Nicotine and Behavior in Adult ADHD

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ClinicalTrials.gov Identifier: NCT00573248

Recruitment Status : Completed

First Posted : December 14, 2007

Results First Posted : September 2, 2011

Last Update Posted : September 9, 2011

Sponsor:

Information provided by (Responsible Party):

University of California, Irvine

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
ADHD	Drug: Nicotine Other: Placebo	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	78 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Basic Science
Official Title:	Nicotine and Behavioral Regulation in Adult ADHD
Study Start Date :	August 2005
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

ADHD Symptoms [ Time Frame: 4 days ]
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 ]
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 ]
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 ]
Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches

Eligibility Criteria

Information from the National Library of Medicine

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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
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

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): 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 of Results:

Gehricke JG, Hong N, Whalen CK, Steinhoff K, Wigal TL. Effects of transdermal nicotine on symptoms, moods, and cardiovascular activity in the everyday lives of smokers and nonsmokers with attention-deficit/hyperactivity disorder. Psychol Addict Behav. 2009 Dec;23(4):644-55. doi: 10.1037/a0017441.


Responsible Party:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00573248 History of Changes
Other Study ID Numbers:	2005-4296 TRDRP grant# 14RT-0147H
First Posted:	December 14, 2007 Key Record Dates
Results First Posted:	September 2, 2011
Last Update Posted:	September 9, 2011
Last Verified:	September 2011

Keywords provided by University of California, Irvine:


Nicotine ADHD Gender

Additional relevant MeSH terms:


Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs	Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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