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NCT00253747 · ClinicalTrials.gov registry record · Phase 3
Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study of Smoking and ADHD, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 255
- Enrollment target
- 6
- Study locations
NCT00253747: Completed Phase 3 study of Smoking and ADHD, sponsored by University of Cincinnati.
NCT00253747 is a Phase 3 study of Smoking and ADHD that has completed, run by University of Cincinnati. The registered enrollment target is 255 participants, below the 453-participant average among 123 other Smoking trials with a reported enrollment target (44% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00253747, a Phase 3 study of Smoking and ADHD, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 255 participants
- Enrollment target
- 6
- Study locations
Study 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).
Primary Outcome
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 (TL
Interventions
- DRUG Placebo
- DRUG Osmotic-Release Methylphenidate
Study Locations (6)
New York
- VA New York Harbor Healthcare System - New York
- New York State Psychiatric Institute - Smoking Cessation Program - New York
Massachusetts
- Massachusetts General Hospital - Cambridge
Minnesota
- Mayo Clinic Nicotine Research Program - Rochester
Ohio
- Maryhaven, Inc. - Columbus
Oregon
- Kaiser Permanente (Center for Health Research) - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00253747 record still lists
NCT00253747 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, below the 453-participant average among 123 other Smoking trials with a reported enrollment target (44% lower).
The record links to 2 conditions, with Smoking appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00253747 lists 6 locations in 5 states (New York, Massachusetts, Minnesota).
Frequently Asked Questions
What is clinical trial NCT00253747 about?
NCT00253747 is a clinical study titled "Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (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 Attentio...
What is the current status of trial NCT00253747?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 255 participants. The study started on 2005-11. Estimated completion is 2008-03.
What conditions does trial NCT00253747 study?
This clinical trial studies the following conditions: Smoking, ADHD.
What interventions are being tested in trial NCT00253747?
The interventions under investigation include: Placebo (DRUG), Osmotic-Release Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT00253747?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00253747 being conducted?
This trial has 6 study locations across Massachusetts, Minnesota, New York, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00253747's enrollment target sits among peer trials
255 49th of 123 higher than 75 of 123 other Smoking trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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