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Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Collaborators:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Eugene Somoza, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00253747
First received: November 13, 2005
Last updated: August 17, 2012
Last verified: August 2012

November 13, 2005
August 17, 2012
November 2005
January 2008   (final data collection date for primary outcome measure)
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.
Smoking abstinence
Complete list of historical versions of study NCT00253747 on ClinicalTrials.gov Archive Site
  • 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.
  • ADHD severity
  • Initial quit
  • Smoking withdrawal symptoms
  • Number of cigarettes per day
  • Use of non-cigarette tobacco products
  • Number of smoking days
Not Provided
Not Provided
 
Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With 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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • ADHD
  • Smoking
  • 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.
  • Drug: 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.
  • Active Comparator: Osmotic-Release Methylphenidate
    Intervention: Drug: Osmotic-Release Methylphenidate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
March 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00253747
NIDA-CTN-0029, 5U10DA013732
Yes
Eugene Somoza, University of Cincinnati
University of Cincinnati
  • National Institute on Drug Abuse (NIDA)
  • Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: Eugene Somoza, M.D., Ph.D. University of Cincinnati
Principal Investigator: Theresa Winhusen, Ph.D. University of Cincinnati
University of Cincinnati
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP