Phase 3 Completed N=255 Randomized Quadruple-blind Treatment

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

Attention Deficit Hyperactivity Disorder · Smoking

Source: ClinicalTrials.gov NCT00253747 ↗

Enrolled (actual)

255

Serious AEs

0.8%

Results posted

Sep 2012

Primary outcomePrimary: Prolonged Abstinence — 25; 28 participants

Summary

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Prolonged Abstinence	25; 28	—
SECONDARY Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale	38.4; 36.6; 16.4; 24.2; 20.4; 27.2	—
SECONDARY Point-prevalence Abstinence	24; 26	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00253747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.