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Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence

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ClinicalTrials.gov Identifier: NCT02202499
Recruitment Status : Completed
First Posted : July 29, 2014
Results First Posted : July 25, 2019
Last Update Posted : November 27, 2020
Sponsor:
Collaborators:
James and Esther King Biomedical Research Program
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Smoking Cessation
Tobacco Dependence
Interventions Drug: Varenicline
Other: Counseling and Support Materials
Other: Laboratory Assessments
Enrollment 86
Recruitment Details Daily cigarette smokers were recruited from the community for a smoking cessation intervention study, from July 2014 through August 2015, by Moffitt Cancer Center in Tampa, Florida.
Pre-assignment Details 86 interested parties were consented, 1 later declined, 23 did not meet criteria. 62 were eligible, 3 discontinued due to factors unrelated to study, 1 failed to attend first assessment. 58 parties participated in the study.
Arm/Group Title Extended Varenicline + Facilitated Extinction Standard Varenicline Extended Varenicline
Hide Arm/Group Description Active Comparator: Extended Varenicline + Facilitated Extinction. Active Comparator: Standard Varenicline (SV). Active Comparator: Extended Varenicline (EV).
Period Title: Overall Study
Started 21 20 21
Completed 19 20 19
Not Completed 2 0 2
Reason Not Completed
Cancer diagnosis             0             0             1
Moved from area             0             0             1
Declined before randomization             1             0             0
Auto accident             1             0             0
Arm/Group Title Extended Varenicline + Facilitated Extinction Standard Varenicline Extended Varenicline Total
Hide Arm/Group Description Active Comparator: Extended Varenicline + Facilitated Extinction. Active Comparator: Standard Varenicline (SV). Active Comparator: Extended Varenicline (EV). Total of all reporting groups
Overall Number of Baseline Participants 19 20 19 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 20 participants 19 participants 58 participants
51.2  (50.5) 51.9  (11.0) 48.4  (11.4) 50.5  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 19 participants 58 participants
Female
7
  36.8%
9
  45.0%
9
  47.4%
25
  43.1%
Male
12
  63.2%
11
  55.0%
10
  52.6%
33
  56.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 20 participants 19 participants 58 participants
19 20 19 58
1.Primary Outcome
Title Rate of Participant Retention
Hide Description Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).
Time Frame End of post treatment follow-up period of 3 months - approximately 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed 3 month post treatment follow up, regardless of study arm
Arm/Group Title Extended Varenicline + Facilitated Extinction Standard Vareniclline Extended Varenicline
Hide Arm/Group Description:
All participants who received Extended Varenicline + Facilitated Extinction
All participants who received Standard Varenicline (SV)
All participants who received Extended Varenicline
Overall Number of Participants Analyzed 19 20 19
Measure Type: Count of Participants
Unit of Measure: Participants
15
  78.9%
16
  80.0%
19
 100.0%
2.Secondary Outcome
Title Client Satisfaction Questionnaire (CSQ) Results
Hide Description Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison & Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score.
Time Frame One month post treatment - approximately 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended Varenicline + Facilitated Extinction Standard Vareniclline Extended Varenicline
Hide Arm/Group Description:
All participants who received Extended Varenicline +Facilitated Extinction
All participants who received Standard Varenicline
All participants who received Extended Varenicline
Overall Number of Participants Analyzed 19 20 19
Mean (Full Range)
Unit of Measure: units on a scale
30.33
(23 to 32)
30.80
(27 to 32)
30.47
(25 to 32)
3.Secondary Outcome
Title Rate of Intervention Adherence - Medication
Hide Description Percent of participants still using varenicline at time of analysis.
Time Frame One month post treatment - approximately 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Extended Varenicline + Facilitated Extinction Standard Varenicline Extended Varenicline
Hide Arm/Group Description:
Active Comparator: Extended Varenicline + Facilitated Extinction.
Active Comparator: Standard Varenicline (SV).
Active Comparator: Extended Varenicline (EV).
