Back to resultsChantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit/Hyperactivity Disorder, Smoking Cessation
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Varenicline (Chantix)
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder focused on measuring ADHD, Attention Deficit Hyperactivity Disorder, ADHD medication, Chantix, varenicline, smoking, smoking cessation, quit smoking
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Adults who meet DSM-IV-TR criteria for ADHD and smoke cigarettes.
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
Exhaled CO Levels
At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.
Rates of Smoking Cessation
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)
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
Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.
Spontaneous Reports of Adverse Effects
Reports of adverse events were completed at baseline and weekly visits throughout the trial.
Full Information
NCT ID
NCT00907218
First Posted
May 20, 2009
Last Updated
September 20, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00907218
Brief Title
Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
extremely slow enrollment
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder, Smoking Cessation
Keywords
ADHD, Attention Deficit Hyperactivity Disorder, ADHD medication, Chantix, varenicline, smoking, smoking cessation, quit smoking
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Adults who meet DSM-IV-TR criteria for ADHD and smoke cigarettes.
Intervention Type
Drug
Intervention Name(s)
Varenicline (Chantix)
Other Intervention Name(s)
Chantix(varenicline) is a smoking cessation medicine.
Intervention Description
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.
Primary Outcome Measure Information:
Title
The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS)
Description
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
Title
Time Line Follow Back of Cigarette Smoking
Description
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
Secondary Outcome Measure Information:
Title
Exhaled CO Levels
Description
At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.
Time Frame
Weekly over 7 weeks
Title
Rates of Smoking Cessation
Description
Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits.
Time Frame
Weekly for 7 weeks
Title
ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S)
Description
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
Title
Vital Signs
Description
Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.
Time Frame
Weekly for 7 weeks
Title
Spontaneous Reports of Adverse Effects
Description
Reports of adverse events were completed at baseline and weekly visits throughout the trial.
Time Frame
Weekly for 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Wilens, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)
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