The Reinforcing Mechanisms of Smoking in Adult ADHD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00573859
First received: December 12, 2007
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
ADHD
Drug: ADHD medication
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Reinforcing Mechanisms of Smoking in Adult ADHD

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • The Effects of ADHD Medication Versus Placebo on Cotinine Levels [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Salivary cotinine was measured across two days on ADHD medication versus two days on placebo.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: September 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573859

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

Publications:
Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573859     History of Changes
Other Study ID Numbers: 2006-5156, NIH grant# DA018752
Study First Received: December 12, 2007
Results First Received: August 15, 2011
Last Updated: September 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Smoking
ADHD
Stimulant medication

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Amphetamine
Dextroamphetamine
Methylphenidate
Atomoxetine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014