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

This study has been completed.

Sponsor:

Collaborators:

National Institute on Drug Abuse (NIDA)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 13, 2005

Last Updated Date

August 17, 2012

Start Date ^ICMJE

November 2005

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Smoking abstinence

Change History

Complete list of historical versions of study NCT00253747 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

ADHD severity
Initial quit
Smoking withdrawal symptoms
Number of cigarettes per day
Use of non-cigarette tobacco products
Number of smoking days

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD

Brief Summary

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).

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

ADHD
Smoking

Intervention ^ICMJE

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.

Study Arm (s)

Active Comparator: Osmotic-Release Methylphenidate
Intervention: Drug: Osmotic-Release Methylphenidate
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

255

Completion Date

March 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00253747

Other Study ID Numbers ^ICMJE

NIDA-CTN-0029, 5U10DA013732

Has Data Monitoring Committee

Yes

Responsible Party

Eugene Somoza, University of Cincinnati

Study Sponsor ^ICMJE

University of Cincinnati

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)
Ortho-McNeil Janssen Scientific Affairs, LLC

Investigators ^ICMJE

Principal Investigator:	Eugene Somoza, M.D., Ph.D.	University of Cincinnati
Principal Investigator:	Theresa Winhusen, Ph.D.	University of Cincinnati

Information Provided By

University of Cincinnati

Verification Date

August 2012

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

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