Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
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).
Drug: Osmotic-Release Methylphenidate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD|
- Prolonged Abstinence [ Time Frame: Weeks 7-10 ] [ Designated as safety issue: No ]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.
- Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale [ Time Frame: Baseline and Study weeks 1,4,7,9,11 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 11 ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2005|
|Study Completion Date:||March 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: Osmotic-Release Methylphenidate||
Drug: Osmotic-Release Methylphenidate
OROS-MPH dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
|Placebo Comparator: Placebo||
OROS-MPH (placebo) dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
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.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|United States, Minnesota|
|Mayo Clinic Nicotine Research Program|
|Rochester, Minnesota, United States, 55901|
|United States, New York|
|New York State Psychiatric Institute - Smoking Cessation Program|
|New York City, New York, United States, 10032|
|VA New York Harbor Healthcare System|
|New York City, New York, United States, 10010|
|United States, Ohio|
|Columbus, Ohio, United States, 43207|
|United States, Oregon|
|Kaiser Permanente (Center for Health Research)|
|Portland, Oregon, United States, 97227|
|Principal Investigator:||Eugene Somoza, M.D., Ph.D.||University of Cincinnati|
|Principal Investigator:||Theresa Winhusen, Ph.D.||University of Cincinnati|