Trial Outcomes & Findings for Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder (NCT NCT01010204)
NCT ID: NCT01010204
Last Updated: 2017-12-04
Results Overview
To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
12 weeks
Results posted on
2017-12-04
Participant Flow
Participant milestones
| Measure |
Varenicline
We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
Placebo
We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
24
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
Varenicline
We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
Placebo
We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
psychiatric hospitalization
|
2
|
1
|
Baseline Characteristics
Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Varenicline
n=31 Participants
We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
Placebo
n=29 Participants
We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
45.95 years
STANDARD_DEVIATION 9.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: bipolar subjects
To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks
Outcome measures
| Measure |
Varenicline
n=31 Participants
We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
Placebo
n=29 Participants
We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
|---|---|---|
|
7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks
|
15 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: bipolar patients
To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence
Outcome measures
| Measure |
Varenicline
n=31 Participants
We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
Placebo
n=29 Participants
We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
|---|---|---|
|
7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Bipolar Patients
Evaluate the safety of varenicline in treatment-emergent hypomania, mania, mixed or depressed episodes or being associated suicidal or aggressive behavior or psychotic symptoms when used as adjunctive treatment in participants with bipolar disorder.
Outcome measures
| Measure |
Varenicline
n=31 Participants
We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
Placebo
n=29 Participants
We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
|---|---|---|
|
Participants Experiencing Neuropsychiatric Events
|
7 Participants
|
2 Participants
|
Adverse Events
Varenicline
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=31 participants at risk
We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
Placebo
n=29 participants at risk
We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Psychiatric disorders
exacerbation of anxiety
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Psychiatric disorders
agitation, hostility, alcohol drug abuse
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
asthma with acute exacerbation
|
3.2%
1/31 • Number of events 1 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Psychiatric disorders
alcohol intoxication
|
0.00%
0/31 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
upper left arm weakness
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
0.00%
0/31 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
3.2%
1/31 • Number of events 1 • 6 months
|
0.00%
0/29 • 6 months
|
|
Cardiac disorders
chest pain, left hand numbness
|
0.00%
0/31 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Varenicline
n=31 participants at risk
We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
Placebo
n=29 participants at risk
We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
6.5%
2/31 • Number of events 2 • 6 months
|
10.3%
3/29 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
constipation
|
22.6%
7/31 • Number of events 7 • 6 months
|
17.2%
5/29 • Number of events 5 • 6 months
|
|
General disorders
dry mouth
|
29.0%
9/31 • Number of events 9 • 6 months
|
31.0%
9/29 • Number of events 9 • 6 months
|
|
Gastrointestinal disorders
flatulance
|
35.5%
11/31 • Number of events 11 • 6 months
|
37.9%
11/29 • Number of events 11 • 6 months
|
|
Gastrointestinal disorders
vomiting
|
9.7%
3/31 • Number of events 3 • 6 months
|
20.7%
6/29 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
nausea
|
41.9%
13/31 • Number of events 13 • 6 months
|
31.0%
9/29 • Number of events 9 • 6 months
|
|
Gastrointestinal disorders
heart burn
|
22.6%
7/31 • Number of events 7 • 6 months
|
20.7%
6/29 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
abdominal pain
|
19.4%
6/31 • Number of events 6 • 6 months
|
20.7%
6/29 • Number of events 6 • 6 months
|
|
Gastrointestinal disorders
gastroesophageal reflux
|
22.6%
7/31 • Number of events 7 • 6 months
|
6.9%
2/29 • Number of events 2 • 6 months
|
|
Psychiatric disorders
depressed mood
|
25.8%
8/31 • Number of events 8 • 6 months
|
6.9%
2/29 • Number of events 2 • 6 months
|
|
Psychiatric disorders
anxiety
|
6.5%
2/31 • Number of events 2 • 6 months
|
0.00%
0/29 • 6 months
|
|
Psychiatric disorders
mood swings
|
6.5%
2/31 • Number of events 2 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Psychiatric disorders
insomnia
|
45.2%
14/31 • Number of events 14 • 6 months
|
27.6%
8/29 • Number of events 8 • 6 months
|
|
Psychiatric disorders
abnormal dreams
|
58.1%
18/31 • Number of events 18 • 6 months
|
31.0%
9/29 • Number of events 9 • 6 months
|
|
Psychiatric disorders
suicidal ideation
|
6.5%
2/31 • Number of events 2 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Nervous system disorders
somnolence
|
6.5%
2/31 • Number of events 2 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Nervous system disorders
headache
|
35.5%
11/31 • Number of events 11 • 6 months
|
41.4%
12/29 • Number of events 12 • 6 months
|
|
Nervous system disorders
dizziness
|
6.5%
2/31 • Number of events 2 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Nervous system disorders
bad taste
|
12.9%
4/31 • Number of events 4 • 6 months
|
6.9%
2/29 • Number of events 2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
arthralgia/pain
|
6.5%
2/31 • Number of events 2 • 6 months
|
6.9%
2/29 • Number of events 2 • 6 months
|
|
General disorders
fatigue/lethargy
|
25.8%
8/31 • Number of events 8 • 6 months
|
17.2%
5/29 • Number of events 5 • 6 months
|
|
General disorders
asthenia-weakness
|
3.2%
1/31 • Number of events 1 • 6 months
|
13.8%
4/29 • Number of events 4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
runny nose
|
19.4%
6/31 • Number of events 6 • 6 months
|
20.7%
6/29 • Number of events 6 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
12.9%
4/31 • Number of events 4 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
rash
|
9.7%
3/31 • Number of events 3 • 6 months
|
6.9%
2/29 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
increased appetite
|
22.6%
7/31 • Number of events 7 • 6 months
|
20.7%
6/29 • Number of events 6 • 6 months
|
|
Metabolism and nutrition disorders
decreased appetite
|
25.8%
8/31 • Number of events 8 • 6 months
|
20.7%
6/29 • Number of events 6 • 6 months
|
|
Metabolism and nutrition disorders
weight gain
|
6.5%
2/31 • Number of events 2 • 6 months
|
6.9%
2/29 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
weight loss
|
6.5%
2/31 • Number of events 2 • 6 months
|
3.4%
1/29 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
urinary tract infection
|
6.5%
2/31 • Number of events 2 • 6 months
|
0.00%
0/29 • 6 months
|
Additional Information
K.N. Roy Chengappa, Md
Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center
Phone: 412-246-5006
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place