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

This study has been terminated.
(extremely slow enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00907218
First Posted: May 22, 2009
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital
  Purpose
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.

Condition Intervention Phase
Attention Deficit/Hyperactivity Disorder Smoking Cessation Drug: Varenicline (Chantix) Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Pilot Study of Varenicline (Chantix) in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD): Effects on ADHD and Cigarette Smoking

Resource links provided by NLM:


Further study details as provided by Timothy Wilens, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 2
Study Start Date: April 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Timothy Wilens, MD Massachusetts General Hospital
  More Information

Responsible Party: Timothy Wilens, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00907218     History of Changes
Other Study ID Numbers: 2009-P-000444
First Submitted: May 20, 2009
First Posted: May 22, 2009
Results First Submitted: May 9, 2013
Results First Posted: September 23, 2013
Last Update Posted: October 20, 2017
Last Verified: September 2017

Keywords provided by Timothy Wilens, MD, Massachusetts General Hospital:
ADHD
Attention Deficit Hyperactivity Disorder
ADHD medication
Chantix
varenicline
smoking
smoking cessation
quit smoking

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs