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| ID | Type | Description | Link |
|---|---|---|---|
| UL1RR025750 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline | Experimental | Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 |
|
| Placebo | Placebo Comparator | Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. | Week 24 | |
| Number of Counseling Visits Completed | Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shadi Nahvi, M.D., M.S. | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine of Yeshiva University | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. | |
| 24862167 | Derived | Nahvi S, Ning Y, Segal KS, Richter KP, Arnsten JH. Varenicline efficacy and safety among methadone maintained smokers: a randomized placebo-controlled trial. Addiction. 2014 Sep;109(9):1554-63. doi: 10.1111/add.12631. Epub 2014 Jun 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day |
| FG001 | Placebo | Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. | Posted | Number | participants | Week 12 |
|
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Adverse events were assess using both a structured questionnaire that assessed the presence of specific symptoms reported among varenicline subjects in published clinical trials, and an open-ended review of symptoms that emerged or increased in intensity following the start of study medication. Serious adverse events were defined as those which resulted in death, were life-threatening or required in-patient hospitalization.
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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 | Drug treatment in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 Varenicline: Days 1-3: 0.5 mg once a day Days 4-7: 0.5 mg twice a day Days 8-84: 1 mg twice a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemic episode preceding increase in long-acting insulin dose | Endocrine disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric outcome: incident major depressive episode | Psychiatric disorders | Systematic Assessment |
Self-reported smoking reduction could not be biochemically validated. We did not analyze changes in drug use over time. Sample size limited power to detect rare psychiatric events. Findings may not be generalizable to other populations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shadi Nahvi | Albert Einstein College of Medicine/Montefiore Medical Center | 718 920 5379 | SNAHVI@montefiore.org |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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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| Placebo | Drug | Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily |
|
|
| End of 12 week intervention period |
| Number of Study Visits Completed | Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24. | 24 weeks |
| 7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine. | Threshold of salivary cotinine ≤ 15 ng/ml was prespecified. Salivary cotinine was measured among participants who self-reported 7-day point prevalence abstinence using a semi-quantitative assay (Nymox NicAlert™). | Weeks 2, 4, 8, 12, and 24 |
| Number of Cigarettes Smoked Per Day | Weeks 2, 4, 8, 12, and 24 |
| Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | Weeks 2, 4, 8, 12, and 24 |
| Confidence in Quitting Smoking (1-10 Scale) | Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence). | Weeks 2, 4, 8, 12, and 24 |
| Importance of Quitting Smoking (1-10 Scale) | Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance). | Weeks 2, 4, 8, 12, and 24 |
| Adverse Medication Effects | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
| Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
| Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
| Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
| Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
| Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Less than/equal to high school education, | Number | participants |
|
| Married or living with partner | Number | participants |
|
| Employed | Number | participants |
|
| Life-time history of incarceration | Number | participants |
|
| Unstable housing, | Number | participants |
|
| Cigarettes/day, median (IQR) | Median | Inter-Quartile Range | cigarettes/day |
|
| Carbon monoxide, median (IQR) | Carbon monoxide, median (IQR) (n=107). The number analyzed in row differs from overall due to missing data for the carbon monoxide variable because the total n for the paper was 112. | Median | Inter-Quartile Range | p.p.m. |
|
| Carbon monoxide < 8 p.p.m., | The number analyzed in row differs from overall due to missing data for the carbon monoxide variable because the total n for the paper was 112. | Number | participants |
|
| Fagerström Test of Nicotine Dependence score, median (IQR) | 6 item scale, with scores ranging from 0 - 10 score under 3 = low nicotine dependence, 4-5 = moderate nicotine dependence, and 6-10 = high nicotine dependence | Median | Inter-Quartile Range | units on a scale |
|
| Ladder of change score, median (IQR) | Ladder of Change is to assess a smoker's position on a continuum (scale of 1 to 10) ranging from having no thoughts of quitting (1) to having quit smoking (10). | Median | Inter-Quartile Range | units on a scale |
|
| Quit importance, median (IQR) | Importance of quitting smoking measured on a scale of 1-10 (10 = high levels of quit importance). | Median | Inter-Quartile Range | units on a scale |
|
| Quit confidence, median (IQR) | Confidence of quitting smoking measured on a scale of 1-10 (10 = high levels of quit confidence). | Median | Inter-Quartile Range | units on a scale |
|
| Any past quit attempts, n | Number | participants |
|
| Median duration longest prior quit attempt, weeks (IQR) | n=82 participants who reported any past quit attempts queried | Median | Inter-Quartile Range | weeks |
|
| Any other household smoker | Number | participants |
|
| Life-time major depressive disorder | Number | participants |
|
| Life-time psychotic disorder, n | Number | participants |
|
| Life-time suicide attempt, n | Number | participants |
|
| Severe global psychiatric symptoms, n | Number | participants |
|
| Currently receiving psychiatric treatment, n | Number | participants |
|
| Hypertension, n | Number | participants |
|
| Diabetes, n | Number | participants |
|
| COPD/asthma, n | Number | participants |
|
| HIV/AIDS, n | Number | participants |
|
| Median duration methadone maintenance, years (IQR) | Median | Inter-Quartile Range | years |
|
| Median methadone dose, mg (IQR) | Median | Inter-Quartile Range | milligram |
|
| Self reported use of heroin in 30 days prior to baseline, n | Number | participants |
|
| Self reported use of other opiates in 30 days prior to baseline, n | Number | participants |
|
| Self reported use of cocaine (including crack) in 30 days prior to baseline, n | Number | participants |
|
| Self reported use of marijuana in 30 days prior to baseline, n | Number | participants |
|
| Self reported use of hazardous alcohol use in 30 days prior to baseline, n | Number | participants |
|
| Participants enrolled at clinical site 1, n | Number | participants |
|
| Participants enrolled at clinical site 2, n | Number | participants |
|
| Participants enrolled at clinical site 3, n | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. | Posted | Number | participants | Week 24 |
|
|
|
|
