Cigarette Smoking, Schizophrenia
Conditions
Brief summary
The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.
Detailed description
The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups. Smoking cessation will be measured weekly through a composite measure of self-reported abstinence, end expired carbon monoxide (CO) of less than C10 ppm and urine cotinine dipstick measure of \< 30 ng/ml. The primary endpoint will be point prevalence at 12 weeks. The four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated. The point prevalence abstinence rates will also be obtained. The secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology. We hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group. Lastly, we will attempt to identify any clinical or topographic markers which predict cessation.
Interventions
DRUGvarenicline
Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
DRUGplacebo
At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Maryland, Baltimore
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 64 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-64 * Regular ten cigarette per day smoker for one year * Nicotine Dependency Score greater than or equal to four * DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder * Psychiatric medication regimen unchanged for at least 90 days * Psychiatric medication dosage unchanged for at least 30 days
Exclusion criteria
* Psychiatric hospitalization in last 6 months * Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria) * Suicide or homicide ideation with a plan in the last six months * Life time history of suicide attempt * Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years * Current treatment with Bupropion SR * DSM-IV diagnosis of alcohol or substance dependence within last 6 months\* * DSM-IV diagnosis of alcohol or substance abuse within three months \* * Pregnancy or lactation in females (+HCG) * Use of tobacco product other than cigarettes * Use of nicotine replacements * Unstable or serious medical condition in last 6 months * Regular use of cimetidine (OTC or Rx) \*Substance abuse/dependency exclusions do not apply to abuse of or dependence on nicotine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of ExpiredCO Level From Baseline | Weekly for 12 weeks | End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction. |
| Level of Nicotine Dependence by Treatment Assignment | Weekly for 12 weeks | Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Psychiatric Rating Scale (BPRS) - Total Score | Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12. | The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating. |
| Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12. | The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating. |
| Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12. | The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating. |
| Side Effects | Weekly for 12 weeks | Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug. |
Participant flow
Recruitment details
Stable outpatients who received their regular treatment at the Outpatient Research Program of the MPRC were invited to participate.
Pre-assignment details
After the enrollment of 16 participants, a total of 7 participants were withdrawn from the study prior to assignment to a treatment group (n=9). Two subjects met exclusion criteria before any study procedures were started, and 5 subjects were withdrawn during either the evaluation or pre-med phases of the study.
Participants by arm
| Arm | Count |
|---|---|
| Varenicline varenicline: Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine. | 4 |
| Placebo placebo: At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Varenicline |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 8 Participants | 4 Participants |
| Age, Continuous | 44.3 years STANDARD_DEVIATION 5.1 | 45.97 years STANDARD_DEVIATION 6.87 | 46.3 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants |
| Region of Enrollment United States | 4 participants | 8 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 4 | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 | 1 / 4 |
Outcome results
Primary
Change of ExpiredCO Level From Baseline
End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.
Time frame: Weekly for 12 weeks
Population: Some ExpiredCO data is missing due to rater error or participant absence from that study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 1 | -2.88 ppm | Standard Deviation 8.35 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 2 | -17.38 ppm | Standard Deviation 22.21 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 3 | -17.13 ppm | Standard Deviation 23.59 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 4 | -18.63 ppm | Standard Deviation 20.77 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 5 | -20.63 ppm | Standard Deviation 20.27 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 6 | -20.38 ppm | Standard Deviation 20.55 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 7 | -20.13 ppm | Standard Deviation 20.46 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 8 | -20.88 ppm | Standard Deviation 19.28 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 9 | -20.88 ppm | Standard Deviation 19.98 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 10 | -21.13 ppm | Standard Deviation 19.38 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 11 | -19.63 ppm | Standard Deviation 20.72 |
| Varenicline | Change of ExpiredCO Level From Baseline | Treatment Week 12 | -19.875 ppm | Standard Deviation 18.98 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 11 | 8.17 ppm | Standard Deviation 17.19 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 1 | 9.5 ppm | Standard Deviation 6.54 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 7 | -2.83 ppm | Standard Deviation 7.11 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 2 | -11.5 ppm | Standard Deviation 6.94 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 10 | -2.83 ppm | Standard Deviation 9.78 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 3 | -5.75 ppm | Standard Deviation 2.4 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 8 | -4.83 ppm | Standard Deviation 8.4 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 4 | 2.5 ppm | Standard Deviation 4.1 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 12 | -0.75 ppm | Standard Deviation 6.64 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 5 | -4.5 ppm | Standard Deviation 4.02 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 9 | -0.17 ppm | Standard Deviation 12.55 |
| Placebo | Change of ExpiredCO Level From Baseline | Treatment Week 6 | -3.83 ppm | Standard Deviation 7.25 |
Primary
Level of Nicotine Dependence by Treatment Assignment
Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.
Time frame: Weekly for 12 weeks
Population: Some FTND data is missing due to rater error or participant absence from that study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 2 | 4.33 units on a scale | Standard Deviation 0.58 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 7 | 4.5 units on a scale | Standard Deviation 1.73 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 4 | 3 units on a scale | Standard Deviation 3 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 8 | 4.75 units on a scale | Standard Deviation 1.89 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 1 | 4.5 units on a scale | Standard Deviation 1.3 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 9 | 5 units on a scale | Standard Deviation 2.16 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 5 | 2.75 units on a scale | Standard Deviation 2.22 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 10 | 5 units on a scale | Standard Deviation 2 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 3 | 3 units on a scale | Standard Deviation 3 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 11 | 6 units on a scale | Standard Deviation 1 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 6 | 4.25 units on a scale | Standard Deviation 1.71 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 12 | 3.5 units on a scale | Standard Deviation 3.11 |
| Varenicline | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 0 | 5.88 units on a scale | Standard Deviation 1.31 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 12 | 4.25 units on a scale | Standard Deviation 1.5 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 0 | 5.75 units on a scale | Standard Deviation 2.1 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 1 | 5.25 units on a scale | Standard Deviation 2.06 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 2 | 4.75 units on a scale | Standard Deviation 2.06 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 3 | 4.5 units on a scale | Standard Deviation 1.91 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 4 | 5 units on a scale | Standard Deviation 1.83 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 5 | 5.25 units on a scale | Standard Deviation 1.71 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 6 | 4.33 units on a scale | Standard Deviation 1.53 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 7 | 4.67 units on a scale | Standard Deviation 1.53 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 8 | 4 units on a scale | Standard Deviation 1.73 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 9 | 3.67 units on a scale | Standard Deviation 2.08 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 10 | 3.67 units on a scale | Standard Deviation 2.08 |
| Placebo | Level of Nicotine Dependence by Treatment Assignment | Treatment Week 11 | 4.33 units on a scale | Standard Deviation 1.53 |
Secondary
Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score
The anxiety/depression score is calculated by adding the scores for scales #2 Anxiety and #9 Depressive Mood. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum anxiety/depression score is 2 and the maximum psychosis score is 14. A higher score indicates a more severe anxiety/depression rating.
Time frame: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
Population: Some BPRS anxiety/depression score data is missing due to rater error or participant absence from that study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Baseline | 5.5 units on a scale | Standard Deviation 1.3 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Treatment Week 1 | 3.25 units on a scale | Standard Deviation 0.96 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Treatment Week 2 | 7.25 units on a scale | Standard Deviation 1.71 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Treatment Week 4 | 6.25 units on a scale | Standard Deviation 1.71 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Treatment Week 8 | 7.25 units on a scale | Standard Deviation 0.5 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Treatment Week 12 | 7 units on a scale | Standard Deviation 1.41 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Treatment Week 8 | 3.37 units on a scale | Standard Deviation 2.52 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Baseline | 6.75 units on a scale | Standard Deviation 2.06 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Treatment Week 4 | 8 units on a scale | Standard Deviation 4.32 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Treatment Week 1 | 8 units on a scale | Standard Deviation 3.27 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Treatment Week 12 | 7.5 units on a scale | Standard Deviation 2.65 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score | Treatment Week 2 | 7.25 units on a scale | Standard Deviation 2.99 |
Secondary
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
Time frame: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
Population: Some BPRS total score data is missing due to rater error or participant absence from that study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Baseline | 11.25 units on a scale | Standard Deviation 2.22 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Treatment Week 1 | 8.5 units on a scale | Standard Deviation 3.12 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Treatment Week 2 | 9.25 units on a scale | Standard Deviation 4.03 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Treatment Week 4 | 8.25 units on a scale | Standard Deviation 4.03 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Treatment Week 8 | 10.75 units on a scale | Standard Deviation 3.3 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Treatment Week 12 | 8.75 units on a scale | Standard Deviation 2.22 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Treatment Week 8 | 7.67 units on a scale | Standard Deviation 1.53 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Baseline | 10 units on a scale | Standard Deviation 5.94 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Treatment Week 4 | 8.5 units on a scale | Standard Deviation 4.65 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Treatment Week 1 | 11.5 units on a scale | Standard Deviation 6.03 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Treatment Week 12 | 10.5 units on a scale | Standard Deviation 3.87 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | Treatment Week 2 | 8.5 units on a scale | Standard Deviation 4.51 |
Secondary
Brief Psychiatric Rating Scale (BPRS) - Total Score
The total BPRS score is calculated by adding the scores for subscales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
Time frame: Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.
