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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA021245 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Varenicline (Chantix) is a smoking cessation treatment that was approved in 2006 by the FDA for treatment of nicotine dependence and may be particularly beneficial in smokers with schizophrenia or bipolar disorder. Early experience with varenicline indicates that it will be effective for smoking cessation in schizophrenia and in addition, has the potential to be therapeutic for cognitive dysfunction in this population. In addition, more data is needed to evaluate the safety, tolerability and effectiveness of Varenicline in people with bipolar disorder.
To assess this possibility, we will evaluate the safety and efficacy of 12 months of varenicline in schizophrenia or bipolar disorder patients who are able to quit smoking in the short term with this treatment. To do so, we will enroll 324 smokers with schizophrenia or bipolar disorder from 6 mental health clinics in Massachusetts, New Hampshire, Michigan and Minnesota into an open, 12-week smoking cessation program that includes varenicline added to weekly group cognitive behavioral therapy (CBT). Those who achieve at least 2 weeks of continuous abstinence during the last 2 weeks of the open intervention will be randomized to the relapse prevention phase: a 40-week, double blind, placebo-controlled trial of varenicline at the dose used to quit smoking added to a tapering CBT schedule. Participants will then discontinue study medications and behavioral treatment and enter a 3-month follow up phase.
Participants will be moderate to heavy smokers, aged 18-70, who have smoked an average of ≥10 cigarettes/day for the past year and who have not quit during the past year for a period >1 month.
During a 12-week open phase smoking cessation program, eligible subjects will be given active varenicline in addition to a 13-session weekly cognitive behavioral therapy program for smoking cessation. Dr. Evins (Principal Investigator) or a co-investigator will meet with subjects individually at Baseline of the Smoking Cessation Program to assess their medical eligibility for varenicline. A chart review will also be conducted by a research physician or psychiatrist.
Dr. Evins or another prescribing co-investigator will write a prescription for varenicline for each medically eligible subject. Subjects will receive their study medication at the end of each weekly group meeting. Any subject who experiences a serious side effect to the medication will meet with Dr. Evins or another medical co-investigator individually.
Subjects will set quit dates between the fourth and fifth CBT session weeks. Self-reports and exhaled carbon monoxide (CO) levels will be used to assess smoking status. Those subjects who have been abstinent for ≥2 weeks at the end of the 12th session group will be eligible for a 40-week relapse prevention program. After enrolling in the Relapse Prevention Program, subjects will be randomized to receive varenicline or placebos in addition to CBT for relapse prevention.
At Week 12 (the week before the end of the Smoking Cessation Program), Dr. Evins or another prescribing co-investigator will write prescriptions for subjects eligible for the randomized Relapse Prevention phase (i.e. successful quitters); these prescriptions will be sent to the Massachusetts General Hospital Research Pharmacy, where they will be filled according to the randomization code that the a research pharmacist will create.
When subjects come for the CBT orientation group session of the Relapse Prevention Program (Week 13), they will receive a 1-month supply of varenicline or placebo pill. During this randomized Relapse Prevention phase, medication compliance will be assessed at every group meeting by pill-count. Subjects will be asked about medication compliance and side effects at each group by the CBT group leaders and staff.
Any subject who experiences a serious side effect to the medication will meet with Dr. Evins or another medical co-investigator individually. In addition, Dr. Evins or a medical co-investigator will review the adverse events forms for each subject every week. Again, self-report and CO levels will be used to monitor smoking status.
Before and during both the open and randomized relapse prevention phases, subjects will be periodically assessed for cognitive performance, clinical characteristics, and adverse events in order to evaluate effects of withdrawal, predictors of cessation and relapse, and medication side effects. Following the completion of the 40-week relapse prevention phase, 3 follow-up assessments will be performed over a 3-month period to evaluate smoking status, cognitive functioning, and clinical effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Phase: Varenicline | Active Comparator | Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year. Because varenicline, at a dose of 1 mg twice per day, may be a more effective treatment for sustained abstinence than bupropion, it was chosen as the medication intervention for this study. |
|
| Randomized Phase: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks. In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group | 76 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Extended Duration Pharmacotherapy When Added to Antipsychotic Medications in Schizophrenia Patients Who Have Recently Quit Smoking as Assessed by the Brief Psychiatric Rating Scale | Brief Psychiatric Rating Scale is a 24 item scale that is designed to assess positive and negative symptoms, and general psychopathology in people with serious mental illness. Each item is rated on a 7-point scale from not present to extremely severe; higher scores in a range of 24 to 168, indicate more severe symptoms Ratings are based on observation and patient report. The validity of the BPRS is generally high when compared with other measures of general psychopathology. It was administered at baseline, study weeks 12, 18, 26, 38, 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A. Eden Evins, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Psychology Clinic | Birmingham | Alabama | 35233 | United States | ||
| Centerstone Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12001942 | Background | From the Centers for Disease Control and Prevention. Annual smoking attributable mortality, years of potential life lost and economic costs--United States, 1995-1999. JAMA. 2002 May 8;287(18):2355-6. No abstract available. | |
| 9040923 | Background | Addington J, el-Guebaly N, Addington D, Hodgins D. Readiness to stop smoking in schizophrenia. Can J Psychiatry. 1997 Feb;42(1):49-52. doi: 10.1177/070674379704200107. |
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44 participants were excluded after signing consent: 4 site closure, 40 Did not meet inclusion criteria, 17 Active substance abuse, 8 Unstable medical condition, 8 Unstable psychological symptoms, 4 Lost to follow-up, 3 Other
Enrolled from 03/08 to 04/12 from 10 community mental health centers in MA, MI, NH, IN, AL, and MN, participants were 18-70 years, outpatients with schizophrenia, schizoaffective or bipolar disorder, smoked 10+ cigs/day, had CO levels >9 ppm, willing to take varenicline, agreed to set a quit date within 4 wks of enrollment, and were stable
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.
Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open Phase |
|
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|
|
| Placebo | Drug | At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks. In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks. |
|
| at week 52 |
| Effect of Treatment With Varenicline Versus Placebo on Health-related Quality of Life Indices in Recently Abstinent Smokers With Schizophrenia or Bipolar Disorder as Measured by the 12-Item Short Form Health Survey (SF-12) | The 12-Item Short Form Health Survey (SF-12) is a 12-item measure of perceived health status with good reliability, validity and correlation with other health measures. It is scored via a standard algorithm, with higher scores indicating better patient self perception of health, with a mean score of 50 and a standard deviation of 10 in a representative sample of the US population. The score is computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health. This was administered at baseline and end of study. | at week 52 |
| Bloomington |
| Indiana |
| 47401 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Massachusetts Mental Health Center | Boston | Massachusetts | 02115 | United States |
| Touchstone Innovare | Grand Rapids | Michigan | 49503 | United States |
| University of Minnesota Psychological Clinic | Minneapolis | Minnesota | 55454 | United States |
| West Central Behavioral Health | Claremont | New Hampshire | 03743 | United States |
| Riverbend Community Mental Health Center | Concord | New Hampshire | 03302 | United States |
| The Mental Health Center of Greater Manchester | Manchester | New Hampshire | 03103 | United States |
