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| ID | Type | Description | Link |
|---|---|---|---|
| TRDRP grant# 14RT-0147H |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Drug | 21 mg nicotine patches for smokers for 2 days 7 mg nicotine patches for nonsmokers for 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 days |
| 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 | 4 days |
| 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 | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean G Gehricke, Ph.D. | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics | Irvine | California | 92612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20025370 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Nonsmokers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Per protocol, average ADHD symptoms, cardiovascular activity and moods during nicotine compared to placebo. | Posted | Apr 2011 | Mean | Standard Error | Percent of item endorsement | 4 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean Gehricke, Ph.D. | University of California, Irvine | 949-824-1834 | jgehrick@uci.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012725 | Sexual Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Placebo | Other | Placebo Patch |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Blood Pressure | Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches | Posted | May 2011 | Mean | Standard Deviation | mm HG | 4 days |
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| Primary | 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 | Posted | May 2011 | Mean | Standard Error | Percent of item endorsement | 4 days |
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| Primary | 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 | Posted | May 2011 | Mean | Standard Error | Percent of item endorsement | 4 days |
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| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 27 | 0 | 27 |
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| D001519 | Behavior |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| Stress |
|