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extremely slow enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Adults who meet DSM-IV-TR criteria for ADHD and smoke cigarettes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline (Chantix) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Weekly for 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled CO Levels | At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read. | 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. |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Wilens, MD | Massachusetts General Hospital | Principal Investigator |
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Recruitment was extremely slow and therefore the study was terminated early
2 studies were recruited. They participated in a previous study in our department and signed consent for the data to be used for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Data Was Analyzed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed | Posted | Weekly for 7 weeks |
|
adverse event data was not collected
only 2 subjects were recruited and they had previously participated in a study and we used the data for that study. Therefore there was no adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper | 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 |
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Extremely slow enrollment so the study was terminated early.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timothy Wilens | MassGH | 617-724-5226 | twilens@partners.org |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| 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). | Weekly for 7 weeks |
| Vital Signs | Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate. | Weekly for 7 weeks |
| Spontaneous Reports of Adverse Effects | Reports of adverse events were completed at baseline and weekly visits throughout the trial. | Weekly for 7 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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. | Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed | Posted | Weekly for 7 weeks |
|
|
| Secondary | Exhaled CO Levels | At baseline and all weekly study visits,exhaled carbon monoxide (CO) levels were read. | Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed | Posted | Weekly over 7 weeks |
|
|
| Secondary | Rates of Smoking Cessation | Varenicline has efficacy in smoking sensation; therefore smoking cessation was measured at baseline and at all study visits. | Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed | Posted | Weekly for 7 weeks |
|
|
| Secondary | 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). | Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed | Posted | Weekly for 7 weeks |
|
|
| Secondary | Vital Signs | Vital signs were collected at each study visit, including height, weight, blood pressure, and heart rate. | Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed | Posted | Weekly for 7 weeks |
|
|
| Secondary | Spontaneous Reports of Adverse Effects | Reports of adverse events were completed at baseline and weekly visits throughout the trial. | Data was not collected due to study termination, 2 subjects were recruited however their data was not analyzed | Posted | Weekly for 7 weeks |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
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| D001519 | Behavior |
| D011810 | Quinoxalines |