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Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation (ConNicBrain)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01406223
First Posted: August 1, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University
Results First Submitted: July 31, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Nicotine Dependence
Interventions: Drug: Varenicline
Drug: Bupropion
Drug: Nicotine patches
Other: Placebo varenicline
Other: Placebo bupropion
Other: Placebo patch

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 282 participants who were consented and screened, 191 were screen fails, 2 withdrew voluntarily before being assigned to a study arm, and 13 were lost to contact between screening and the first study visit. Therefore, only 76 participants were randomized and started the study.

Reporting Groups
  Description
Varenicline

For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.

Varenicline

Nicotine patches

Placebo bupropion

Placebo patch

NRT (Nicotine Patches Only)

21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.

Nicotine patches

Placebo varenicline

Placebo bupropion

Varenicline + Bupropion

For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.

Varenicline

Bupropion

Nicotine patches

Placebo patch

Post-quit NRT

Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.

Nicotine patches

Placebo varenicline

Placebo bupropion

Placebo patch


Participant Flow:   Overall Study
    Varenicline   NRT (Nicotine Patches Only)   Varenicline + Bupropion   Post-quit NRT
STARTED   18   19   20   19 
COMPLETED   6   7   2   3 
NOT COMPLETED   12   12   18   16 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Varenicline

For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches.

Varenicline

Nicotine patches

Placebo bupropion

Placebo patch

NRT (Nicotine Patches Only)

21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.

Nicotine patches

Placebo varenicline

Placebo bupropion

Varenicline + Bupropion

For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches.

Varenicline

Bupropion

Nicotine patches

Placebo patch

Post-quit NRT

Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline.

Nicotine patches

Placebo varenicline

Placebo bupropion

Placebo patch

Total Total of all reporting groups

Baseline Measures
   Varenicline   NRT (Nicotine Patches Only)   Varenicline + Bupropion   Post-quit NRT   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   19   20   19   76 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      18 100.0%      18  94.7%      20 100.0%      19 100.0%      75  98.7% 
>=65 years      0   0.0%      1   5.3%      0   0.0%      0   0.0%      1   1.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.56  (10.68)   41.89  (12.22)   38.35  (11.42)   37.16  (10.59)   38.75  (11.19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      11  61.1%      11  57.9%      8  40.0%      10  52.6%      40  52.6% 
Male      7  38.9%      8  42.1%      12  60.0%      9  47.4%      36  47.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      2  11.1%      1   5.3%      2  10.0%      0   0.0%      5   6.6% 
Not Hispanic or Latino      16  88.9%      18  94.7%      18  90.0%      19 100.0%      71  93.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      1   5.3%      0   0.0%      0   0.0%      1   1.3% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      12  66.7%      6  31.6%      9  45.0%      7  36.8%      34  44.7% 
White      5  27.8%      11  57.9%      10  50.0%      12  63.2%      38  50.0% 
More than one race      1   5.6%      1   5.3%      1   5.0%      0   0.0%      3   3.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   18   19   20   19   76 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences   [ Time Frame: change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) images collected during a cue-reactivity task following 2 weeks of pre-quit treatment ]

2.  Secondary:   Days to First Cigarette Following Quitting Smoking   [ Time Frame: 11 weeks post quit day. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Statistical comparisons of imaging data between groups are limited due to small sample size in each condition.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Principal Investigator
Organization: Duke University Medical Center
phone: 919-668-3987
e-mail: francis.mcclernon@duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01406223     History of Changes
Other Study ID Numbers: Pro00028331
1P50DA027840-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 12, 2011
First Posted: August 1, 2011
Results First Submitted: July 31, 2017
Results First Posted: August 31, 2017
Last Update Posted: October 12, 2017