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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253747
• Other study ID #: NIDA-CTN-0029
• Secondary ID: 5U10DA013732
• Status: Completed
• Phase: Phase 3
• First received: November 13, 2005
• Last updated: August 17, 2012
• Start date: November 2005
• Est. completion date: March 2008

Study information

• Verified date: August 2012
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity
• Smoking

Intervention

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
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Cambridge	Massachusetts
United States	Maryhaven, Inc.	Columbus	Ohio
United States	New York State Psychiatric Institute - Smoking Cessation Program	New York City	New York
United States	VA New York Harbor Healthcare System	New York City	New York
United States	Kaiser Permanente (Center for Health Research)	Portland	Oregon
United States	Mayo Clinic Nicotine Research Program	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute on Drug Abuse (NIDA), Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged Abstinence	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.	Weeks 7-10	No
Secondary	Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale	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.	Baseline and Study weeks 1,4,7,9,11	No
Secondary	Point-prevalence Abstinence	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.	Week 11	No