additonal information
Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573248    
Other Study ID Numbers: 2005-4296
TRDRP grant# 14RT-0147H
First Submitted: December 12, 2007
First Posted: December 14, 2007
Results First Submitted: April 1, 2011
Results First Posted: September 2, 2011
Last Update Posted: September 9, 2011