Nicotine and Behavior in Adult ADHD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00573248
First received: December 12, 2007
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

Attention deficit hyperactivity disorder (ADHD) is characterized by inattention, impulsivity, and hyperactivity that are frequently treated with stimulant medications such as Ritalin. Many people with ADHD smoke. The smoking prevalence rates are estimated to be 40% in adults with ADHD compared to 20% in the general population. People with ADHD have also more difficulty to quit smoking. Only 29% of smokers with ADHD quit smoking compared to 48.5% of smokers in the general population. Nicotine is a stimulant, which may have properties similar to stimulant medications (e.g., Ritalin) used to treat ADHD. Nicotine may increase attention and reduce hyperactivity and impulsivity and, thus, may regulate behavior in individuals with ADHD. Alleviating the symptoms of ADHD and increasing cardiovascular activity through smoking may mimic the effects of stimulant medications and can be a form of self-medication.

The major objective of the study was to examine the effects of nicotine on ADHD symptoms, moods, and cardiovascular activity. The study investigated the effects of nicotine patches on behavioral regulation in adult smokers and nonsmokers with ADHD. Smokers and nonsmokers with ADHD participated in two conditions: (1) nicotine patch and (2) placebo patch. During each condition, symptoms, moods, and side effects were assessed for 2 days during waking hours. An electronic handheld diary, programmed to prompt the participant twice per hour, recorded ADHD symptoms (e.g., difficulty concentrating, impulsivity, etc.), negative moods (e.g., anger, stress), and nicotine side effects (nausea, dizziness). Heart rate and blood pressure were recorded with lightweight ambulatory monitors to indicate cardiovascular activity. Results provided information about the effects of nicotine patches on behavioral regulation in adult smokers and nonsmokers with ADHD.

The inclusion of nonsmokers was important to clarify whether the effects of nicotine on smokers was due to smoking withdrawal. The findings help explain the increased smoking prevalence rates and reduced quit rates associated with ADHD. Knowledge about nicotine's effects on behavioral regulation can help to develop successful smoking cessation programs for individuals with ADHD. The findings on cardiovascular activity may help determine the potential risk for cardiovascular disease in smokers and nonsmokers with ADHD. The study contributed to understanding nicotine's effects on behavioral regulation in a highly vulnerable population such as people with ADHD.


Condition Intervention
ADHD
Drug: Nicotine
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Nicotine and Behavioral Regulation in Adult ADHD

Resource links provided by NLM:


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

Primary Outcome Measures:
  • ADHD Symptoms [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches

  • Negative Moods [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches

  • Side Effects [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    Mean percentage of endorsement for each electronic diary item (percent of 'yes' on an item) during 2 days on nicotine patches versus 2 days placebo patches


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches


Enrollment: 78
Study Start Date: August 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4 Drug: Nicotine

21 mg nicotine patches for smokers for 2 days

7 mg nicotine patches for nonsmokers for 2 days

Other: Placebo
Placebo Patch

  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
  • Being a smoker who smokes at least 10 cigarettes per day with 0.5 mg of nicotine per cigarette; OR
  • Being a nonsmoker who has been abstaining from smoking and other nicotine products for the last 2 years

Exclusion Criteria:

  • Treatment for any chronic illness such as heart disease, irregular heartbeat, high blood pressure, diabetes, skin allergies or skin diseases, including psoriasis or eczema, 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 as the nicotine patch may cause harm to the unborn fetus
  • Nursing mothers, or women who have breastfed within the last 12 months
  • Non-English speaking people, because the majority of measurements used in the study have not been validated in languages other than English
  • Current major depressive episode according to clinical criteria
  • Concurrent psychiatric psychoactive medication within the past 12 months
  • Active substance abuse within the past 12 months
  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: NCT00573248

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: NCT00573248     History of Changes
Other Study ID Numbers: 2005-4296, TRDRP grant# 14RT-0147H
Study First Received: December 12, 2007
Results First Received: April 1, 2011
Last Updated: September 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Nicotine
ADHD
Gender

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014