Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)

Smoking Cessation Clinical Trial

Official title:

An Open Pilot Study of Varenicline (Chantix) in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD): Effects on ADHD and Cigarette Smoking

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00907218
• Other study ID #: 2009-P-000444
• Status: Terminated
• Phase: Phase 4
• First received: May 20, 2009
• Last updated: September 20, 2017
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male and female outpatients from 18-60 years of age;

• A cigarette smoking history of at least 3 months, and currently smoking;

• An interest in quitting smoking and a willingness to comply with all study procedures and medication instructions;

• A current DSM-IV-TR diagnosis of ADHD confirmed by clinical psychiatric evaluation and/or ADHD module of structured diagnostic interview, completed by study clinician.

• For females of child-bearing potential: pregnancy test at screening visit is negative and the subject does not plan to become pregnant during the study.

Exclusion Criteria:

• Pregnancy or breast-feeding;

• Clinically significant and/or unstable medical condition including renal, hepatic, or neurological, based upon a medical history and vital signs;

• Ongoing treatment with medications which may be affected (altered blood levels) if subjects stop smoking in the study, including insulin, theophylline, and blood thinners, as determined by clinician;

• Clinically significant cardiovascular history, including myocardial infarction, untreated hypertension, atrial fibrillation, or arrhythmia;

• Current untreated psychiatric comorbidity which the investigator judges to be of greater than mild severity, including Major Depressive Disorder;

• Current psychiatric comorbidity, including suicidality, homicidality, psychosis, determined by the clinician to be clinically significant and/or unstable

• Lifetime history of DSM-IV Bipolar I disorder, Schizophrenia, or suicide attempt as determined through clinical evaluation or diagnostic interview;

• Currently (within 3 months) meets DSM-IV criteria for abuse or dependence for any psychoactive substance other than nicotine;

• Current treatment with mood stabilizers, anti-psychotics, nicotine replacement therapies, or varenicline;

• Mental retardation (IQ < 75);

• History of intolerance or allergy to varenicline.

• Clinically significant abnormal screening values including:

• Consistent readings of hypertension (>140/90) during screening period (including screening and baseline visits), defined as two or more readings (each being the average of three measurements) at a single visit with systolic blood pressure, SBP > 140 and/or diastolic blood pressure, DBP, > 90, and confirmed by manual reading.

Subjects with isolated incidences (of triplicate average BP) of SBP > 140 and/or DBP > 90 at baseline/week 0 visit, confirmed by manual reading, which are determined to be clinically significant.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Disease
• Hyperkinesis
• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Weekly for 7 weeks
Primary	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.	Weekly for 7 weeks
Secondary	Exhaled CO Levels	At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.	Weekly over 7 weeks
Secondary	Rates of Smoking Cessation	Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits.	Weekly for 7 weeks
Secondary	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).	Weekly for 7 weeks
Secondary	Vital Signs	Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.	Weekly for 7 weeks
Secondary	Spontaneous Reports of Adverse Effects	Reports of adverse events were completed at baseline and weekly visits throughout the trial.	Weekly for 7 weeks