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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
Results First Received: April 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Participant, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

1.  Primary:   ADHD Symptoms   [ Time Frame: 4 days ]

2.  Primary:   Negative Moods   [ Time Frame: 4 days ]

3.  Primary:   Side Effects   [ Time Frame: 4 days ]

4.  Secondary:   Blood Pressure   [ Time Frame: 4 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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