Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 12, 2007
September 1, 2011
August 2005
December 2009   (final data collection date for primary outcome measure)
  • ADHD Symptoms [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00573248 on ClinicalTrials.gov Archive Site
Blood Pressure [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches
To examine the behavioral effects of nicotine patches under Aims 1 and 2 in relation to contextual factors. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Nicotine and Behavior in Adult ADHD
Nicotine and Behavioral Regulation in Adult ADHD

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
ADHD
  • Drug: Nicotine

    21 mg nicotine patches for smokers for 2 days

    7 mg nicotine patches for nonsmokers for 2 days

  • Other: Placebo
    Placebo Patch
Experimental: 4
Interventions:
  • Drug: Nicotine
  • Other: Placebo
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.
 
Completed
78
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00573248
2005-4296, TRDRP grant# 14RT-0147H
Yes
University of California, Irvine
University of California, Irvine
Not Provided
Principal Investigator: Jean G Gehricke, Ph.D. University of California, Irvine
University of California, Irvine
September 2011

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