Status:
COMPLETED
Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Ortho-McNeil Janssen Scientific Affairs, LLC
Conditions:
ADHD
Smoking
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief 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 ...
Detailed 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 smok...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00253747
Start Date
November 1 2005
End Date
March 1 2008
Last Update
September 17 2012
Active Locations (6)
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1
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
2
Mayo Clinic Nicotine Research Program
Rochester, Minnesota, United States, 55901
3
VA New York Harbor Healthcare System
New York, New York, United States, 10010
4
New York State Psychiatric Institute - Smoking Cessation Program
New York, New York, United States, 10032