| Community Council of Nashua | Nashua | New Hampshire | 03063 | United States |
| 9613620 | Background | Adler LE, Olincy A, Waldo M, Harris JG, Griffith J, Stevens K, Flach K, Nagamoto H, Bickford P, Leonard S, Freedman R. Schizophrenia, sensory gating, and nicotinic receptors. Schizophr Bull. 1998;24(2):189-202. doi: 10.1093/oxfordjournals.schbul.a033320. |
| Background | Barr, R.S.; Culhane, M.A.; Pizzagalli, D.; Goff, D.C.; and Evins, A.E. A double blind placebo controlled trial of the effects of transdermal nicotine on reward responsivity in non-smokers with schizophrenia. NIMH New Clinical Drug Evaluation Unit. Boca Raton, FL, 2006 |
| 10989262 | Background | Breese CR, Lee MJ, Adams CE, Sullivan B, Logel J, Gillen KM, Marks MJ, Collins AC, Leonard S. Abnormal regulation of high affinity nicotinic receptors in subjects with schizophrenia. Neuropsychopharmacology. 2000 Oct;23(4):351-64. doi: 10.1016/S0893-133X(00)00121-4. |
| 10661673 | Background | Carroll KM, Nich C, Sifry RL, Nuro KF, Frankforter TL, Ball SA, Fenton L, Rounsaville BJ. A general system for evaluating therapist adherence and competence in psychotherapy research in the addictions. Drug Alcohol Depend. 2000 Jan 1;57(3):225-38. doi: 10.1016/s0376-8716(99)00049-6. |
| 7864277 | Background | de Leon J, Dadvand M, Canuso C, White AO, Stanilla JK, Simpson GM. Schizophrenia and smoking: an epidemiological survey in a state hospital. Am J Psychiatry. 1995 Mar;152(3):453-5. doi: 10.1176/ajp.152.3.453. |
| 12084419 | Background | de Leon J, Diaz FJ, Rogers T, Browne D, Dinsmore L. Initiation of daily smoking and nicotine dependence in schizophrenia and mood disorders. Schizophr Res. 2002 Jul 1;56(1-2):47-54. doi: 10.1016/s0920-9964(01)00217-1. |
| 15096068 | Background | Evins AE, Cather C, Rigotti NA, Freudenreich O, Henderson DC, Olm-Shipman CM, Goff DC. Two-year follow-up of a smoking cessation trial in patients with schizophrenia: increased rates of smoking cessation and reduction. J Clin Psychiatry. 2004 Mar;65(3):307-11; quiz 452-3. doi: 10.4088/jcp.v65n0304. |
| 15876899 | Background | Evins AE, Cather C, Deckersbach T, Freudenreich O, Culhane MA, Olm-Shipman CM, Henderson DC, Schoenfeld DA, Goff DC, Rigotti NA. A double-blind placebo-controlled trial of bupropion sustained-release for smoking cessation in schizophrenia. J Clin Psychopharmacol. 2005 Jun;25(3):218-25. doi: 10.1097/01.jcp.0000162802.54076.18. |
| 16820546 | Background | Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55. doi: 10.1001/jama.296.1.47. |
| 3487983 | Background | Hughes JR, Hatsukami DK, Mitchell JE, Dahlgren LA. Prevalence of smoking among psychiatric outpatients. Am J Psychiatry. 1986 Aug;143(8):993-7. doi: 10.1176/ajp.143.8.993. |
| 16820547 | Background | Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56. |
| 16766716 | Background | Mihalak KB, Carroll FI, Luetje CW. Varenicline is a partial agonist at alpha4beta2 and a full agonist at alpha7 neuronal nicotinic receptors. Mol Pharmacol. 2006 Sep;70(3):801-5. doi: 10.1124/mol.106.025130. Epub 2006 Jun 9. |
| 19267698 | Background | Diaz FJ, James D, Botts S, Maw L, Susce MT, de Leon J. Tobacco smoking behaviors in bipolar disorder: a comparison of the general population, schizophrenia, and major depression. Bipolar Disord. 2009 Mar;11(2):154-65. doi: 10.1111/j.1399-5618.2009.00664.x. |
| 28414583 | Derived | Cather C, Hoeppner S, Pachas G, Pratt S, Achtyes E, Cieslak KM, Evins AE. Improved Depressive Symptoms in Adults with Schizophrenia During a Smoking Cessation Attempt with Varenicline and Behavioral Therapy. J Dual Diagn. 2017 Jul-Sep;13(3):168-178. doi: 10.1080/15504263.2017.1319585. Epub 2017 Apr 17. |
| 27046320 | Derived | Thorndike AN, Achtyes ED, Cather C, Pratt S, Pachas GN, Hoeppner SS, Evins AE. Weight gain and 10-year cardiovascular risk with sustained tobacco abstinence in smokers with serious mental illness: a subgroup analysis of a randomized trial. J Clin Psychiatry. 2016 Mar;77(3):e320-6. doi: 10.4088/JCP.15m10074. |
| 24399553 | Derived | Evins AE, Cather C, Pratt SA, Pachas GN, Hoeppner SS, Goff DC, Achtyes ED, Ayer D, Schoenfeld DA. Maintenance treatment with varenicline for smoking cessation in patients with schizophrenia and bipolar disorder: a randomized clinical trial. JAMA. 2014 Jan 8;311(2):145-54. doi: 10.1001/jama.2013.285113. |
| FG001 | Placebo | Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks. In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Randomized Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year. Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks. In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks. |
