Status:
TERMINATED
Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Attention Deficit/Hyperactivity Disorder
Smoking Cessation
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 inv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00907218
Start Date
April 1 2009
End Date
May 1 2010
Last Update
October 20 2017
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