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| ID | Type | Description | Link |
|---|---|---|---|
| NIH grant# DA018752 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHD medication versus placebo | Experimental | For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication (e.g., Dextroamphetamine; Amphetamine mixed salts; Atomoxetine; O-Methylphenidate; Lisdexamfetamine). For the placebo condition, a placebo pill was administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADHD medication | Drug | For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
|---|---|---|---|
| 21356232 | Result | Gehricke JG, Hong N, Wigal TL, Chan V, Doan A. ADHD medication reduces cotinine levels and withdrawal in smokers with ADHD. Pharmacol Biochem Behav. 2011 May;98(3):485-91. doi: 10.1016/j.pbb.2011.02.021. Epub 2011 Feb 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medication Versus Placebo |
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| ||||||||||||||||||
| Smoking Versus Abstinence |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | Smokers with ADHD | Posted | Mean | Standard Error | ng/ml | 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 | 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. |
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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 |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000069445 | Atomoxetine Hydrochloride |
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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| Placebo | Drug | For the placebo condition, participants received placebo pills for two consecutive days. |
|
| 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. | 4 days |
|
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 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. | Posted | Mean | Standard Error | errors | 4 days |
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| 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. | Posted | Median | Full Range | scores on a scale | 4 days |
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| 0 |
| 27 |
| 0 |
| 27 |
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| D000588 |
| Amines |
| D009930 | Organic Chemicals |
| D011437 | Propylamines |
| Title | Measurements |
|---|---|
|
| Placebo + Abstinence |
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| Placebo + Abstinence |
|