The Reinforcing Mechanisms of Smoking in Adult ADHD

Study Overview
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Brief Summary
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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.

Official Title
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The Reinforcing Mechanisms of Smoking in Adult ADHD

Conditions
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ADHD

Intervention / Treatment
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* Drug: ADHD medication
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADHD medication versus placebo<br>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. | Drug: ADHD medication<br>* For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.<br>* Other names: Lisdexamfetamine;Drug: Placebo<br>* For the placebo condition, participants received placebo pills for two consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, ADHD, Stimulant medication