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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00253747
First Posted: November 15, 2005
Last Update Posted: September 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Eugene Somoza, University of Cincinnati
  Purpose
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).

Condition Intervention Phase
ADHD Smoking Drug: Osmotic-Release Methylphenidate Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD

Resource links provided by NLM:


Further study details as provided by Eugene Somoza, University of Cincinnati:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 255
Study Start Date: November 2005
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Maryhaven, Inc.
Columbus, Ohio, United States, 43207
United States, Oregon
Kaiser Permanente (Center for Health Research)
Portland, Oregon, United States, 97227
Sponsors and Collaborators
University of Cincinnati
National Institute on Drug Abuse (NIDA)
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Principal Investigator: Eugene Somoza, M.D., Ph.D. University of Cincinnati
Principal Investigator: Theresa Winhusen, Ph.D. University of Cincinnati
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eugene Somoza, Adjunct Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00253747     History of Changes
Other Study ID Numbers: NIDA-CTN-0029
5U10DA013732 ( U.S. NIH Grant/Contract )
First Submitted: November 13, 2005
First Posted: November 15, 2005
Results First Submitted: July 16, 2012
Results First Posted: September 17, 2012
Last Update Posted: September 17, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents