Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
- Conditions
- ADHDSmoking
- Interventions
- Drug: Placebo
- Registration Number
- NCT00253747
- Lead Sponsor
- University of Cincinnati
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Osmotic-Release Methylphenidate Osmotic-Release Methylphenidate - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Prolonged Abstinence Weeks 7-10 The smoking quit date was considered the first day of the O-MPH/P-Stnd Smoking Tx phase, which lasted for 6 weeks or more precisely 42 days (i.e., approximately weeks 5-10). The grace period was the first two weeks (i.e., days 1-14) with the remaining four weeks (days 15-42) comprising the period in which the participant must not meet criteria for treatment failure in order to be scored as obtaining prolonged abstinence. Self-report of cigarette use was assessed using a time-line follow-back (TLFB) assessment using carbon monoxide (CO)levels to correct self-reported smoking days. "Smoking days" were determined by starting with self-reported smoking and non-smoking days and using CO levels measured at weekly visits to modify the self-reports.
- Secondary Outcome Measures
Name Time Method Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale Baseline and Study weeks 1,4,7,9,11 A Generalized Estimating Equations(GEE)model which included treatment group, week, site, and treatment by week and site by week interaction effects was used to compare the groups on the DSM-IV ADHD total severity score (18 domains score at severity levels of 0\[none\]-3\[severe\]; maximum score 54) as measured at screening/baseline and study weeks 1-4 using the the interviewer-administered DSM-IV checklist and by the severity portion of the National Institute of Mental Health Clinical Global Impression (CGI) scale to rate the severity of the participant's ADHD symptoms. A single severity score ranging from 1 to 7 is yielded by the CGI severity scale.
Point-prevalence Abstinence Week 11 A logistic regression including site and treatment group will be used to model rates of achieving point prevalence abstinence as assessed at the final visit of the O-MPH/P-Stnd Smoking Tx phase. Point prevalence abstinence was defined as not smoking in the previous seven days based on self-report using the TLFB method and confirmed with a Carbon Monoxide (CO) level \<8 ppm.
Trial Locations
- Locations (6)
Mayo Clinic Nicotine Research Program
🇺🇸Rochester, Minnesota, United States
VA New York Harbor Healthcare System
🇺🇸New York City, New York, United States
Maryhaven, Inc.
🇺🇸Columbus, Ohio, United States
Kaiser Permanente (Center for Health Research)
🇺🇸Portland, Oregon, United States
New York State Psychiatric Institute - Smoking Cessation Program
🇺🇸New York City, New York, United States
Massachusetts General Hospital
🇺🇸Cambridge, Massachusetts, United States