| Secondary | Number of Counseling Visits Completed | Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12. | Posted | Mean | Standard Deviation | visits completed | End of 12 week intervention period |
|
|
|
| Secondary | Number of Study Visits Completed | Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24. | Posted | Mean | Standard Deviation | visits completed | 24 weeks |
|
|
|
| Secondary | 7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine. | Threshold of salivary cotinine ≤ 15 ng/ml was prespecified. Salivary cotinine was measured among participants who self-reported 7-day point prevalence abstinence using a semi-quantitative assay (Nymox NicAlert™). | Because of the high rate of missing data (6 of 51 cases of self-reported abstinence not verified by cotinine), and because the semi-quantitative assay we used (Nymox NicAlert™) did not use a ≤ 15 ng/ml threshold (10 of 51 cases fell in the 10-30 ng/ml range), this data was not analyzed. | Posted | Weeks 2, 4, 8, 12, and 24 |
|
|
| Secondary | Number of Cigarettes Smoked Per Day | Posted | Median | Inter-Quartile Range | cigarettes/day | Weeks 2, 4, 8, 12, and 24 |
|
|
|
| Secondary | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | Posted | Number | participants | Weeks 2, 4, 8, 12, and 24 |
|
|
|
| Secondary | Confidence in Quitting Smoking (1-10 Scale) | Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence). | Posted | Median | Inter-Quartile Range | units on a scale | Weeks 2, 4, 8, 12, and 24 |
|
|
|
| Secondary | Importance of Quitting Smoking (1-10 Scale) | Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance). | Posted | Median | Inter-Quartile Range | units on a scale | Weeks 2, 4, 8, 12, and 24 |
|
|
|
| Secondary | Adverse Medication Effects | Posted | Number | participants | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
|
|
|
| Secondary | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Posted | Number | participants | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
|
|
|
|
| Secondary | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Posted | Number | participants | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
|
|
|
| Secondary | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Posted | Number | participants | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
|
|
|
| Secondary | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Posted | Number | participants | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
|
|
|
| Secondary | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Posted | Number | participants | over the intervention period (measured at weeks 2, 4, 8, 12, and 24) |
|
|
|
| 0 |
| 57 |
| 3 |
| 57 |
| 52 |
| 57 |
| EG001 | Placebo | Matched placebo capsules in combination with telephone quitline referral and brief individual counseling based on PHS guidelines at weeks 2, 4, 8, and 12 Placebo: Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily | 0 | 55 | 2 | 55 | 46 | 55 |
| Hospitalization for alcohol and cocaine rehabilitation | Endocrine disorders | Systematic Assessment |
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| Knee replacement following mechanical fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hospitalization for chest pain | Cardiac disorders | Systematic Assessment |
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| Hospitalization for alcohol detoxification | Endocrine disorders | Systematic Assessment |
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| Psychiatric outcome: incident manic episode | Psychiatric disorders | Systematic Assessment |
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| Psychiatric outcome: Incident psychotic disorder | Psychiatric disorders | Systematic Assessment |
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| Psychiatric outcome: suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Psychiatric outcome: severe global psychiatric symptoms | Psychiatric disorders | Systematic Assessment |
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| Medical symptom: change in taste | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| medical symptom: dry mouth | General disorders | Systematic Assessment |
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| medical symptom: change in appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| medical symptom: nausea | Gastrointestinal disorders | Systematic Assessment |
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| medical symptom: vomiting | Gastrointestinal disorders | Systematic Assessment |
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| medical symptom: gas | Gastrointestinal disorders | Systematic Assessment |
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| medical symptom: constipation | Gastrointestinal disorders | Systematic Assessment |
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| medical symptom: change in concentration | Nervous system disorders | Systematic Assessment |
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| Medical Symptom: headache | Nervous system disorders | Systematic Assessment |
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| medical symptom: fatigue | General disorders | Systematic Assessment |
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| medical symptom: insomnia | Psychiatric disorders | Systematic Assessment |
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| medical symptom: dizziness | General disorders | Systematic Assessment |
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| medical symptom: irritability | Nervous system disorders | Systematic Assessment |
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| medical symptom: vivid/more frequent dreams | Nervous system disorders | Systematic Assessment |
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| D011810 | Quinoxalines |
| At week 8 |
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| At week 12 |
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| At week 24 |
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| At week 8 |
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| At week 12 |
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| At week 24 |
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| At week 8 |
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| At week 12 |
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| At week 24 |
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| At week 8 |
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| At week 12 |
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| At week 24 |
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| Change in appetite |
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| Nausea |
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| Vomiting |
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| Gas |
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| Constipation |
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| Change in concentration |
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| Headache |
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| Fatigue |
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| Insomnia |
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| Dizziness |
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| Irritability |
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| Vivid/more frequent dreams |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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