Clinical trial NCT00253747: Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Smoking
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Ortho-McNeil Janssen Scientific Affairs, LLC
First posted: 2005-11-15
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with Attention Deficit Hyperactivity Disorder (ADHD).

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 smoking cessation counseling) in obtaining prolonged abstinence for smokers with ADHD. The study will involve an estimated 252 participants, recruited from approximately 6 sites.

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

Primary outcomes:
measure: Prolonged Abstinence
timeFrame: Weeks 7-10
Secondary outcomes:
measure: Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale
timeFrame: Baseline and Study weeks 1,4,7,9,11
measure: Point-prevalence Abstinence
timeFrame: Week 11
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Nicotine Research Program
state: Minnesota
city: New York City
country: United States
facility: VA New York Harbor Healthcare System
state: New York
city: New York City
country: United States
facility: New York State Psychiatric Institute - Smoking Cessation Program
state: New York
city: Columbus
country: United States
facility: Maryhaven, Inc.
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente (Center for Health Research)
state: Oregon
Study officials:
affiliation: University of Cincinnati
name: Eugene Somoza, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Theresa Winhusen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo SX, Wall M, Covey L, Hu MC, Scodes JM, Levin FR, Nunes EV, Winhusen T. Exploring longitudinal course and treatment-baseline severity interactions in secondary outcomes of smoking cessation treatment in individuals with attention-deficit hyperactivity disorder. Am J Drug Alcohol Abuse. 2018;44(6):653-659. doi: 10.1080/00952990.2017.1416474. Epub 2018 Jan 25.
citation: Covey LS, Hu MC, Winhusen T, Lima J, Berlin I, Nunes E. Anxiety and Depressed Mood Decline Following Smoking Abstinence in Adult Smokers with Attention Deficit Hyperactivity Disorder. J Subst Abuse Treat. 2015 Dec;59:104-8. doi: 10.1016/j.jsat.2015.07.004. Epub 2015 Jul 17.
citation: Luo SX, Covey LS, Hu MC, Levin FR, Nunes EV, Winhusen TM. Toward personalized smoking-cessation treatment: Using a predictive modeling approach to guide decisions regarding stimulant medication treatment of attention-deficit/hyperactivity disorder (ADHD) in smokers. Am J Addict. 2015 Jun;24(4):348-56. doi: 10.1111/ajad.12193. Epub 2015 Feb 6.
citation: Nunes EV, Covey LS, Brigham G, Hu MC, Levin FR, Somoza EC, Winhusen TM. Treating nicotine dependence by targeting attention-deficit/ hyperactivity disorder (ADHD) with OROS methylphenidate: the role of baseline ADHD severity and treatment response. J Clin Psychiatry. 2013 Oct;74(10):983-90. doi: 10.4088/JCP.12m08155.
citation: Westover AN, Nakonezny PA, Winhusen T, Adinoff B, Vongpatanasin W. Risk of methylphenidate-induced prehypertension in normotensive adult smokers with attention deficit hyperactivity disorder. J Clin Hypertens (Greenwich). 2013 Feb;15(2):124-32. doi: 10.1111/jch.12039. Epub 2012 Dec 14.
citation: Heffner JL, Lewis DF, Winhusen TM. Osmotic release oral system methylphenidate prevents weight gain during a smoking-cessation attempt in adults with ADHD. Nicotine Tob Res. 2013 Feb;15(2):583-7. doi: 10.1093/ntr/nts152. Epub 2012 Sep 6.
citation: Winhusen TM, Somoza EC, Brigham GS, Liu DS, Green CA, Covey LS, Croghan IT, Adler LA, Weiss RD, Leimberger JD, Lewis DF, Dorer EM. Impact of attention-deficit/hyperactivity disorder (ADHD) treatment on smoking cessation intervention in ADHD smokers: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2010 Dec;71(12):1680-8. doi: 10.4088/JCP.09m05089gry. Epub 2010 May 18.
citation: Covey LS, Hu MC, Winhusen T, Weissman J, Berlin I, Nunes EV. OROS-methylphenidate or placebo for adult smokers with attention deficit hyperactivity disorder: racial/ethnic differences. Drug Alcohol Depend. 2010 Jul 1;110(1-2):156-9. doi: 10.1016/j.drugalcdep.2010.02.002. Epub 2010 Mar 12.