Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this research study is to learn about the efficacy of a medication called varenicline (Chantix) in treating ADHD in adults and in reducing cigarette smoking in adults with ADHD. The investigators hypothesize that ADHD symptomatology in adults with ADHD will be improved with varenicline treatment. The investigators also hypothesize that varenicline treatment will result in significant reductions in cigarette smoking. Another objective of this study is to more fully evaluate the response and tolerability to varenicline in this group of cigarette smoking adults with ADHD.
Attention Deficit/Hyperactivity Disorder
Drug: Varenicline (Chantix)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Pilot Study of Varenicline (Chantix) in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD): Effects on ADHD and Cigarette Smoking|
- The DSM-IV based Adult ADHD Investigator Symptom Rating Scale (AISRS) [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: No ]
- Time line follow back of cigarette smoking [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]
- Exhaled CO levels [ Time Frame: Weekly over 7 weeks ] [ Designated as safety issue: Yes ]
- Rates of smoking cessation [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]
- The CGI-I and CGI-S for ADHD [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]
- Vital signs [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]
- Spontaneous reports of adverse effects [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Adults who meet DSM-IV-TR criteria for Attention Deficit Hyperactivity Disorder (ADHD)and smoke cigarettes.
Drug: Varenicline (Chantix)
Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if tolerated. Maximum dose will be 2 mg daily.
Other Name: Chantix(varenicline) is a smoking cessation medicine.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Timothy Wilens, MD||Massachusetts General Hospital|