ADHD
Conditions
Keywords
Smoking, ADHD, Stimulant medication
Brief summary
Whereas the smoking prevalence rates in the general population are declining, rates among people diagnosed with attention-deficit hyperactivity disorder (ADHD) continue to be elevated. Smoking may be a form of self-medication in people with ADHD, which has specific reinforcing mechanisms such as improvement of ADHD core symptoms, enhancement of moods and arousal, or a combination of both. In addition, the reinforcing effects of smoking may be potentiated by stimulant medication. The study examined the reinforcing effects of ad libitum smoking with and without ADHD medication in adult smokers with clinically diagnosed ADHD. Participants were adults with ADHD. The effects of two day of ADHD medication compared to two days on placebo for were studied on nicotine intake (i.e., cotinine levels). In addition, task performance on the Continuous Performance Task and nicotine withdrawal symptoms were examined in response to ADHD medication + smoking a cigarette versus ADHD medication + abstinence versus placebo medication + smoking versus placebo medication + abstinence. The study identified the reinforcing mechanisms of smoking in interaction with ADHD medication. The findings will contribute to a better understanding of nicotine addiction and facilitate the development of targeted smoking cessation and prevention programs for individuals with ADHD and other people with deficiencies in impulse control and excessive risk taking.
Interventions
DRUGADHD medication
For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.
DRUGPlacebo
For the placebo condition, participants received placebo pills for two consecutive days.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
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 * Current treatment with stimulant medication * Smoking of 10 cigarettes or more per day
Exclusion criteria
* Treatment for any major medical illness such as cancer, heart disease, diabetes, skin diseases, current major depressive episode, and schizophrenia 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 because smoking may cause harm to the unborn fetus * Nursing mothers * Non-English speaking people, because the majority of measurements used in the study have not been validated in languages other than English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effects of ADHD Medication Versus Placebo on Cotinine Levels | 4 days | Salivary cotinine was measured across two days on ADHD medication versus two days on placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. | 4 days | In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT. |
| The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. | 4 days | The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ADHD Medication Versus Placebo Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Medication Versus Placebo | Scheduling conflicts | 12 |
| Smoking Versus Abstinence | Scheduling conflicts | 12 |
Baseline characteristics
| Characteristic | ADHD Medication Versus Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age Continuous | 27.2 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
The Effects of ADHD Medication Versus Placebo on Cotinine Levels
Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.
Time frame: 4 days
Population: Smokers with ADHD
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADHD Medication Versus Placebo | The Effects of ADHD Medication Versus Placebo on Cotinine Levels | ADHD medication | 180.7 ng/ml | Standard Error 33.3 |
| ADHD Medication Versus Placebo | The Effects of ADHD Medication Versus Placebo on Cotinine Levels | Placebo | 274.0 ng/ml | Standard Error 70.4 |
Comparison: A 2 (ADHD medication versus Placebo) repeated measure ANOVAp-value: <0.05ANOVA
Secondary
The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire.
The Shiffman-Jarvik withdrawal questionnaire measures nicotine withdrawal and was completed after each CPT assessment. The questionnaire consists of 25 items using 8-point scales. Total scores range from 0 to 200 and higher scores reflect higher levels of nicotine withdrawal.
Time frame: 4 days
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| ADHD Medication Versus Placebo | The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. | ADHD medication + Smoking | 92.7 scores on a scale | Full Range 2.9 |
| ADHD Medication Versus Placebo | The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. | ADHD medication + Abstinence | 91.3 scores on a scale | Full Range 3.5 |
| ADHD Medication Versus Placebo | The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. | Placebo + Smoking | 97.0 scores on a scale | Full Range 4.8 |
| ADHD Medication Versus Placebo | The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. | Placebo + Abstinence | 102.0 scores on a scale | Full Range 4.8 |
Comparison: Friedman's two-way analysis of variance by ranks.p-value: <0.05Friedman's two analysis of ranks
Secondary
The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission.
In the morning of each monitoring day, approximately 60 minutes after medication or placebo pill administration, participants were asked to either abstain from smoking or smoke their first cigarette of the day 5 minutes prior to starting the CPT.
Time frame: 4 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADHD Medication Versus Placebo | The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. | ADHD medication + Abstinence | 1.08 errors | Standard Error 0.3 |
| ADHD Medication Versus Placebo | The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. | Placebo + Smoking | 1.00 errors | Standard Error 0.4 |
| ADHD Medication Versus Placebo | The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. | Placebo + Abstinence | 2.8 errors | Standard Error 0.6 |
| ADHD Medication Versus Placebo | The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. | ADHD medication + Smoking | 0.40 errors | Standard Error 0.1 |
Comparison: Four-way repeated measure ANOVAp-value: <0.05ANOVA