| BG001 | Placebo | Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks. In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | 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 | Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group | Posted | Number | participants | 76 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Safety and Tolerability of Extended Duration Pharmacotherapy When Added to Antipsychotic Medications in Schizophrenia Patients Who Have Recently Quit Smoking as Assessed by the Brief Psychiatric Rating Scale | Brief Psychiatric Rating Scale is a 24 item scale that is designed to assess positive and negative symptoms, and general psychopathology in people with serious mental illness. Each item is rated on a 7-point scale from not present to extremely severe; higher scores in a range of 24 to 168, indicate more severe symptoms Ratings are based on observation and patient report. The validity of the BPRS is generally high when compared with other measures of general psychopathology. It was administered at baseline, study weeks 12, 18, 26, 38, 52 | Only 63 subjects completed study visit #52, therefore only these subjects were analyzed at this time point for this variable | Posted | Mean | Standard Deviation | units on a scale | at week 52 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Effect of Treatment With Varenicline Versus Placebo on Health-related Quality of Life Indices in Recently Abstinent Smokers With Schizophrenia or Bipolar Disorder as Measured by the 12-Item Short Form Health Survey (SF-12) | The 12-Item Short Form Health Survey (SF-12) is a 12-item measure of perceived health status with good reliability, validity and correlation with other health measures. It is scored via a standard algorithm, with higher scores indicating better patient self perception of health, with a mean score of 50 and a standard deviation of 10 in a representative sample of the US population. The score is computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health. This was administered at baseline and end of study. | Posted | Mean | Standard Deviation | units on a scale | at week 52 |
|
At every visit: Calgary Depression Scale, the Montgomery-Asberg Depression and the Young Mania Rating Scales. AEs were ascertained by general/specific query: headache, nausea, vomiting, tachycardia, excitement, agitation, anxiety, insomnia, irritability.
Additional assessments were conducted at baseline; at study weeks 12, 18, 26, 38, 52, and 64; the Brief Psychiatric Rating Scale, Schedule for the Assessment of Negative Symptoms and assessments for health-related quality of life were conducted at baseline and weeks 12, 52, and 64.
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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 | Varenicline Open Label (Open Phase) | Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. 1. Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks. | 3 | 203 | 113 | 203 | ||
| EG001 | Varenicline | Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. 2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52 | 4 | 40 | 26 | 40 | ||
| EG002 | Placebo | 2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52 | 7 | 47 | 21 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis associated with complications of diabetes that resulted in death | Metabolism and nutrition disorders | Systematic Assessment | medical hospitalization |
| |
| Myocardial infarction | Cardiac disorders | Systematic Assessment | medical hospitalization |
| |
| Pancreatitis | Metabolism and nutrition disorders | Systematic Assessment | medical hospitalization |
| |
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment | medical hospitalization |
| |
| psychiatric hospitalization | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Excitement | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | General disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Abnormal dreams | General disorders | Systematic Assessment |
| ||
| Chest pain | Cardiac disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Lightheaded | General disorders | Non-systematic Assessment |
| ||
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A. Eden Evins, MD, MPH | Massachusetts General Hospital | 6176434679 | a_eden_evins@hms.harvard.edu |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001519 | Behavior |
| D015438 | Health Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
Not provided
Not provided
| Withdrawal by Subject |
|
| administrative |
|
| Death |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Continuous abstinence, weeks 12-76 |
|
| OG001 | Placebo | Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks. In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks. |
|
|
| OG001 | Placebo | Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks. In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks. |
|
|