Nicotine and Behavior in Adult ADHD

• 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: University of California, Irvine
• 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

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 :

1. 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
2. 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
3. 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 :

1. Blood Pressure [ Time Frame: 4 days ]
   Average blood pressure during 2 days on nicotine patches versus 2 days on placebo patches

Eligibility Criteria

• 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

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
• Other Study ID Numbers: 2005-4296; TRDRP grant# 14RT-0147H
• First Posted: December 14, 2007
• 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