Overall Number of Participants Analyzed 19 20 19
Measure Type: Number
Unit of Measure: percentage of participants
80 80 84
4.Secondary Outcome
Title Average Intervention Adherence - Cigarettes Per Day (CPD)
Hide Description Average Cigarettes per Day across group, during last week of treatment.
Time Frame During last week of treatment, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Extended Varenicline + Facilitated Extinction Standard Varenicline Extended Varenicline
Hide Arm/Group Description:
Active Comparator: Extended Varenicline + Facilitated Extinction.
Active Comparator: Standard Varenicline (SV).
Active Comparator: Extended Varenicline (EV).
Overall Number of Participants Analyzed 19 20 19
Mean (Standard Deviation)
Unit of Measure: cigarettes per day
17.58  (5.85) 14.95  (9.06) 11.05  (6.16)
5.Secondary Outcome
Title Mean Peak Craving Score Per Group
Hide Description Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was "none", 5 "medium" and 10 "very high/strong"
Time Frame Across 4 pre-quit weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Extended Varenicline + Facilitated Extinction Standard Varenicline Extended Varenicline
Hide Arm/Group Description:
Active Comparator: Extended Varenicline + Facilitated Extinction.
Active Comparator: Standard Varenicline (SV).
Active Comparator: Extended Varenicline (EV).
Overall Number of Participants Analyzed 19 20 19
Mean (Standard Error)
Unit of Measure: units on a scale
4.64  (0.56) 6.34  (0.49) 4.56  (0.34)
6.Secondary Outcome
Title Mean Smoking Satisfaction Score Per Group
Hide Description Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was "none", 5 "medium" and 10 "very high"
Time Frame Across 4 pre-quit weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title Extended Varenicline + Facilitated Extinction Standard Varenicline Extended Varenicline
Hide Arm/Group Description:
Active Comparator: Extended Varenicline + Facilitated Extinction.
Active Comparator: Standard Varenicline (SV).
Active Comparator: Extended Varenicline (EV).
Overall Number of Participants Analyzed 19 20 19
Mean (Standard Error)
Unit of Measure: units on a scale
3.37  (0.64) 5.22  (067) 2.59  (0.40)
Time Frame 15 weeks
Adverse Event Reporting Description Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
 
Arm/Group Title Extended Varenicline + Facilitated Extinction Standard Varenicline Extended Varenicline
Hide Arm/Group Description Active Comparator: Extended Varenicline + Facilitated Extinction. Active Comparator: Standard Varenicline (SV). Active Comparator: Extended Varenicline (EV).
All-Cause Mortality
Extended Varenicline + Facilitated Extinction Standard Varenicline Extended Varenicline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/20 (0.00%)      0/19 (0.00%)    
Hide Serious Adverse Events
Extended Varenicline + Facilitated Extinction Standard Varenicline Extended Varenicline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      1/20 (5.00%)      0/19 (0.00%)    
Cardiac disorders       
Cardiac Disorders - Other * 1  0/19 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Gastrointestinal disorders       
Abdominal Pain * 1  0/19 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Esophageal Ulcer * 1  0/19 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Hepatobiliary disorders       
Gallblader Pain * 1  0/19 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Injury, poisoning and procedural complications       
Fracture * 1  1/19 (5.26%)  1 0/20 (0.00%)  0 0/19 (0.00%)  0
Vascular access complication * 1  1/19 (5.26%)  1 0/20 (0.00%)  0 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Joint range of motion decreased lumbar spine * 1  1/19 (5.26%)  1 0/20 (0.00%)  0 0/19 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Extended Varenicline + Facilitated Extinction Standard Varenicline Extended Varenicline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/20 (0.00%)      0/19 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Thomas Brandon
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-1750
EMail: thomas.brandon@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02202499    
Other Study ID Numbers: MCC-17654
First Submitted: July 22, 2014
First Posted: July 29, 2014
Results First Submitted: October 26, 2017
Results First Posted: July 25, 2019
Last Update Posted: November 27, 2020