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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

Tracking Information
First Submitted Date  ICMJE December 12, 2007
First Posted Date  ICMJE December 14, 2007
Results First Submitted Date  ICMJE April 1, 2011
Results First Posted Date  ICMJE September 2, 2011
Last Update Posted Date September 9, 2011
Study Start Date  ICMJE August 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
  • ADHD Symptoms [ Time Frame: 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
  • Negative Moods [ Time Frame: 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
  • Side Effects [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
To examine the effects of nicotine and placebo patches on ADHD symptoms, cardiovascular activity, and daily moods in female and male smokers and nonsmokers with ADHD. [ Time Frame: 4 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
Blood Pressure [ Time Frame: 4 days ]
Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
To examine the behavioral effects of nicotine patches under Aims 1 and 2 in relation to contextual factors. [ Time Frame: 4 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nicotine and Behavior in Adult ADHD
Official Title  ICMJE Nicotine and Behavioral Regulation in Adult ADHD
Brief Summary

Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsivity, and hyperactivity that are frequently treated with stimulant medications such as Ritalin. Many people with ADHD smoke. The smoking prevalence rates are estimated to be 40% in adults with ADHD compared to 20% in the general population. People with ADHD have also more difficulty to quit smoking. Only 29% of smokers with ADHD quit smoking compared to 48.5% of smokers in the general population. Nicotine is a stimulant, which may have properties similar to stimulant medications (e.g., Ritalin) used to treat ADHD. Nicotine may increase attention and reduce hyperactivity and impulsivity and, thus, may regulate behavior in individuals with ADHD. Alleviating the symptoms of ADHD and increasing cardiovascular activity through smoking may mimic the effects of stimulant medications and can be a form of self-medication.

The major objective of the study was to examine the effects of nicotine on ADHD symptoms, moods, and cardiovascular activity. The study investigated the effects of nicotine patches on behavioral regulation in adult smokers and nonsmokers with ADHD. Smokers and nonsmokers with ADHD participated in two conditions: (1) nicotine patch and (2) placebo patch. During each condition, symptoms, moods, and side effects were assessed for 2 days during waking hours. An electronic handheld diary, programmed to prompt the participant twice per hour, recorded ADHD symptoms (e.g., difficulty concentrating, impulsivity, etc.), negative moods (e.g., anger, stress), and nicotine side effects (nausea, dizziness). Heart rate and blood pressure were recorded with lightweight ambulatory monitors to indicate cardiovascular activity. Results provided information about the effects of nicotine patches on behavioral regulation in adult smokers and nonsmokers with ADHD.

The inclusion of nonsmokers was important to clarify whether the effects of nicotine on smokers was due to smoking withdrawal. The findings help explain the increased smoking prevalence rates and reduced quit rates associated with ADHD. Knowledge about nicotine's effects on behavioral regulation can help to develop successful smoking cessation programs for individuals with ADHD. The findings on cardiovascular activity may help determine the potential risk for cardiovascular disease in smokers and nonsmokers with ADHD. The study contributed to understanding nicotine's effects on behavioral regulation in a highly vulnerable population such as people with ADHD.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE ADHD
Intervention  ICMJE
  • Drug: Nicotine

    21 mg nicotine patches for smokers for 2 days

    7 mg nicotine patches for nonsmokers for 2 days

  • Other: Placebo
    Placebo Patch
Study Arms  ICMJE Experimental: 4
Interventions:
  • Drug: Nicotine
  • Other: Placebo
Publications * Gehricke JG, Hong N, Whalen CK, Steinhoff K, Wigal TL. Effects of transdermal nicotine on symptoms, moods, and cardiovascular activity in the everyday lives of smokers and nonsmokers with attention-deficit/hyperactivity disorder. Psychol Addict Behav. 2009 Dec;23(4):644-55. doi: 10.1037/a0017441.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2009)
78
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2007)
80
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • An age of 18 to 45 years
  • A history of ADHD
  • Current diagnosis of ADHD according to clinical criteria
  • Being a smoker who smokes at least 10 cigarettes per day with 0.5 mg of nicotine per cigarette; OR
  • Being a nonsmoker who has been abstaining from smoking and other nicotine products for the last 2 years

Exclusion Criteria:

  • Treatment for any chronic illness such as heart disease, irregular heartbeat, high blood pressure, diabetes, skin allergies or skin diseases, including psoriasis or eczema, even if currently controlled by medication
  • Current pregnancy, as measured by a pregnancy test (Clear Blue Easy, Unipath, Bedford, UK), or planning to become pregnant within the next 6 months. These individuals will not be included as the nicotine patch may cause harm to the unborn fetus
  • Nursing mothers, or women who have breastfed within the last 12 months
  • Non-English speaking people, because the majority of measurements used in the study have not been validated in languages other than English
  • Current major depressive episode according to clinical criteria
  • Concurrent psychiatric psychoactive medication within the past 12 months
  • Active substance abuse within the past 12 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00573248
Other Study ID Numbers  ICMJE 2005-4296
TRDRP grant# 14RT-0147H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean G Gehricke, Ph.D. University of California, Irvine
PRS Account University of California, Irvine
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP