Smoking Cessation, Substance-Related Disorders
Conditions
Keywords
methadone maintenance
Brief summary
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.
Detailed description
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.
Interventions
DRUGVarenicline
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
DRUGPlacebo
Days 1-3: 1 pill daily Days 4-7: 2 pills daily Days 8-84: 2 pills daily
Sponsors
National Center for Research Resources (NCRR)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * English speaking * Smoked at least 100 cigarettes/lifetime * Smokes 5 or more cigarettes per day * Interested in quitting smoking (preparation or contemplation state of change) * Enrolled in Einstein/Montefiore methadone program for 3 or more months * Stable methadone dose for 2 weeks * Agree to use contraception throughout the trial (among women with reproductive potential) * Willing to participate in all study components * Able to provide informed consent
Exclusion criteria
* Serious or unstable HIV/AIDS, liver, cardiovascular, or pulmonary disease * Psychiatric instability * Women who are pregnant, breastfeeding, or contemplating pregnancy * Creatinine clearance less than 30 mL/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. | Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Counseling Visits Completed | End of 12 week intervention period | Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12. |
| Number of Study Visits Completed | 24 weeks | Mean number of study visit completed out of a possible total of 6 study visits at weeks 0, 2, 4, 8, 12 and 24. |
| 7-day Point Prevalence Abstinence at 12 Weeks as Verified by Salivary Cotinine. | Weeks 2, 4, 8, 12, and 24 | 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™). |
| 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) | Weeks 2, 4, 8, 12, and 24 | Confidence of quitting smoking measure on a scale of 1-10 (10= high levels of quit confidence). |
| Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. | Week 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) | — |
| Importance of Quitting Smoking (1-10 Scale) | Weeks 2, 4, 8, 12, and 24 | Importance of quitting smoking measured on a scale of 1-10 (10=high levels of quit importance). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 57 |
| 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 | 55 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 5 |
| Overall Study | withdrew/lost to follow-up after interve | 2 | 3 |
Baseline characteristics
| Characteristic | Varenicline | Placebo | Total |
|---|---|---|---|
| Age, Customized Age, Customized | 48 years STANDARD_DEVIATION 9 | 48 years STANDARD_DEVIATION 8 | 48 years STANDARD_DEVIATION 9 |
| Any other household smoker | 34 participants | 29 participants | 63 participants |
| Any past quit attempts, n | 41 participants | 41 participants | 82 participants |
| Carbon monoxide < 8 p.p.m., | 22 participants | 18 participants | 40 participants |
| Carbon monoxide, median (IQR) | 10 p.p.m. | 9 p.p.m. | 10 p.p.m. |
| Cigarettes/day, median (IQR) | 15 cigarettes/day | 15 cigarettes/day | 15 cigarettes/day |
| COPD/asthma, n | 19 participants | 12 participants | 31 participants |
| Currently receiving psychiatric treatment, n | 24 participants | 26 participants | 50 participants |
| Diabetes, n | 13 participants | 11 participants | 24 participants |
| Employed | 15 participants | 17 participants | 32 participants |
| Fagerström Test of Nicotine Dependence score, median (IQR) | 4 units on a scale | 4 units on a scale | 4 units on a scale |
| HIV/AIDS, n | 11 participants | 10 participants | 21 participants |
| Hypertension, n | 19 participants | 22 participants | 41 participants |
| Ladder of change score, median (IQR) | 7 units on a scale | 7 units on a scale | 7 units on a scale |
| Less than/equal to high school education, | 41 participants | 46 participants | 87 participants |
| Life-time history of incarceration | 42 participants | 31 participants | 73 participants |
| Life-time major depressive disorder | 12 participants | 11 participants | 23 participants |
| Life-time psychotic disorder, n | 9 participants | 9 participants | 18 participants |
| Life-time suicide attempt, n | 9 participants | 7 participants | 16 participants |
| Married or living with partner | 23 participants | 31 participants | 54 participants |
| Median duration longest prior quit attempt, weeks (IQR) | 9 weeks | 4 weeks | 4.3 weeks |
| Median duration methadone maintenance, years (IQR) | 4 years | 7 years | 5.9 years |
| Median methadone dose, mg (IQR) | 110 milligram | 100 milligram | 110 milligram |
| Participants enrolled at clinical site 1, n | 9 participants | 7 participants | 16 participants |
| Participants enrolled at clinical site 2, n | 32 participants | 33 participants | 65 participants |
| Participants enrolled at clinical site 3, n | 16 participants | 15 participants | 31 participants |
| Quit confidence, median (IQR) | 8 units on a scale | 8 units on a scale | 8 units on a scale |
| Quit importance, median (IQR) | 10 units on a scale | 10 units on a scale | 10 units on a scale |
| Race/Ethnicity, Customized Black | 14 participants | 17 participants | 31 participants |
| Race/Ethnicity, Customized Hispanic | 32 participants | 28 participants | 60 participants |
| Race/Ethnicity, Customized Non-Hispanic white | 5 participants | 5 participants | 10 participants |
| Race/Ethnicity, Customized Other | 6 participants | 5 participants | 11 participants |
| Self reported use of cocaine (including crack) in 30 days prior to baseline, n | 17 participants | 8 participants | 25 participants |
| Self reported use of hazardous alcohol use in 30 days prior to baseline, n | 4 participants | 9 participants | 13 participants |
| Self reported use of heroin in 30 days prior to baseline, n | 8 participants | 5 participants | 13 participants |
| Self reported use of marijuana in 30 days prior to baseline, n | 14 participants | 13 participants | 27 participants |
| Self reported use of other opiates in 30 days prior to baseline, n | 11 participants | 13 participants | 24 participants |
| Severe global psychiatric symptoms, n | 9 participants | 12 participants | 21 participants |
| Sex: Female, Male Female | 31 Participants | 28 Participants | 59 Participants |
| Sex: Female, Male Male | 26 Participants | 27 Participants | 53 Participants |
| Unstable housing, | 21 participants | 14 participants | 35 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 55 |
| other Total, other adverse events | 52 / 57 | 46 / 55 |
| serious Total, serious adverse events | 3 / 57 | 2 / 55 |
Outcome results
Primary
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
Time frame: Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. | 6 participants |
| Placebo | Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. | 0 participants |
p-value: 0.03Fisher Exact
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™).
Time frame: Weeks 2, 4, 8, 12, and 24
Population: 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.
Secondary
Adverse Medication Effects
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Adverse Medication Effects | Change in taste | 18 participants |
| Varenicline | Adverse Medication Effects | Dry Mouth | 27 participants |
| Varenicline | Adverse Medication Effects | Change in appetite | 29 participants |
| Varenicline | Adverse Medication Effects | Nausea | 29 participants |
| Varenicline | Adverse Medication Effects | Vomiting | 11 participants |
| Varenicline | Adverse Medication Effects | Gas | 19 participants |
| Varenicline | Adverse Medication Effects | Constipation | 23 participants |
| Varenicline | Adverse Medication Effects | Change in concentration | 6 participants |
| Varenicline | Adverse Medication Effects | Headache | 11 participants |
| Varenicline | Adverse Medication Effects | Fatigue | 15 participants |
| Varenicline | Adverse Medication Effects | Insomnia | 15 participants |
| Varenicline | Adverse Medication Effects | Dizziness | 9 participants |
| Varenicline | Adverse Medication Effects | Irritability | 10 participants |
| Varenicline | Adverse Medication Effects | Vivid/more frequent dreams | 18 participants |
| Placebo | Adverse Medication Effects | Insomnia | 13 participants |
| Placebo | Adverse Medication Effects | Change in taste | 14 participants |
| Placebo | Adverse Medication Effects | Change in concentration | 6 participants |
| Placebo | Adverse Medication Effects | Dry Mouth | 23 participants |
| Placebo | Adverse Medication Effects | Irritability | 8 participants |
| Placebo | Adverse Medication Effects | Change in appetite | 18 participants |
| Placebo | Adverse Medication Effects | Headache | 18 participants |
| Placebo | Adverse Medication Effects | Nausea | 14 participants |
| Placebo | Adverse Medication Effects | Dizziness | 8 participants |
| Placebo | Adverse Medication Effects | Vomiting | 8 participants |
| Placebo | Adverse Medication Effects | Fatigue | 13 participants |
| Placebo | Adverse Medication Effects | Gas | 15 participants |
| Placebo | Adverse Medication Effects | Vivid/more frequent dreams | 22 participants |
| Placebo | Adverse Medication Effects | Constipation | 9 participants |
Secondary
Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m.
Time frame: Week 24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. | 3 participants |
| Placebo | Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. | 0 participants |
p-value: 0.24Fisher Exact
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).
Time frame: Weeks 2, 4, 8, 12, and 24
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Varenicline | Confidence in Quitting Smoking (1-10 Scale) | At week 4 | 9 units on a scale |
| Varenicline | Confidence in Quitting Smoking (1-10 Scale) | At week 12 | 9 units on a scale |
| Varenicline | Confidence in Quitting Smoking (1-10 Scale) | At week 8 | 9 units on a scale |
| Varenicline | Confidence in Quitting Smoking (1-10 Scale) | At week 24 | 8 units on a scale |
| Varenicline | Confidence in Quitting Smoking (1-10 Scale) | At week 2 | 8 units on a scale |
| Placebo | Confidence in Quitting Smoking (1-10 Scale) | At week 24 | 8 units on a scale |
| Placebo | Confidence in Quitting Smoking (1-10 Scale) | At week 2 | 8 units on a scale |
| Placebo | Confidence in Quitting Smoking (1-10 Scale) | At week 4 | 8 units on a scale |
| Placebo | Confidence in Quitting Smoking (1-10 Scale) | At week 8 | 9 units on a scale |
| Placebo | Confidence in Quitting Smoking (1-10 Scale) | At week 12 | 8 units on a scale |
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).
Time frame: Weeks 2, 4, 8, 12, and 24
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Varenicline | Importance of Quitting Smoking (1-10 Scale) | At week 2 | 10 units on a scale |
| Varenicline | Importance of Quitting Smoking (1-10 Scale) | At week 4 | 10 units on a scale |
| Varenicline | Importance of Quitting Smoking (1-10 Scale) | At week 8 | 10 units on a scale |
| Varenicline | Importance of Quitting Smoking (1-10 Scale) | At week 12 | 10 units on a scale |
| Varenicline | Importance of Quitting Smoking (1-10 Scale) | At week 24 | 10 units on a scale |
| Placebo | Importance of Quitting Smoking (1-10 Scale) | At week 24 | 10 units on a scale |
| Placebo | Importance of Quitting Smoking (1-10 Scale) | At week 12 | 10 units on a scale |
| Placebo | Importance of Quitting Smoking (1-10 Scale) | At week 4 | 10 units on a scale |
| Placebo | Importance of Quitting Smoking (1-10 Scale) | At week 2 | 10 units on a scale |
| Placebo | Importance of Quitting Smoking (1-10 Scale) | At week 8 | 10 units on a scale |
Secondary
Number of Cigarettes Smoked Per Day
Time frame: Weeks 2, 4, 8, 12, and 24
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Varenicline | Number of Cigarettes Smoked Per Day | At week 4 | 2 cigarettes/day |
| Varenicline | Number of Cigarettes Smoked Per Day | At week 12 | 2 cigarettes/day |
| Varenicline | Number of Cigarettes Smoked Per Day | At week 8 | 3 cigarettes/day |
| Varenicline | Number of Cigarettes Smoked Per Day | At week 24 | 4 cigarettes/day |
| Varenicline | Number of Cigarettes Smoked Per Day | At week 2 | 3 cigarettes/day |
| Placebo | Number of Cigarettes Smoked Per Day | At week 24 | 5 cigarettes/day |
| Placebo | Number of Cigarettes Smoked Per Day | At week 2 | 6 cigarettes/day |
| Placebo | Number of Cigarettes Smoked Per Day | At week 4 | 5 cigarettes/day |
| Placebo | Number of Cigarettes Smoked Per Day | At week 8 | 5 cigarettes/day |
| Placebo | Number of Cigarettes Smoked Per Day | At week 12 | 5 cigarettes/day |
Secondary
Number of Counseling Visits Completed
Participants were offered 5 counseling visits at weeks 0, 2, 4, 8, 12.
Time frame: End of 12 week intervention period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Number of Counseling Visits Completed | 1.96 visits completed | Standard Deviation 1.64 |
| Placebo | Number of Counseling Visits Completed | 1.85 visits completed | Standard Deviation 1.65 |
Secondary
Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours
Time frame: Weeks 2, 4, 8, 12, and 24
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | At week 4 | 35 participants |
| Varenicline | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | At week 12 | 37 participants |
| Varenicline | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | At week 8 | 37 participants |
| Varenicline | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | At week 24 | 41 participants |
| Varenicline | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | At week 2 | 33 participants |
| Placebo | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | At week 24 | 30 participants |
| Placebo | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | At week 2 | 25 participants |
| Placebo | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | At week 4 | 27 participants |
| Placebo | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | At week 8 | 32 participants |
| Placebo | Number of Participants With an Attempt to Quit Smoking That Lasted ≥ 24 Hours | At week 12 | 25 participants |
Secondary
Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 4 | 0 participants |
| Varenicline | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 12 | 0 participants |
| Varenicline | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 8 | 2 participants |
| Varenicline | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 24 | 2 participants |
| Varenicline | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 2 | 0 participants |
| Placebo | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 24 | 2 participants |
| Placebo | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 2 | 0 participants |
| Placebo | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 4 | 0 participants |
| Placebo | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 8 | 0 participants |
| Placebo | Number of Participants With Major Depressive Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 12 | 1 participants |
Secondary
Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 12 | 0 participants |
| Varenicline | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 2 | 0 participants |
| Varenicline | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 8 | 0 participants |
| Varenicline | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 24 | 0 participants |
| Varenicline | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 4 | 0 participants |
| Placebo | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 24 | 0 participants |
| Placebo | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 4 | 0 participants |
| Placebo | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 8 | 0 participants |
| Placebo | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 12 | 0 participants |
| Placebo | Number of Participants With Manic Episode, Assessed by the Mini-International Neuropsychiatric Interview | Week 2 | 0 participants |
Secondary
Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Week 8 | 1 participants |
| Varenicline | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Week 24 | 2 participants |
| Varenicline | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Week 4 | 0 participants |
| Varenicline | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Week 2 | 0 participants |
| Varenicline | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Week 12 | 1 participants |
| Placebo | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Week 12 | 1 participants |
| Placebo | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Week 4 | 0 participants |
| Placebo | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Week 8 | 0 participants |
| Placebo | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Week 2 | 2 participants |
| Placebo | Number of Participants With Psychotic Disorder, Assessed by the Mini-International Neuropsychiatric Interview | Week 24 | 1 participants |
Secondary
Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Week 4 | 4 participants |
| Varenicline | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Week 12 | 8 participants |
| Varenicline | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Week 8 | 6 participants |
| Varenicline | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Week 24 | 5 participants |
| Varenicline | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Week 2 | 9 participants |
| Placebo | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Week 24 | 5 participants |
| Placebo | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Week 2 | 11 participants |
| Placebo | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Week 4 | 7 participants |
| Placebo | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Week 8 | 7 participants |
| Placebo | Number of Participants With Severe Global Psychiatric Symptoms Assessed by the Brief Symptom Inventory | Week 12 | 5 participants |
p-value: 0.15Wilcoxon (Mann-Whitney)
Secondary
Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale
Time frame: over the intervention period (measured at weeks 2, 4, 8, 12, and 24)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Week 12 | 1 participants |
| Varenicline | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Week 24 | 1 participants |
| Varenicline | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Week 2 | 1 participants |
| Varenicline | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Week 4 | 1 participants |
| Varenicline | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Week 8 | 1 participants |
| Placebo | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Week 8 | 1 participants |
| Placebo | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Week 4 | 0 participants |
| Placebo | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Week 24 | 1 participants |
| Placebo | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Week 12 | 2 participants |
| Placebo | Number of Patients With Suicial Ideation (Wishes to be Dead, or Thoughts of Killing Self) Assessed Using the Columbia Suicide Severity Scale | Week 2 | 1 participants |
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Varenicline | Number of Study Visits Completed | 5.72 visits completed | Standard Deviation 0.7 |
| Placebo | Number of Study Visits Completed | 5.36 visits completed | Standard Deviation 1.38 |