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The Reinforcing Mechanisms of Smoking in Adult ADHD

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ClinicalTrials.gov Identifier: NCT00573859
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : November 7, 2011
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

Study Description
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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.


Condition or disease Intervention/treatment Phase
ADHD Drug: ADHD medication Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Reinforcing Mechanisms of Smoking in Adult ADHD
Study Start Date : September 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Experimental: ADHD medication versus placebo
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
For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.
Other Names:
  • Dextroamphetamine
  • Amphetamine mixed salts
  • Atomoxetine
  • O-Methylphenidate
  • Lisdexamfetamine

Drug: Placebo
For the placebo condition, participants received placebo pills for two consecutive days.


Outcome Measures
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Primary Outcome Measures :
  1. The Effects of ADHD Medication Versus Placebo on Cotinine Levels [ Time Frame: 4 days ]
    Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.


Secondary Outcome Measures :
  1. The Interacting Effects of Smoking and Overnight Abstinence With ADHD Medication and Placebo on Continuous Performance Task (CPT) Errors of Omission. [ Time Frame: 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.

  2. The Interacting Effects of Smoking and Abstinence With ADHD Medication and Placebo on Nicotine Withdrawal Measured by the Shiffman-Jarvik Withdrawal Questionnaire. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573859


Locations
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United States, California
Department of Pediatrics
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Jean G Gehricke, Ph.D. University of California, Irvine
More Information
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Publications of Results:

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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573859     History of Changes
Other Study ID Numbers: 2006-5156
NIH grant# DA018752
First Posted: December 14, 2007    Key Record Dates
Results First Posted: November 7, 2011
Last Update Posted: November 7, 2011
Last Verified: September 2011
Keywords provided by University of California, Irvine:
Smoking
ADHD
Stimulant medication
Additional relevant MeSH terms:
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Methylphenidate
Amphetamine
Lisdexamfetamine Dimesylate
Dextroamphetamine
Atomoxetine Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents