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Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder (BEST)

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ClinicalTrials.gov Identifier: NCT01010204
Recruitment Status : Completed
First Posted : November 9, 2009
Results First Posted : March 12, 2015
Last Update Posted : December 4, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Pfizer
Information provided by (Responsible Party):
K.N. Roy Chengappa, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Smoking Cessation
Bipolar Disorder
Interventions Drug: Varenicline
Drug: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 31 29
Completed 24 20
Not Completed 7 9
Reason Not Completed
Lost to Follow-up             2             2
Adverse Event             1             3
Withdrawal by Subject             2             3
psychiatric hospitalization             2             1
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 31 29 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 29 participants 60 participants
45.7  (10.3) 46.2  (8.5) 45.95  (9.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
Female
22
  71.0%
19
  65.5%
41
  68.3%
Male
9
  29.0%
10
  34.5%
19
  31.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  35.5%
8
  27.6%
19
  31.7%
White
20
  64.5%
21
  72.4%
41
  68.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks
Hide Description To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
bipolar subjects
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 29
Measure Type: Number
Unit of Measure: participants
15 3
2.Primary Outcome
Title 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks
Hide Description To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
bipolar patients
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 29
Measure Type: Number
Unit of Measure: participants
6 2
3.Secondary Outcome
Title Participants Experiencing Neuropsychiatric Events
Hide Description 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.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Bipolar Patients
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 29
Measure Type: Count of Participants
Unit of Measure: Participants
7
  22.6%
2
   6.9%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/31 (19.35%)      4/29 (13.79%)    
Cardiac disorders     
chest pain, left hand numbness *  0/31 (0.00%)  0 1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders     
upper left arm weakness *  1/31 (3.23%)  1 0/29 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
pregnancy *  0/31 (0.00%)  0 1/29 (3.45%)  1
Psychiatric disorders     
exacerbation of anxiety *  1/31 (3.23%)  1 0/29 (0.00%)  0
agitation, hostility, alcohol drug abuse *  1/31 (3.23%)  1 0/29 (0.00%)  0
alcohol intoxication *  0/31 (0.00%)  0 1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders     
asthma with acute exacerbation *  1/31 (3.23%)  1 1/29 (3.45%)  1
pneumonia *  1/31 (3.23%)  1 0/29 (0.00%)  0
Skin and subcutaneous tissue disorders     
rash *  1/31 (3.23%)  1 0/29 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/31 (93.55%)      25/29 (86.21%)    
Gastrointestinal disorders     
diarrhea *  2/31 (6.45%)  2 3/29 (10.34%)  3
constipation *  7/31 (22.58%)  7 5/29 (17.24%)  5
flatulance *  11/31 (35.48%)  11 11/29 (37.93%)  11
vomiting *  3/31 (9.68%)  3 6/29 (20.69%)  6
nausea *  13/31 (41.94%)  13 9/29 (31.03%)  9
heart burn *  7/31 (22.58%)  7 6/29 (20.69%)  6
abdominal pain *  6/31 (19.35%)  6 6/29 (20.69%)  6
gastroesophageal reflux *  7/31 (22.58%)  7 2/29 (6.90%)  2
General disorders     
dry mouth *  9/31 (29.03%)  9 9/29 (31.03%)  9
fatigue/lethargy *  8/31 (25.81%)  8 5/29 (17.24%)  5
asthenia-weakness *  1/31 (3.23%)  1 4/29 (13.79%)  4
Metabolism and nutrition disorders     
increased appetite *  7/31 (22.58%)  7 6/29 (20.69%)  6
decreased appetite *  8/31 (25.81%)  8 6/29 (20.69%)  6
weight gain *  2/31 (6.45%)  2 2/29 (6.90%)  2
weight loss *  2/31 (6.45%)  2 1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders     
arthralgia/pain *  2/31 (6.45%)  2 2/29 (6.90%)  2
Nervous system disorders     
somnolence *  2/31 (6.45%)  2 1/29 (3.45%)  1
headache *  11/31 (35.48%)  11 12/29 (41.38%)  12
dizziness *  2/31 (6.45%)  2 1/29 (3.45%)  1
bad taste *  4/31 (12.90%)  4 2/29 (6.90%)  2
Psychiatric disorders     
depressed mood *  8/31 (25.81%)  8 2/29 (6.90%)  2
anxiety *  2/31 (6.45%)  2 0/29 (0.00%)  0
mood swings *  2/31 (6.45%)  2 1/29 (3.45%)  1
insomnia *  14/31 (45.16%)  14 8/29 (27.59%)  8
abnormal dreams *  18/31 (58.06%)  18 9/29 (31.03%)  9
suicidal ideation *  2/31 (6.45%)  2 1/29 (3.45%)  1
Renal and urinary disorders     
urinary tract infection *  2/31 (6.45%)  2 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
runny nose *  6/31 (19.35%)  6 6/29 (20.69%)  6
shortness of breath *  4/31 (12.90%)  4 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders     
rash *  3/31 (9.68%)  3 2/29 (6.90%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: K.N. Roy Chengappa, Md
Organization: Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center
Phone: 412-246-5006
Responsible Party: K.N. Roy Chengappa, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01010204     History of Changes
Other Study ID Numbers: R21MH087928 ( U.S. NIH Grant/Contract )
R21MH087928 ( U.S. NIH Grant/Contract )
First Submitted: November 5, 2009
First Posted: November 9, 2009
Results First Submitted: February 27, 2015
Results First Posted: March 12, 2015
Last Update Posted: December 4, 2017