A Pilot Study of Osmotic-Release Methylphenidate in Initiating and Maintaining Abstinence in Smokers With ADHD
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Cincinnati
- Enrollment
- 255
- Locations
- 6
- Primary Endpoint
- Prolonged Abstinence
Study Overview
Brief 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).
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Osmotic-Release Methylphenidate
Intervention: Osmotic-Release Methylphenidate (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale(Baseline and Study weeks 1,4,7,9,11)
- Point-prevalence Abstinence(Week 11)
Investigators
Eugene Somoza
Adjunct Professor
University of Cincinnati