ADHD
Conditions
Keywords
Nicotine, ADHD, Gender
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.
Interventions
DRUGNicotine
21 mg nicotine patches for smokers for 2 days 7 mg nicotine patches for nonsmokers for 2 days
OTHERPlacebo
Placebo Patch
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADHD Symptoms | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 4 days | Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 38 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | scheduling conflicts | 15 | 11 |
Baseline characteristics
| Characteristic | Nonsmokers | Smokers | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 40 Participants | 78 Participants |
| Age Continuous | 28 years STANDARD_DEVIATION 8 | 25 years STANDARD_DEVIATION 7 | 27 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 38 participants | 40 participants | 78 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 25 Participants | 31 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
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
Time frame: 4 days
Population: Per protocol, average ADHD symptoms, cardiovascular activity and moods during nicotine compared to placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patches | ADHD Symptoms | Forgetfulness | 47.4 Percent of item endorsement | Standard Error 4 |
| Nicotine Patches | ADHD Symptoms | Impatience | 72.3 Percent of item endorsement | Standard Error 4.2 |
| Nicotine Patches | ADHD Symptoms | Restlessness | 71.8 Percent of item endorsement | Standard Error 3.9 |
| Nicotine Patches | ADHD Symptoms | Impulsivity | 61.8 Percent of item endorsement | Standard Error 4.7 |
| Nicotine Patches | ADHD Symptoms | Difficulty concentrating | 71.2 Percent of item endorsement | Standard Error 4 |
| Placebo Patches | ADHD Symptoms | Impulsivity | 71.5 Percent of item endorsement | Standard Error 3.9 |
| Placebo Patches | ADHD Symptoms | Difficulty concentrating | 78.4 Percent of item endorsement | Standard Error 3.4 |
| Placebo Patches | ADHD Symptoms | Forgetfulness | 55.5 Percent of item endorsement | Standard Error 4.4 |
| Placebo Patches | ADHD Symptoms | Restlessness | 78.5 Percent of item endorsement | Standard Error 3.2 |
| Placebo Patches | ADHD Symptoms | Impatience | 79.4 Percent of item endorsement | Standard Error 3.7 |
Comparison: 2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary itemp-value: <0.025ANOVA
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
Time frame: 4 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patches | Negative Moods | Anger | 60.0 Percent of item endorsement | Standard Error 4.5 |
| Nicotine Patches | Negative Moods | Nervousness | 69.7 Percent of item endorsement | Standard Error 4.1 |
| Nicotine Patches | Negative Moods | Stress | 66.9 Percent of item endorsement | Standard Error 4.4 |
| Placebo Patches | Negative Moods | Anger | 71.4 Percent of item endorsement | Standard Error 4.1 |
| Placebo Patches | Negative Moods | Nervousness | 77.1 Percent of item endorsement | Standard Error 3.4 |
| Placebo Patches | Negative Moods | Stress | 74.2 Percent of item endorsement | Standard Error 3.9 |
Comparison: 2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary itemp-value: <0.025ANOVA
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
Time frame: 4 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patches | Side Effects | Nausea | 37.7 Percent of item endorsement | Standard Error 3.5 |
| Nicotine Patches | Side Effects | Dizziness | 33.5 Percent of item endorsement | Standard Error 3.2 |
| Placebo Patches | Side Effects | Nausea | 30.7 Percent of item endorsement | Standard Error 3.6 |
| Placebo Patches | Side Effects | Dizziness | 33.8 Percent of item endorsement | Standard Error 3.5 |
Comparison: 2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary itemp-value: <0.025ANOVA
Secondary
Blood Pressure
Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches
Time frame: 4 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nicotine Patches | Blood Pressure | Systolic Blood Pressure | 134 mm HG | Standard Deviation 17 |
| Nicotine Patches | Blood Pressure | Diastolic Blood Pressure | 81 mm HG | Standard Deviation 11 |
| Placebo Patches | Blood Pressure | Systolic Blood Pressure | 131 mm HG | Standard Deviation 16 |
| Placebo Patches | Blood Pressure | Diastolic Blood Pressure | 78 mm HG | Standard Deviation 12 |
Comparison: 2 (nicotine versus placebo) x 2 (smoker versus nonsmoker) ANOVAp-value: <0.025ANOVA