NCT00253747

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

September 17, 2012

Completed
Last Updated

September 17, 2012

Status Verified

August 1, 2012

Enrollment Period

2.2 years

First QC Date

November 13, 2005

Results QC Date

July 16, 2012

Last Update Submit

August 17, 2012

Conditions

ADHDSmoking

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale

    Baseline and Study weeks 1,4,7,9,11

  • Point-prevalence Abstinence

    Week 11

Study Arms (2)

Osmotic-Release Methylphenidate

ACTIVE COMPARATOR
Drug: Osmotic-Release Methylphenidate

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Osmotic-Release MethylphenidateDRUG

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.

Osmotic-Release Methylphenidate
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

Mayo Clinic Nicotine Research Program

Rochester, Minnesota, 55901, United States

Location

VA New York Harbor Healthcare System

New York, New York, 10010, United States

Location

New York State Psychiatric Institute - Smoking Cessation Program

New York, New York, 10032, United States

Location

Maryhaven, Inc.

Columbus, Ohio, 43207, United States

Location

Kaiser Permanente (Center for Health Research)

Portland, Oregon, 97227, United States

Location

Related Publications (8)

  • Luo SX, Wall M, Covey L, Hu MC, Scodes JM, Levin FR, Nunes EV, Winhusen T. Exploring longitudinal course and treatment-baseline severity interactions in secondary outcomes of smoking cessation treatment in individuals with attention-deficit hyperactivity disorder. Am J Drug Alcohol Abuse. 2018;44(6):653-659. doi: 10.1080/00952990.2017.1416474. Epub 2018 Jan 25.

    PMID: 29370538DERIVED

  • Covey LS, Hu MC, Winhusen T, Lima J, Berlin I, Nunes E. Anxiety and Depressed Mood Decline Following Smoking Abstinence in Adult Smokers with Attention Deficit Hyperactivity Disorder. J Subst Abuse Treat. 2015 Dec;59:104-8. doi: 10.1016/j.jsat.2015.07.004. Epub 2015 Jul 17.

    PMID: 26272693DERIVED

  • Luo SX, Covey LS, Hu MC, Levin FR, Nunes EV, Winhusen TM. Toward personalized smoking-cessation treatment: Using a predictive modeling approach to guide decisions regarding stimulant medication treatment of attention-deficit/hyperactivity disorder (ADHD) in smokers. Am J Addict. 2015 Jun;24(4):348-56. doi: 10.1111/ajad.12193. Epub 2015 Feb 6.

    PMID: 25659348DERIVED

  • Nunes EV, Covey LS, Brigham G, Hu MC, Levin FR, Somoza EC, Winhusen TM. Treating nicotine dependence by targeting attention-deficit/ hyperactivity disorder (ADHD) with OROS methylphenidate: the role of baseline ADHD severity and treatment response. J Clin Psychiatry. 2013 Oct;74(10):983-90. doi: 10.4088/JCP.12m08155.

    PMID: 24229749DERIVED

  • Westover AN, Nakonezny PA, Winhusen T, Adinoff B, Vongpatanasin W. Risk of methylphenidate-induced prehypertension in normotensive adult smokers with attention deficit hyperactivity disorder. J Clin Hypertens (Greenwich). 2013 Feb;15(2):124-32. doi: 10.1111/jch.12039. Epub 2012 Dec 14.

    PMID: 23339731DERIVED

  • Heffner JL, Lewis DF, Winhusen TM. Osmotic release oral system methylphenidate prevents weight gain during a smoking-cessation attempt in adults with ADHD. Nicotine Tob Res. 2013 Feb;15(2):583-7. doi: 10.1093/ntr/nts152. Epub 2012 Sep 6.

    PMID: 22955246DERIVED

  • Winhusen TM, Somoza EC, Brigham GS, Liu DS, Green CA, Covey LS, Croghan IT, Adler LA, Weiss RD, Leimberger JD, Lewis DF, Dorer EM. Impact of attention-deficit/hyperactivity disorder (ADHD) treatment on smoking cessation intervention in ADHD smokers: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2010 Dec;71(12):1680-8. doi: 10.4088/JCP.09m05089gry. Epub 2010 May 18.

    PMID: 20492837DERIVED

  • Covey LS, Hu MC, Winhusen T, Weissman J, Berlin I, Nunes EV. OROS-methylphenidate or placebo for adult smokers with attention deficit hyperactivity disorder: racial/ethnic differences. Drug Alcohol Depend. 2010 Jul 1;110(1-2):156-9. doi: 10.1016/j.drugalcdep.2010.02.002. Epub 2010 Mar 12.

    PMID: 20219292DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySmoking

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavior

Results Point of Contact

Title
Dr. Theresa Winhusen
Organization
University of CIncinnati
winhusen@carc.uc.edu
513-487-7800

Study Officials

  • Eugene Somoza, M.D., Ph.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

  • Theresa Winhusen, Ph.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

November 13, 2005

First Posted

November 15, 2005

Study Start

November 1, 2005

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

September 17, 2012

Results First Posted

September 17, 2012

Record last verified: 2012-08

Locations

US(6)