Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)

University of Cincinnati

Status and phase: Completed; Phase 3

Conditions: ADHD; Smoking

Treatments: Drug: Placebo; Drug: Osmotic-Release Methylphenidate

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00253747

NIDA-CTN-0029

5U10DA013732 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with Attention Deficit Hyperactivity Disorder (ADHD).

Full description

The primary objective of this study is to evaluate whether OROS MPH (Concerta), relative to placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with ADHD. The study will involve an estimated 252 participants, recruited from approximately 6 sites.

Enrollment: 255 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of ADHD2
• Smoked cigarettes for at least 3 months
• Currently smoking > 10 cigarettes/day
• Have an interest in quitting
• Negative urine screen for cocaine, methamphetamine, opiates, benzodiazepines, and marijuana

Exclusion criteria

• Have a clinical diagnosis for current abuse or dependence for any psychoactive substance other than nicotine, depression, or anxiety; or a life-time clinical diagnosis of psychosis or bipolar disorder
• Allergic to OROS-MPH
• Pregnant or breastfeeding
• Abnormal electrocardiogram (ECG)
• Taking a Monoamine Oxidase (MAO) Inhibitor
• Taking any medication used for treating either ADHD or smoking
• Use of tobacco products other than cigarettes in the past week
• Blood pressure readings greater than 135/85 and/or a heart rate more than 90 beats per minute on three consecutive clinic visits

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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255 participants in 2 patient groups, including a placebo group

Osmotic-Release Methylphenidate

Active Comparator group

Treatment:

Drug: Osmotic-Release Methylphenidate

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo