At a glance
ClinicalIndex Comparison Record- ✓Clinical diagnosis of ADHD
- ✓Smoked cigarettes for at least 3 months
- ✓Currently smoking more than 10 cigarettes per day
- ✓Have an interest in quitting smoking
- ✕Current or past abuse or dependence on psychoactive substances other than nicotine
- ✕History of depression or anxiety as primary psychiatric condition
- ✕Lifetime history of psychosis or bipolar disorder
- ✕Allergic to osmotic-release methylphenidate
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD
In Brief
A Phase 3 clinical trial evaluating Osmotic-Release Methylphenidate and Placebo for ADHD and Smoking. Completed, enrolled 255 participants across 6 sites.
Detailed 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).
Study Details
Timeline
Interventions
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.
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.