Nicotine and Behavior in Adult ADHD
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for ADHD focused on measuring Nicotine, ADHD, Gender
Eligibility Criteria
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
Sites / Locations
- Department of Pediatrics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
4
Arm Description
Outcomes
Primary Outcome Measures
ADHD Symptoms
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
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
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
Secondary Outcome Measures
Blood Pressure
Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches
Full Information
NCT ID
NCT00573248
First Posted
December 12, 2007
Last Updated
September 1, 2011
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT00573248
Brief Title
Nicotine and Behavior in Adult ADHD
Official Title
Nicotine and Behavioral Regulation in Adult ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
Nicotine, ADHD, Gender
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nicotine
Intervention Description
21 mg nicotine patches for smokers for 2 days
7 mg nicotine patches for nonsmokers for 2 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo Patch
Primary Outcome Measure Information:
Title
ADHD Symptoms
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
Title
Negative Moods
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
Title
Side Effects
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
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean G Gehricke, Ph.D.
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20025370
Citation
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.
Results Reference
result
Learn more about this trial
Nicotine and Behavior in Adult ADHD
We'll reach out to this number within 24 hrs