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| ID | Type | Description | Link |
|---|---|---|---|
| 5U10DA013732 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Ortho-McNeil Janssen Scientific Affairs, LLC | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osmotic-Release Methylphenidate | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osmotic-Release Methylphenidate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Somoza, M.D., Ph.D. | University of Cincinnati | Principal Investigator |
| Theresa Winhusen, Ph.D. | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Cambridge | Massachusetts | 02138 | United States | ||
| Mayo Clinic Nicotine Research Program |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29370538 | Derived | 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. | |
| 26272693 | Derived | 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. |
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This trial was conducted by the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) between December 2005 and January 2008. Six study sites recruited participants: 2 substance abuse community treatment programs, 2 Attention Deficit Hyperactivity Disorder (ADHD) clinics and 2 smoking cessation clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Osmotic-Release Methylphenidate (OROS-MPH) | For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches. |
| FG001 | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Osmotic-Release Methylphenidate (OROS-MPH) | For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Randomized participants who complete at least two visits during the first four weeks following randomization, who reach the full dose of OROS-MPH /Placebo, who have a OROS-MPH /placebo medication compliance rate of at least 75% each week for study weeks 4 through 10, and who attend at least one meeting after initiating the nicotine patch. | Posted | Number | participants | Weeks 7-10 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Osmotic-Release Methylphenidate (OROS-MPH) | For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road Traffic Accident | Injury, poisoning and procedural complications | Systematic Assessment | Hospitalized following car accident, not related, study agent temporarily discontinued |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theresa Winhusen | University of CIncinnati | 513-487-7800 | winhusen@carc.uc.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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|
| Placebo | Drug | 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. |
|
| 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. | Week 11 |
| Rochester |
| Minnesota |
| 55901 |
| United States |
| VA New York Harbor Healthcare System | New York | New York | 10010 | United States |
| New York State Psychiatric Institute - Smoking Cessation Program | New York | New York | 10032 | United States |
| Maryhaven, Inc. | Columbus | Ohio | 43207 | United States |
| Kaiser Permanente (Center for Health Research) | Portland | Oregon | 97227 | United States |
| 25659348 | Derived | 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. |
| 24229749 | Derived | 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. |
| 23339731 | Derived | 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. |
| 22955246 | Derived | 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. |
| 20492837 | Derived | 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. |
| 20219292 | Derived | 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. |
| Administrative Discharge (1), Other (2) |
|
| BG001 | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Osmotic-Release Methylphenidate (OROS-MPH) | For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches. |
| OG001 | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches. |
|
|
| 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. | Evaluable participants determined using criteria for same in the primary outcome. | Posted | Mean | Standard Deviation | DSM IV ADHD Score | Baseline and Study weeks 1,4,7,9,11 |
|
|
|
| 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. | Evaluable population determined as for primary outcome. | Posted | Number | participants | Week 11 |
|
|
|
| 2 |
| 127 |
| 35 |
| 127 |
| EG001 | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches. | 0 | 128 | 28 | 128 |
|
| Depression | Psychiatric disorders | Systematic Assessment | Hospitalized for worsening of pre-existing depression, not related, no action taken regarding study agent. |
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| Nervousness | Psychiatric disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Abnormal Dreams | Psychiatric disorders | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Initial Insomnia | Psychiatric disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Stress | Psychiatric disorders | Systematic Assessment |
|
| Agitation | Psychiatric disorders | Systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | Systematic Assessment |
|
| Psychomotor Hyperactivity | Nervous system disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Heart Rate Increased | Investigations | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Depressed Mood | Psychiatric disorders | Systematic Assessment |
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| Application Site Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dysgeusia | General disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Arthalagia | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
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