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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
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.
The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)
The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54.
Time frame: Weekly for 7 weeks
Time Line Follow Back of Cigarette Smoking
The reduction in cigarette smoking, defined as the change from baseline on the amount of cigarettes per day smoked (cpd), using the time-line follow back method. This method involves asking subjects to retrospectively estimate their cigarette use 7 days to 2 years prior to the interview date.
Time frame: Weekly for 7 weeks
Exhaled CO Levels
At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.
Time frame: Weekly over 7 weeks
Rates of Smoking Cessation
Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits.
Time frame: Weekly for 7 weeks
ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S)
The Clinical Global Impression Scale of ADHD for Improvement and Severity assess overall severity and change in severity of ADHD. The CGI-I scale is rated from 1 to 7 (1=very much improved; 7=very much worse). The CGI-S is rated from 1 to 7 as well (1=not ill; 7=extremely ill).
Time frame: Weekly for 7 weeks
Vital Signs
Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.
Time frame: Weekly for 7 weeks
Spontaneous Reports of Adverse Effects
Reports of adverse events were completed at baseline and weekly visits throughout the trial.
Time frame: Weekly for 7 weeks
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