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
  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
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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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
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
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

No publications provided by University of Cincinnati

Additional 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
Study First Received: November 13, 2005
Results First Received: July 16, 2012
Last Updated: August 17, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Smoking
Attention Deficit Disorder with Hyperactivity
Habits
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014