Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)
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|ClinicalTrials.gov Identifier: NCT00907218|
Recruitment Status : Terminated (extremely slow enrollment)
First Posted : May 22, 2009
Results First Posted : September 23, 2013
Last Update Posted : October 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit/Hyperactivity Disorder Smoking Cessation||Drug: Varenicline (Chantix)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Pilot Study of Varenicline (Chantix) in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD): Effects on ADHD and Cigarette Smoking|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Adults who meet DSM-IV-TR criteria for 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.
- The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS) [ Time Frame: Weekly for 7 weeks ]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 Line Follow Back of Cigarette Smoking [ Time Frame: Weekly for 7 weeks ]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.
- Exhaled CO Levels [ Time Frame: Weekly over 7 weeks ]At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.
- Rates of Smoking Cessation [ Time Frame: Weekly for 7 weeks ]Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits.
- ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S) [ Time Frame: Weekly for 7 weeks ]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).
- Vital Signs [ Time Frame: Weekly for 7 weeks ]Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.
- Spontaneous Reports of Adverse Effects [ Time Frame: Weekly for 7 weeks ]Reports of adverse events were completed at baseline and weekly visits throughout the trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907218
|Principal Investigator:||Timothy Wilens, MD||Massachusetts General Hospital|