Population: Some BPRS total score data is missing due to rater error or participant absence from that study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Total Score | Baseline | 35.75 units on a scale | Standard Deviation 6.34 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Total Score | Treatment Week 1 | 33.75 units on a scale | Standard Deviation 5.56 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Total Score | Treatment Week 2 | 35.5 units on a scale | Standard Deviation 7 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Total Score | Treatment Week 4 | 31.75 units on a scale | Standard Deviation 3.4 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Total Score | Treatment Week 8 | 36.25 units on a scale | Standard Deviation 4.27 |
| Varenicline | Brief Psychiatric Rating Scale (BPRS) - Total Score | Treatment Week 12 | 34.75 units on a scale | Standard Deviation 3.3 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Total Score | Treatment Week 8 | 28 units on a scale | Standard Deviation 2.65 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Total Score | Baseline | 30.25 units on a scale | Standard Deviation 4.11 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Total Score | Treatment Week 4 | 30.25 units on a scale | Standard Deviation 6.75 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Total Score | Treatment Week 1 | 32.75 units on a scale | Standard Deviation 6.6 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Total Score | Treatment Week 12 | 32 units on a scale | Standard Deviation 3.92 |
| Placebo | Brief Psychiatric Rating Scale (BPRS) - Total Score | Treatment Week 2 | 30.25 units on a scale | Standard Deviation 4.35 |
Secondary
Side Effects
Side effects (33 items) were measured using a Side Effects Checklist (SEC). The percentage of participants endorsing each side effect were reported regardless of the severity or relation to study drug.
Time frame: Weekly for 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Varenicline | Side Effects | Bruising | 0 Participants |
| Varenicline | Side Effects | Nausea | 3 Participants |
| Varenicline | Side Effects | Enuresis | 0 Participants |
| Varenicline | Side Effects | Rash | 1 Participants |
| Varenicline | Side Effects | Diarrhea | 1 Participants |
| Varenicline | Side Effects | Restlessness | 0 Participants |
| Varenicline | Side Effects | Fever | 0 Participants |
| Varenicline | Side Effects | Hypersalivation | 3 Participants |
| Varenicline | Side Effects | Anorexia | 0 Participants |
| Varenicline | Side Effects | Sedation | 2 Participants |
| Varenicline | Side Effects | Headache | 1 Participants |
| Varenicline | Side Effects | Stiffness | 0 Participants |
| Varenicline | Side Effects | Dizziness | 1 Participants |
| Varenicline | Side Effects | Sore throat | 1 Participants |
| Varenicline | Side Effects | Insomnia | 3 Participants |
| Varenicline | Side Effects | Tremor | 0 Participants |
| Varenicline | Side Effects | Constipation | 2 Participants |
| Varenicline | Side Effects | Uticaria | 1 Participants |
| Varenicline | Side Effects | Malaise | 2 Participants |
| Varenicline | Side Effects | Vomiting | 0 Participants |
| Varenicline | Side Effects | Dry mouth | 0 Participants |
| Varenicline | Side Effects | Weight loss | 1 Participants |
| Varenicline | Side Effects | Mucosal ulceration | 0 Participants |
| Varenicline | Side Effects | Tinnitus | 0 Participants |
| Varenicline | Side Effects | Abdominal pain | 1 Participants |
| Placebo | Side Effects | Tinnitus | 0 Participants |
| Placebo | Side Effects | Abdominal pain | 4 Participants |
| Placebo | Side Effects | Anorexia | 1 Participants |
| Placebo | Side Effects | Bruising | 0 Participants |
| Placebo | Side Effects | Constipation | 0 Participants |
| Placebo | Side Effects | Diarrhea | 0 Participants |
| Placebo | Side Effects | Dizziness | 2 Participants |
| Placebo | Side Effects | Dry mouth | 2 Participants |
| Placebo | Side Effects | Enuresis | 2 Participants |
| Placebo | Side Effects | Fever | 0 Participants |
| Placebo | Side Effects | Headache | 1 Participants |
| Placebo | Side Effects | Insomnia | 1 Participants |
| Placebo | Side Effects | Malaise | 1 Participants |
| Placebo | Side Effects | Mucosal ulceration | 0 Participants |
| Placebo | Side Effects | Nausea | 1 Participants |
| Placebo | Side Effects | Rash | 1 Participants |
| Placebo | Side Effects | Restlessness | 1 Participants |
| Placebo | Side Effects | Hypersalivation | 1 Participants |
| Placebo | Side Effects | Sedation | 2 Participants |
| Placebo | Side Effects | Stiffness | 1 Participants |
| Placebo | Side Effects | Sore throat | 1 Participants |
| Placebo | Side Effects | Tremor | 1 Participants |
| Placebo | Side Effects | Uticaria | 1 Participants |
| Placebo | Side Effects | Vomiting | 1 Participants |
| Placebo | Side Effects | Weight loss | 0 Participants |