Trial Outcomes & Findings for Varenicline and Smoking Cessation in Schizophrenia (NCT NCT01111149)
NCT ID: NCT01111149
Last Updated: 2014-07-17
Results Overview
Measured by blood/urine tests for nicotine and its break-down product cotinine.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Week 12
Results posted on
2014-07-17
Participant Flow
Patients were recruited from 12/15/2009 through 4/03/2012. Fliers advertising the study were placed in medical clinics. Additionally, advertisements were placed in local newspapers City Pages and The Minneapolis Star Tribune.
Enrolled participants were excluded from the trial before assignment to groups if they no longer showed interest in the study or failed drug screens.
Participant milestones
| Measure |
Sugar Pill
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
9
|
|
Overall Study
COMPLETED
|
7
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
Reasons for withdrawal
| Measure |
Sugar Pill
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
Baseline Characteristics
Varenicline and Smoking Cessation in Schizophrenia
Baseline characteristics by cohort
| Measure |
Sugar Pill
n=9 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=6 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=9 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
43 years
STANDARD_DEVIATION 8.44 • n=5 Participants
|
41.46 years
STANDARD_DEVIATION 11.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
24 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Measured by blood/urine tests for nicotine and its break-down product cotinine.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Smoking Abstinence - Serum/Urine Measurements
Serum Cotinine (Week 12)
|
198.67 ng/mL
Standard Deviation 129.84
|
207 ng/mL
Standard Deviation 130.73
|
213.8 ng/mL
Standard Deviation 137.6
|
|
Smoking Abstinence - Serum/Urine Measurements
Urine Nicotine (Week 12)
|
820 ng/mL
Standard Deviation 301.46
|
613.25 ng/mL
Standard Deviation 243.29
|
412.75 ng/mL
Standard Deviation 487.9
|
|
Smoking Abstinence - Serum/Urine Measurements
Serum Nicotine (Week 12)
|
22.57 ng/mL
Standard Deviation 24.23
|
6 ng/mL
Standard Deviation 9.59
|
15.4 ng/mL
Standard Deviation 11.61
|
|
Smoking Abstinence - Serum/Urine Measurements
Urine Cotinine (Week 12)
|
772 ng/mL
Standard Deviation 381.19
|
699.6 ng/mL
Standard Deviation 527.45
|
614.75 ng/mL
Standard Deviation 469.54
|
PRIMARY outcome
Timeframe: Week 12Number of cigarettes smoked at week 12 of the study by self-report.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Smoking Abstinence - Number of Cigarettes Smoked
|
19.71 number of cigarettes smoked
Standard Deviation 22.77
|
9.4 number of cigarettes smoked
Standard Deviation 5.47
|
17.1 number of cigarettes smoked
Standard Deviation 17.28
|
PRIMARY outcome
Timeframe: Week 12Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Smoking Abstinence - Exhaled Carbon Monoxide
|
21.14 parts per million
Standard Deviation 18.51
|
17 parts per million
Standard Deviation 13.53
|
22.6 parts per million
Standard Deviation 19.14
|
SECONDARY outcome
Timeframe: Week 12Successful outcome will be defined as a 50% or greater reduction in self-reported cigarettes per day and a 30% greater reduction in carbon monoxide and cotinine levels. Measured at week 12
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Reduction in Smoking
50% Reduction in Number of Cigarettes Smoked
|
2 participants
|
2 participants
|
1 participants
|
|
Reduction in Smoking
30% Reduction in Carbon Monoxide (Week 12)
|
2 participants
|
2 participants
|
1 participants
|
|
Reduction in Smoking
30% Reduction in Serum Cotinine (Week 12)
|
2 participants
|
4 participants
|
1 participants
|
|
Reduction in Smoking
30% Reduction in Urine Cotinine (Week 12)
|
2 participants
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 12Scale for the Assessment of Negative Symptoms (SANS) a well-established test, used to assess the presence of psychosis or negative symptoms of schizophrenia. It consists of 25 questions rated on a scale of 0 (none) to 5 (severe). With a total score range of 0 to 125 points. There are 6 subscales: Affective Flattening or Blunting - (minimum, 0; maximum 35); Inappropriate Affect (minimum, 0; maximum 5); Alogia (minimum 0; maximum 25); Avolition-Apathy (minimum 0; maximum 20); Anhedonia-Asociality (minimum 0; maximum 25); Attention (minimum 0; maximum 15). Each subscale (except for Inappropriate Affect) contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 25). The global questions are included within the Total Composite score. In each case, the larger the score, the more severe the symptoms.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Negative Symptoms of Schizophrenia - SANS
SANS Attention (Week 12)
|
0 units on a scale
Standard Deviation 0
|
0.2 units on a scale
Standard Deviation 0.45
|
0 units on a scale
Standard Deviation 0
|
|
Negative Symptoms of Schizophrenia - SANS
Inappropriate Affect (Week 12)
|
0 units on a scale
Standard Deviation 0
|
0.60 units on a scale
Standard Deviation 0.88
|
0.40 units on a scale
Standard Deviation 0.89
|
|
Negative Symptoms of Schizophrenia - SANS
SANS Anhedonia (Week 12)
|
1.57 units on a scale
Standard Deviation 1.99
|
5.8 units on a scale
Standard Deviation 7.36
|
1.4 units on a scale
Standard Deviation 3.13
|
|
Negative Symptoms of Schizophrenia - SANS
SANS Total Composite (Week 12)
|
5.86 units on a scale
Standard Deviation 5.24
|
17.2 units on a scale
Standard Deviation 9.83
|
6.20 units on a scale
Standard Deviation 5.12
|
|
Negative Symptoms of Schizophrenia - SANS
SANS Total Global (Week 12)
|
1.71 units on a scale
Standard Deviation 1.50
|
3.8 units on a scale
Standard Deviation 2.49
|
1.6 units on a scale
Standard Deviation 1.82
|
|
Negative Symptoms of Schizophrenia - SANS
SANS Affective Flattening (Week 12)
|
1.57 units on a scale
Standard Deviation 3.36
|
7 units on a scale
Standard Deviation 3.81
|
0.8 units on a scale
Standard Deviation 1.10
|
|
Negative Symptoms of Schizophrenia - SANS
SANS Alogia (Week 12)
|
0.71 units on a scale
Standard Deviation 1.89
|
0.6 units on a scale
Standard Deviation 1.34
|
0 units on a scale
Standard Deviation 0
|
|
Negative Symptoms of Schizophrenia - SANS
SANS Avolition (Week 12)
|
2 units on a scale
Standard Deviation 2.77
|
3 units on a scale
Standard Deviation 3.67
|
3.6 units on a scale
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: Week 12Impulsivity and inattention will be measured using the continuous performance test. Individuals were tasked with 359 items divided six blocks (59 in block 1, 60 in blocks 2-6). Omissions result from the failure to respond to target letters. CPT% Omissions measures the percentage of responses that qualify as omissions made during the test. Higher scores indicate increased inattention. Commissions result from responses given to non-targets. CPT% Commissions measures the percentage of responses that qualify as commissions made during the test. Higher scores indicate increased inattention. Perseverations result from reaction time less than 100 ms. CPT% Perseveration % measures the percentage of responses that qualify as perseverations made during the test. The higher the score, the greater impulsivity.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Impulsivity and Inattention
CPT % Omissions (Week 12)
|
5.62 Percentage of responses
Standard Deviation 11.14
|
0.68 Percentage of responses
Standard Deviation 1.04
|
2.42 Percentage of responses
Standard Deviation 2.66
|
|
Impulsivity and Inattention
CPT % Commissions (Week 12)
|
36.11 Percentage of responses
Standard Deviation 22.64
|
25 Percentage of responses
Standard Deviation 37.89
|
28.33 Percentage of responses
Standard Deviation 21.82
|
|
Impulsivity and Inattention
Perseveration % (Week 12)
|
0.57 Percentage of responses
Standard Deviation 0.86
|
1.05 Percentage of responses
Standard Deviation 1.84
|
0.12 Percentage of responses
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: Week 12Side effects will be monitored by a physician and/or assistant and recorded (SEP). All patients withdrawn from the study because of emerging side effects will be followed until the side effects are resolved. Each item is scored based on a scale of 0=none; 1=mild; 2=moderate; and 3=severe. Below, the data are shown for participants experiencing symptoms on week 12 of the study.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Side Effects
Dizziness
|
0 participants
|
0 participants
|
1 participants
|
|
Side Effects
Mania
|
0 participants
|
0 participants
|
0 participants
|
|
Side Effects
Chest Pain
|
0 participants
|
0 participants
|
0 participants
|
|
Side Effects
Irritability
|
1 participants
|
0 participants
|
1 participants
|
|
Side Effects
Drooling
|
0 participants
|
1 participants
|
1 participants
|
|
Side Effects
Leg Pain/Cramps
|
2 participants
|
1 participants
|
0 participants
|
|
Side Effects
Anxiety
|
3 participants
|
3 participants
|
0 participants
|
|
Side Effects
Abnormal Dreams
|
3 participants
|
1 participants
|
0 participants
|
|
Side Effects
Abdominal Pain
|
0 participants
|
1 participants
|
1 participants
|
|
Side Effects
Headache
|
3 participants
|
3 participants
|
0 participants
|
|
Side Effects
Insomnia
|
1 participants
|
0 participants
|
1 participants
|
|
Side Effects
Nausea
|
0 participants
|
2 participants
|
1 participants
|
|
Side Effects
Psychosis
|
0 participants
|
0 participants
|
1 participants
|
|
Side Effects
Dry Mouth
|
2 participants
|
0 participants
|
0 participants
|
|
Side Effects
Irregular Heart Beat
|
0 participants
|
0 participants
|
0 participants
|
|
Side Effects
Weakness/Fainting
|
2 participants
|
0 participants
|
1 participants
|
|
Side Effects
Diarrhea
|
1 participants
|
1 participants
|
0 participants
|
|
Side Effects
Vomiting
|
0 participants
|
0 participants
|
0 participants
|
|
Side Effects
Constipation
|
0 participants
|
1 participants
|
1 participants
|
|
Side Effects
Confusion
|
0 participants
|
1 participants
|
1 participants
|
|
Side Effects
Cold Sweats
|
0 participants
|
0 participants
|
0 participants
|
|
Side Effects
Blurred Vision
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 12Minnesota Nicotine Withdrawal Scale (MNWS), a patient-reported measure of nicotine withdrawal symptoms and cravings. Eight items are listed, including craving for cigarettes, irritability, frustration, or anger, anxiety, etc scored on a five point scale from 0 (normal) to 5 (severe). Patients are asked for responses for the past 24 hours and past seven days (minimum 0, maximum 32; for each subscale). The higher the score, the greater the dependence. Additionally, one question (minimum score 1, maximum score 4 measures the individual's confidence in resisting strong urges to smoke. The higher the score on this question, the greater the individual's confidence in resisting smoking urges. The Fagerstrom Test for Nicotine Dependence measures nicotine dependence and consists of six questions with a total minimum score of 0 and a maximum score of 10. The higher the score, the greater the dependence on nicotine.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Abstinence-related Symptoms - MNWS and FTND
FTND (Week 12)
|
4.86 units on a scale
Standard Deviation 1.77
|
5.2 units on a scale
Standard Deviation 1.48
|
4.4 units on a scale
Standard Deviation 3.36
|
|
Abstinence-related Symptoms - MNWS and FTND
MNWS 24 Hour Total (Week 12)
|
7.29 units on a scale
Standard Deviation 7.04
|
8.2 units on a scale
Standard Deviation 7.36
|
6.60 units on a scale
Standard Deviation 4.67
|
|
Abstinence-related Symptoms - MNWS and FTND
MNWS 7 day total (Week 12)
|
9.14 units on a scale
Standard Deviation 4.98
|
11 units on a scale
Standard Deviation 4.64
|
5.80 units on a scale
Standard Deviation 4.27
|
|
Abstinence-related Symptoms - MNWS and FTND
MNWS Resistance (Week 12)
|
2.71 units on a scale
Standard Deviation 1.11
|
3.4 units on a scale
Standard Deviation 0.55
|
2.4 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Week 12Beck Depression Inventory (BDI), a self-report rating inventory measuring characteristic attitudes and symptoms of depression consisting of 21 items with each item rated on a four point scale (0=not present to 3=severe). The accepted ranges are as follows: 0 to 9 indicates no depression, 10 to 18 indicates mild to moderate depression, 19 to 29 indicates moderate to severe depression and 30 to 63 indicates severe depression.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Depression
|
3.71 units on a scale
Standard Deviation 3.55
|
8.6 units on a scale
Standard Deviation 9.94
|
5.4 units on a scale
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: Week 12Barnes Akathisia Scale (BAS), a widely-used measurement of drug-induced akathisia. It consists of 4 questions with questions 1-3 scored on a scale of 0-3 with 0=normal and 3=severe (minimum score 0, maximum score 9; while item 4 is a global clinical assessment of akathisia rated on a scale of 0 (normal) to 5 (severe). The higher the score on each subsclae, the greater the severity of akathisia. Simpson-Angus Scale (SAS), a 10-item instrument used to evaluate patients experiencing neuroleptic-induced parkinsonism and other extrapyramidal side effects. Items are rated for severity on a 0-4 scale, with 0 being normal and 4 being severe. Minimum = 0; Maximum = 40. The higher the score, the greater the severity.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Abnormal Movements - BAS and SAS
SAS (Week 12)
|
0.2 units on a scale
Standard Deviation 0.24
|
0.76 units on a scale
Standard Deviation 0.76
|
0.42 units on a scale
Standard Deviation 0.8
|
|
Abnormal Movements - BAS and SAS
BAS Items 1-3 (Week 12)
|
0.57 units on a scale
Standard Deviation 0.98
|
0.6 units on a scale
Standard Deviation 0.89
|
0.4 units on a scale
Standard Deviation 0.89
|
|
Abnormal Movements - BAS and SAS
BAS Item 4 (Week 12)
|
0.29 units on a scale
Standard Deviation 0.49
|
0.4 units on a scale
Standard Deviation 0.55
|
0.2 units on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Week 12blood pressure will be measured.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Vital Signs
Systolic Blood Pressure (Week 12)
|
116.29 mm Hg
Standard Deviation 15.53
|
122 mm Hg
Standard Deviation 7.34
|
128.4 mm Hg
Standard Deviation 32.42
|
|
Vital Signs
Diastolic Blood Pressure (Week 12)
|
76.71 mm Hg
Standard Deviation 9.94
|
78.4 mm Hg
Standard Deviation 8.14
|
74.8 mm Hg
Standard Deviation 10.71
|
SECONDARY outcome
Timeframe: Week 12Weight will be measured for each participant. Values listed below are for week 12.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Vital Signs - Weight
|
218.39 lbs
Standard Deviation 69.64
|
213.47 lbs
Standard Deviation 35.2
|
254.78 lbs
Standard Deviation 65.50
|
SECONDARY outcome
Timeframe: Week 12Pulse will be measured. The values below were measured at week 12 of the study.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Vital Signs - Pulse
|
82.57 heart beats per minute
Standard Deviation 15.76
|
87 heart beats per minute
Standard Deviation 13.43
|
89.2 heart beats per minute
Standard Deviation 18.47
|
SECONDARY outcome
Timeframe: Week 12The Columbia-Suicide Severity Rating Scale (C-SSRS), is a survey intended to quantify the severity of suicidal ideation and behavior. The questionaire for suicidal ideation consists of 5 questions with yes (1) /no (0) answers. If answers to questions 1 and 2 are no, questions 3-5 are skipped. Minimum of 0; Maximum of 5. The questionaire for suicidal behavior consists of seven questions rated 0 for no and 1 for yes. The minimum score is 0 and the maximum score is 7. In each case, the higher the score, the greater the severity.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Suicidality
Lifetime Suicidal Ideation (week 12)
|
1.71 units on a scale
Standard Deviation 1.7
|
0.8 units on a scale
Standard Deviation 0.84
|
0.4 units on a scale
Standard Deviation 0.55
|
|
Suicidality
Lifetime Suicide Attempts (week 12)
|
1.29 units on a scale
Standard Deviation 1.7
|
1.2 units on a scale
Standard Deviation 1.3
|
0.4 units on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Week 12Scale for the Assessment of Positive Symptoms (SAPS), a well-established test, used to assess the presence of psychotic symptoms of schizophrenia. There are 34 items rated on a scale of 0-5 with 0=none and 5=severe for a minimum score of 0 and a maximum score of 170. There are 4 subscales: Hallucinations (minimum score 0; maximum score 35); Delusions (minimum score 0; maximum score 65); Bizarre Behavior (minimum score 0; maximum score 25); Positive Formal Thought Disorder (minimum score 0; maximum score 45). Each subscale contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 20). The values for the Global items are included in the Total Composite score. In each case, the higher the score, the greater the severity of symptoms.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Positive Symptoms of Schizophrenia (SAPS)
SAPS Total Composite Score - Week 12
|
3.43 units on a scale
Standard Deviation 4.86
|
7 units on a scale
Standard Deviation 7.48
|
10.6 units on a scale
Standard Deviation 7.7
|
|
Positive Symptoms of Schizophrenia (SAPS)
SAPS Total Global - Week 12
|
1.29 units on a scale
Standard Deviation 1.89
|
1.2 units on a scale
Standard Deviation 1.3
|
1.8 units on a scale
Standard Deviation 1.3
|
|
Positive Symptoms of Schizophrenia (SAPS)
SAPS Hallucinations - Week 12
|
2 units on a scale
Standard Deviation 3.83
|
2.2 units on a scale
Standard Deviation 2.59
|
3 units on a scale
Standard Deviation 4.12
|
|
Positive Symptoms of Schizophrenia (SAPS)
SAPS Delusions - Week 12
|
1.43 units on a scale
Standard Deviation 1.9
|
4.2 units on a scale
Standard Deviation 7.36
|
3.8 units on a scale
Standard Deviation 3.56
|
|
Positive Symptoms of Schizophrenia (SAPS)
SAPS Bizarre Behavior - Week 12
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0.4 units on a scale
Standard Deviation 0.55
|
|
Positive Symptoms of Schizophrenia (SAPS)
SAPS Thought Disorder - Week 12
|
0 units on a scale
Standard Deviation 0
|
0.6 units on a scale
Standard Deviation 1.34
|
3.4 units on a scale
Standard Deviation 5.64
|
SECONDARY outcome
Timeframe: Week 12Brief Psychiatric Rating Scale (BPRS), an 24-item scale measuring positive symptoms, general psychopathology, and affective symptoms commonly used for schizophrenia with each item rated on a scale of 1-7 with 1=not present and 7=severe. The minimum score is 24 and the maximum score is 168. We have used five subscales as recommended by Dingemans et al., 1995: Positive subscale (minimum score 6; maximum score 42); Negative subscale (minimum score 5; maximum score 35); Depressed subscale (minimum score 5; maximum score 35); Mania subscale (minimum score 6; maximum score 42); and Disorientation subscale (minimum score 2; maximum score 14) . For both the total score and the subscale scores, the higher the score, the greater the symptom severity. We used the BPRS version 4.0. Dingemans PMAJ, Linszen DH, Lenoir ME, Smeets RMW, 1995. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology 122:263-267.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
General Psychopathology
BPRS Total - Week 12
|
30 units on a scale
Standard Deviation 4.47
|
34.2 units on a scale
Standard Deviation 3.96
|
31.6 units on a scale
Standard Deviation 4.28
|
|
General Psychopathology
BPRS Positive Subscale - Week 12
|
8.14 units on a scale
Standard Deviation 2.73
|
9 units on a scale
Standard Deviation 2.74
|
8 units on a scale
Standard Deviation 2.92
|
|
General Psychopathology
BPRS Negative Subscale - Week 12
|
6 units on a scale
Standard Deviation 1.15
|
6.4 units on a scale
Standard Deviation 1.67
|
7.4 units on a scale
Standard Deviation 1.52
|
|
General Psychopathology
BPRS Mania Subscale - Week 12
|
6.43 units on a scale
Standard Deviation 1.13
|
6.4 units on a scale
Standard Deviation 0.55
|
8 units on a scale
Standard Deviation 2.92
|
|
General Psychopathology
BPRS Disorientation Subscale - Week 12
|
2 units on a scale
Standard Deviation 0
|
2 units on a scale
Standard Deviation 0
|
2 units on a scale
Standard Deviation 0
|
|
General Psychopathology
BPRS Depression Subscale - Week 12
|
7.43 units on a scale
Standard Deviation 2.64
|
10.4 units on a scale
Standard Deviation 2.88
|
6.2 units on a scale
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Week 12The hit reaction time is the average speed of correct responses for the entire test given in milliseconds. The higher the score, the slower the speed. The standard error is a measure of response speed consistency. The higher the overall standard error, the greater inconsistency in the response speed. The values below were measured at week 12.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Hit Reaction Time - CPT
Hit Reaction Time (week 12)
|
42.44 milliseconds
Standard Deviation 36.91
|
67.61 milliseconds
Standard Deviation 34.47
|
63.81 milliseconds
Standard Deviation 41.80
|
|
Hit Reaction Time - CPT
Hit Reaction Time Standard Error (Week 12)
|
7.20 milliseconds
Standard Deviation 4.83
|
6.96 milliseconds
Standard Deviation 2
|
8.79 milliseconds
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Week 12Variability of Standard Error (VSE) is a measure of response speed consistency. VSE measures "within respondent" variability. That is, the amount of variability the individual shows in 18 separate segments of the Continuous Performance Test in relation to his or her own overall standard error. Although VSE is a different measure than Overall Standard Error, typically the two measures produce comparable results. The higher the VSE, the greater the inconsistency in the response speed. The values shown below are the VSE for Week 12.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Variability of Standard Error - CPT
|
11.05 milliseconds
Standard Deviation 10.99
|
11.38 milliseconds
Standard Deviation 6.84
|
11.8 milliseconds
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: Week 12The value d' is a measure of the difference between the signal (non-X) and noise (X) distributions. As such, d' provides a means for assessing an individual's discriminative power since, in general, the greater the difference between the signal and noise distributions, the better the ability to distinguish and detect X and non-X stimuli. The lower the score, the better the detectability. Values shown below are for week 12.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Detectibility (d') of Continuous Performance Test
|
0.71 unitless
Standard Deviation 0.54
|
1.32 unitless
Standard Deviation 0.80
|
1.09 unitless
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: Week 12Beta represents an individual's response tendency: Some individuals are cautious and choose not to respond very often. Conceptually, such individuals want to make sure they are correct when they give a response. Higher values of Beta reflect this response style. The emphasis is on avoiding commission errors. Other individuals respond more freely to make sure they respond to most or all targets, and they tend to be less concerned about mistakenly responding to a non-target. Lower values of Beta are produced by this response style. Values shown below were obtained at week 12.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Response Style Indicator (Beta) for CPT
|
0.95 Beta
Standard Deviation 0.55
|
1.41 Beta
Standard Deviation 1.48
|
2.92 Beta
Standard Deviation 4.13
|
SECONDARY outcome
Timeframe: Week 12The Wisconsin Inventory of Smoking Dependence Motives (WISDM) consists of 68 items regarding smoking. Each item is rated on a scale of 1 (not true of me at all) to 7 (extremely true of me) leading to a minimum score of 68 and a maximum score of 476. The higher the score, the greater the dependence. Four of the items are grouped into a Craving subscale (minimum 4, maximum 28), the greater the score, the greater the craving. Five of the items are grouped into a Cognition subscale (minimum 5, maximum 35), the higher the score, the greater reliance on cigarette smoking for cognitive enhancement. WISDM scoring based on the original article by Piper et al., 2004. A multiple motives approach to tobacco dependence: the Wisconsin inventory of smoking dependence motives (WISDM-68). Journal of Consulting and Clinical Psychology 72:139-154.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Abstinence Related Symptoms - WISDM
WISDM Total (Week 12)
|
229.14 units on a scale
Standard Deviation 93.31
|
229.4 units on a scale
Standard Deviation 52.03
|
270.6 units on a scale
Standard Deviation 181.21
|
|
Abstinence Related Symptoms - WISDM
WISDM Cognition (Week 12)
|
11.57 units on a scale
Standard Deviation 8.87
|
15.4 units on a scale
Standard Deviation 5.81
|
23.2 units on a scale
Standard Deviation 16.16
|
|
Abstinence Related Symptoms - WISDM
WISDM Craving (Week 12)
|
15.14 units on a scale
Standard Deviation 5.73
|
14.2 units on a scale
Standard Deviation 3.35
|
18 units on a scale
Standard Deviation 11.11
|
SECONDARY outcome
Timeframe: Week 12The Minnesota Nicotine Withdrawal Scale (MNWS) includes two items where individuals are asked to 1) declare the percentage of time they had an urge to smoke (MNWS % Urge to Smoke); and 2) declare the percentage of time they had a strong urge to smoke (MNWS % Strong Urge). For each case, percentages range from 0% to 100% - the higher the percentage, the greater urge to smoke.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Urge to Smoke - MNWS
MNWS % Urge to Smoke (Week 12)
|
36.43 percentage of time
Standard Deviation 18.87
|
47 percentage of time
Standard Deviation 22.8
|
47 percentage of time
Standard Deviation 34.21
|
|
Urge to Smoke - MNWS
MNWS % Strong Urge (Week 12)
|
26.43 percentage of time
Standard Deviation 23.4
|
33 percentage of time
Standard Deviation 18.57
|
32.4 percentage of time
Standard Deviation 40.61
|
SECONDARY outcome
Timeframe: Week 12Abnormal Involuntary Movement Scale (AIMS), to assess abnormal involuntary movements associated with antipsychotic drugs. There are 10 questions, based on a five-point scale ranging from 0 (none) to 4 (severe). Items 11-14 are yes/no questions that have no impact on the score. The Total Score is the sum of questions 1-7 (minimum = 0; maximum = 28). The severity index consists of one question (item 8; rated 0=none to 4=severe) based on the rater's observation of abnormal movements The AIMS Global Score is the sum of three questions (each item rated 0=none to 4=severe) regarding abnormal movements overall (minimum score 0, maximum score 12). For the total score and subscores, the higher the score, the greater the severity of abnormal movements. Scoring is based on the chapter: Guy W (2000), Abnormal Involuntary Movement Scale (AIMS), in: Handbook of Psychiatric Measures (Rush AJ Jr, et al., eds). APA Publishing: Washington DC: pp. 166-167.
Outcome measures
| Measure |
Sugar Pill
n=7 Participants
Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.
Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.
|
Varenicline
n=5 Participants
Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.
Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
|
Bupropion HCl
n=5 Participants
Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.
Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
|
|---|---|---|---|
|
Abnormal Movements - AIMS
AIMS Total (Week 12)
|
0.71 units on a scale
Standard Deviation 1.25
|
1 units on a scale
Standard Deviation 1.41
|
1.40 units on a scale
Standard Deviation 2.19
|
|
Abnormal Movements - AIMS
AIMS Severity Index (Week 12)
|
0 units on a scale
Standard Deviation 0
|
0.2 units on a scale
Standard Deviation 0.45
|
0.4 units on a scale
Standard Deviation 0.89
|
|
Abnormal Movements - AIMS
AIMS Global Score (Week 12)
|
0 units on a scale
Standard Deviation 0
|
0.2 units on a scale
Standard Deviation 0.45
|
0.6 units on a scale
Standard Deviation 1.34
|
Adverse Events
Sugar Pill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Varenicline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupropion HCl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place