Attention Deficit/Hyperactivity DisorderPhase 4NCT00907218
Chantix in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 4 study testing Varenicline (Chantix) in people with Attention Deficit/Hyperactivity Disorder and Smoking Cessation, run by Massachusetts General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder, Smoking Cessation
- What is being tested?
- Varenicline (Chantix)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to May 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
About this study
Official title: An Open Pilot Study of Varenicline (Chantix) in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD): Effects on ADHD and Cigarette Smoking
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.
- Being tested
- Varenicline (Chantix)
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, ADHD medication, Chantix, varenicline, smoking, smoking cessation, quit smoking
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline (Chantix)Drug
Also called Chantix(varenicline) is a smoking cessation medicine.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Adults who meet DSM-IV-TR criteria for ADHD and smoke cigarettes. Receives: Drug: Varenicline (Chantix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly for 7 weeks
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.
Measured: Weekly for 7 weeks
Secondary outcomes (5)
Exhaled CO Levels
At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read.
Measured: Weekly over 7 weeks
Rates of Smoking Cessation
Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits.
Measured: Weekly for 7 weeks
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).
Measured: Weekly for 7 weeks
Vital Signs
Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate.
Measured: Weekly for 7 weeks
Spontaneous Reports of Adverse Effects
Reports of adverse events were completed at baseline and weekly visits throughout the trial.
Measured: Weekly for 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: extremely slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Wilens, MD, Massachusetts General Hospital
- Investigators
- Timothy Wilens, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907218
- Sponsor's protocol ID
- 2009-P-000444
- Status last verified
- Sep 2017
- First submitted
- 20 May 2009
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Pilot Study of Varenicline (Chantix) in Adult Smokers With Attention Deficit Hyperactivity Disorder (ADHD): Effects on ADHD and Cigarette Smoking
- ClinicalTrials.gov ID
- NCT00907218
- Acronym / sponsor ID
- 2009-P-000444
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, ADHD medication, Chantix, varenicline, smoking, smoking cessation, quit smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: extremely slow enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 May 2009 (estimated)
- Results
- Posted 23 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Varenicline (Chantix)Adults who meet DSM-IV-TR criteria for ADHD and smoke cigarettes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varenicline (Chantix)Also: Chantix(varenicline) is a smoking cessation medicine.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. | Drug | 1 |
Primary outcome
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.
5 secondary outcomes
Exhaled CO Levels
Time frame: Weekly over 7 weeks
Rates of Smoking Cessation
Time frame: Weekly for 7 weeks
ADHD Clinical Global Impressions Scale Improvement (CGI-I) and Severity (CGI-S)
Time frame: Weekly for 7 weeks
Vital Signs
Time frame: Weekly for 7 weeks
Spontaneous Reports of Adverse Effects
Time frame: Weekly for 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Wilens, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline (Chantix) in people with Attention Deficit/Hyperactivity Disorder and Smoking Cessation, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The DSM-IV Based Adult ADHD Investigator Symptom Rating Scale (AISRS) (time frame: Weekly for 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.