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Nicotine and Behavior in Adult ADHD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00573248
First received: December 12, 2007
Last updated: September 1, 2011
Last verified: September 2011
History of Changes
Results First Received: April 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: ADHD
Interventions: Drug: Nicotine
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Smokers     Nonsmokers  
STARTED     40     38  
Nicotine Patches and Placebo Patches     25     27  
COMPLETED     25     27  
NOT COMPLETED     15     11  
scheduling conflicts                 15                 11  



  Baseline Characteristics
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Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Smokers     Nonsmokers     Total  
Number of Participants  
[units: participants]
 		  40     38     78  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     40     38     78  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  25  ± 7     28  ± 8     27  ± 8  
Gender  
[units: participants]
 		     
Female     9     13     22  
Male     31     25     56  
Region of Enrollment  
[units: participants]
 		     
United States     40     38     78  



  Outcome Measures
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1.  Primary:   ADHD Symptoms   [ Time Frame: 4 days ]
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2.  Primary:   Negative Moods   [ Time Frame: 4 days ]
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3.  Primary:   Side Effects   [ Time Frame: 4 days ]
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4.  Secondary:   Blood Pressure   [ Time Frame: 4 days ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Jean Gehricke, Ph.D.
Organization: University of California, Irvine
phone: 949-824-1834
e-mail: jgehrick@uci.edu


Publications of Results:


Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573248     History of Changes
Other Study ID Numbers: 2005-4296, TRDRP grant# 14RT-0147H
Study First Received: December 12, 2007
Results First Received: April 1, 2011
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board