ADHDPhase 3NCT00253747
Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study testing Osmotic-Release Methylphenidate in people with ADHD and Smoking, run by University of Cincinnati at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- Osmotic-Release Methylphenidate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2005to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
Maryhaven, Inc.
Columbus, Ohio, 43207
VA New York Harbor Healthcare System
New York, New York, 10010
New York State Psychiatric Institute - Smoking Cessation Program
New York, New York, 10032
Kaiser Permanente (Center for Health Research)
Portland, Oregon, 97227
Mayo Clinic Nicotine Research Program
Rochester, Minnesota, 55901
About this study
Official title: A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD
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).
Read the 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.
- Being tested
- Osmotic-Release Methylphenidate, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Osmotic-Release Methylphenidate | Active comparator | Not described Receives: Drug: Osmotic-Release Methylphenidate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 7-10
Secondary outcomes (2)
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.
Measured: Baseline and Study weeks 1,4,7,9,11
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.
Measured: Week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionJan 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Ortho-McNeil Janssen Scientific Affairs, LLC
- Responsible party
- Principal investigator, Eugene Somoza, University of Cincinnati
- Investigators
- Eugene Somoza, M.D., Ph.D., Principal investigator, University of CincinnatiTheresa Winhusen, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253747
- Sponsor's protocol ID
- NIDA-CTN-0029
- Other IDs
- 5U10DA013732
- Status last verified
- Aug 2012
- First submitted
- 13 Nov 2005
- Last updated
- 17 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29370538Covey 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.
PubMed 26272693Luo 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.
PubMed 25659348Nunes 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.
PubMed 24229749Westover 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.
PubMed 23339731Heffner 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.
PubMed 22955246Winhusen 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.
PubMed 20492837Covey 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.
PubMed 20219292
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD
- ClinicalTrials.gov ID
- NCT00253747
- Acronym / sponsor ID
- NIDA-CTN-0029
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Ortho-McNeil Janssen Scientific Affairs, LLC
- Study start
- Nov 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Posted 17 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osmotic-Release Methylphenidate | Active comparator | Drug: Osmotic-Release Methylphenidate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osmotic-Release MethylphenidateOROS-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 | Osmotic-Release Methylphenidate |
| PlaceboOROS-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. | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale
Time frame: Baseline and Study weeks 1,4,7,9,11
Point-prevalence Abstinence
Time frame: Week 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29370538Luo 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.
- Derived from this study: PubMed 26272693Covey 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.
- Derived from this study: PubMed 25659348Luo 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.
- Derived from this study: PubMed 24229749Nunes 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.
- Derived from this study: PubMed 23339731Westover 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.
- Derived from this study: PubMed 22955246Heffner 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.
- Derived from this study: PubMed 20492837Winhusen 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.
- Derived from this study: PubMed 20219292Covey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Somoza, M.D., Ph.D. principal investigator
University of Cincinnati
Theresa Winhusen, Ph.D. principal investigator
University of Cincinnati
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Osmotic-Release Methylphenidate in people with ADHD and Smoking, run by University of Cincinnati at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged Abstinence (time frame: Weeks 7-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253747, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2012.