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

This study has been terminated.
(extremely slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00907218
First received: May 20, 2009
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The DSM-IV based Adult ADHD Investigator Symptom Rating Scale (AISRS) [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: No ]
  • Time line follow back of cigarette smoking [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Exhaled CO levels [ Time Frame: Weekly over 7 weeks ] [ Designated as safety issue: Yes ]
  • Rates of smoking cessation [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]
  • The CGI-I and CGI-S for ADHD [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]
  • Spontaneous reports of adverse effects [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]

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 Attention Deficit Hyperactivity Disorder (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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907218

Locations
United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Timothy Wilens, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Timothy Wilens, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00907218     History of Changes
Other Study ID Numbers: 2009-P-000444
Study First Received: May 20, 2009
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Smoking
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Habits
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013