Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
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|ClinicalTrials.gov Identifier: NCT00253747|
Recruitment Status : Completed
First Posted : November 15, 2005
Results First Posted : September 17, 2012
Last Update Posted : September 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|ADHD Smoking||Drug: Osmotic-Release Methylphenidate Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||255 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||March 2008|
|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.
- Prolonged Abstinence [ Time Frame: 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.
- Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253747
|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|
|VA New York Harbor Healthcare System|
|New York City, New York, United States, 10010|
|New York State Psychiatric Institute - Smoking Cessation Program|
|New York City, New York, United States, 10032|
|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|