Trial · NCT00253747
Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
NCT00253747, Phase 3, Completed, University of Cincinnati; results first posted 2012-09-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD). Trials, record NCT00253747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00253747
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
- NCT number
- NCT00253747
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 255 participants, actual
- Lead sponsor
- University of Cincinnati
- Conditions
- ADHD, Smoking
- Interventions
- Osmotic-Release Methylphenidate, Placebo
- First posted
- 2005-11-15
- Last updated
- 2012-09-17
- Results first posted
- 2012-09-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prolonged Abstinence | 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. |
| Secondary | Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale | Baseline and Study weeks 1,4,7,9,11 | 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. |
| Secondary | Point-prevalence Abstinence | Week 11 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Prolonged Abstinence | Weeks 7-10 | 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. | participants | NUMBER |
| SECONDARY | Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale | Baseline and Study weeks 1,4,7,9,11 | Evaluable participants determined using criteria for same in the primary outcome. | DSM IV ADHD Score | MEAN |
| SECONDARY | Point-prevalence Abstinence | Week 11 | Evaluable population determined as for primary outcome. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Prolonged Abstinence | Osmotic-Release Methylphenidate (OROS-MPH) | 25 | participants | ||
| Prolonged Abstinence | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 28 | participants | ||
| Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale | Osmotic-Release Methylphenidate (OROS-MPH)-Baseline | 38.4 | Standard Deviation 7.6 | DSM IV ADHD Score | |
| Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Baseline | 36.6 | Standard Deviation 7.7 | DSM IV ADHD Score | |
| Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale | Osmotic-Release Methylphenidate (OROS-MPH)-Week 11 | 16.4 | Standard Deviation 12.2 | DSM IV ADHD Score | |
| Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 11 | 24.2 | Standard Deviation 23.0 | DSM IV ADHD Score | |
| Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale | Release Methylphenidate (OROS-MPH)-Week 4 | 20.4 | Standard Deviation 12.6 | DSM IV ADHD Score | |
| Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 4 | 27.2 | Standard Deviation 12.0 | DSM IV ADHD Score | |
| Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale | Release Methylphenidate (OROS-MPH)-Week 7 | 20 | Standard Deviation 12.6 | DSM IV ADHD Score | |
| Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 7 | 24 | Standard Deviation 13.3 | DSM IV ADHD Score |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Osmotic-Release Methylphenidate (OROS-MPH) | 127 | |
| Overall Study | STARTED | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 128 | |
| Overall Study | COMPLETED | Osmotic-Release Methylphenidate (OROS-MPH) | 103 | |
| Overall Study | COMPLETED | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 101 | |
| Overall Study | NOT COMPLETED | Osmotic-Release Methylphenidate (OROS-MPH) | 24 | |
| Overall Study | NOT COMPLETED | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 27 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Osmotic-Release Methylphenidate (OROS-MPH) | 35 | 127 | 35 |
| other | Headache | Nervous system disorders | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 28 | 128 | 28 |
| other | Nervousness | Psychiatric disorders | Osmotic-Release Methylphenidate (OROS-MPH) | 28 | 127 | 28 |
| other | Nervousness | Psychiatric disorders | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 21 | 128 | 21 |
| other | Anxiety | Psychiatric disorders | Osmotic-Release Methylphenidate (OROS-MPH) | 24 | 127 | 24 |
| other | Anxiety | Psychiatric disorders | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 18 | 128 | 18 |
| other | Insomnia | Psychiatric disorders | Osmotic-Release Methylphenidate (OROS-MPH) | 22 | 127 | 22 |
| other | Insomnia | Psychiatric disorders | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 17 | 128 | 17 |
| other | Nasopharyngitis | Infections and infestations | Osmotic-Release Methylphenidate (OROS-MPH) | 20 | 127 | 20 |
| other | Nasopharyngitis | Infections and infestations | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 14 | 128 | 14 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Osmotic-Release Methylphenidate (OROS-MPH) | ||
| Total, all-cause mortality | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | ||
| Total, other adverse events | Osmotic-Release Methylphenidate (OROS-MPH) | 35 | 127 |
| Total, other adverse events | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 28 | 128 |
| Total, serious adverse events | Osmotic-Release Methylphenidate (OROS-MPH) | 2 | 127 |
| Total, serious adverse events | Osmotic-Release Methylphenidate (OROS-MPH) - Placebo | 0 | 128 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10DA013732 | Clinical Trials Network, Ohio Valley Node U10DA013732 | WINHUSEN, T JOHN | UNIVERSITY OF CINCINNATI | NATIONAL INSTITUTE ON DRUG ABUSE | 2000 to 2015 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Osmotic-Release Methylphenidate (OROS-MPH) vs Osmotic-Release Methylphenidate (OROS-MPH) - Placebo: Point-prevalence Abstinence | Trial comparisons |
| Osmotic-Release Methylphenidate (OROS-MPH) vs Osmotic-Release Methylphenidate (OROS-MPH) - Placebo: Prolonged Abstinence | Trial comparisons |
| Osmotic-Release Methylphenidate (OROS-MPH) vs Osmotic-Release Methylphenidate (OROS-MPH) - Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00253747
GET https://conductscience.org/api/trials/v1/NCT00253747/events?page=2