Trial Outcomes & Findings for Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence (NCT NCT02202499)
NCT ID: NCT02202499
Last Updated: 2020-11-27
Results Overview
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).
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
86 participants
Primary outcome timeframe
End of post treatment follow-up period of 3 months - approximately 28 weeks
Results posted on
2020-11-27
Participant Flow
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.
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.
Participant milestones
| Measure |
Extended Varenicline + Facilitated Extinction
Active Comparator: Extended Varenicline + Facilitated Extinction.
|
Standard Varenicline
Active Comparator: Standard Varenicline (SV).
|
Extended Varenicline
Active Comparator: Extended Varenicline (EV).
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
21
|
|
Overall Study
COMPLETED
|
19
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
Reasons for withdrawal
| Measure |
Extended Varenicline + Facilitated Extinction
Active Comparator: Extended Varenicline + Facilitated Extinction.
|
Standard Varenicline
Active Comparator: Standard Varenicline (SV).
|
Extended Varenicline
Active Comparator: Extended Varenicline (EV).
|
|---|---|---|---|
|
Overall Study
Cancer diagnosis
|
0
|
0
|
1
|
|
Overall Study
Moved from area
|
0
|
0
|
1
|
|
Overall Study
Declined before randomization
|
1
|
0
|
0
|
|
Overall Study
Auto accident
|
1
|
0
|
0
|
Baseline Characteristics
Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence
Baseline characteristics by cohort
| Measure |
Extended Varenicline + Facilitated Extinction
n=19 Participants
Active Comparator: Extended Varenicline + Facilitated Extinction.
|
Standard Varenicline
n=20 Participants
Active Comparator: Standard Varenicline (SV).
|
Extended Varenicline
n=19 Participants
Active Comparator: Extended Varenicline (EV).
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 50.5 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
58 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of post treatment follow-up period of 3 months - approximately 28 weeksPopulation: All participants who completed 3 month post treatment follow up, regardless of study arm
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).
Outcome measures
| Measure |
Extended Varenicline + Facilitated Extinction
n=19 Participants
All participants who received Extended Varenicline + Facilitated Extinction
|
Standard Vareniclline
n=20 Participants
All participants who received Standard Varenicline (SV)
|
Extended Varenicline
n=19 Participants
All participants who received Extended Varenicline
|
|---|---|---|---|
|
Rate of Participant Retention
|
15 Participants
|
16 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: One month post treatment - approximately 20 weeksAcceptability: 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.
Outcome measures
| Measure |
Extended Varenicline + Facilitated Extinction
n=19 Participants
All participants who received Extended Varenicline + Facilitated Extinction
|
Standard Vareniclline
n=20 Participants
All participants who received Standard Varenicline (SV)
|
Extended Varenicline
n=19 Participants
All participants who received Extended Varenicline
|
|---|---|---|---|
|
Client Satisfaction Questionnaire (CSQ) Results
|
30.33 units on a scale
Interval 23.0 to 32.0
|
30.80 units on a scale
Interval 27.0 to 32.0
|
30.47 units on a scale
Interval 25.0 to 32.0
|
SECONDARY outcome
Timeframe: One month post treatment - approximately 20 weeksPopulation: All participants.
Percent of participants still using varenicline at time of analysis.
Outcome measures
| Measure |
Extended Varenicline + Facilitated Extinction
n=19 Participants
All participants who received Extended Varenicline + Facilitated Extinction
|
Standard Vareniclline
n=20 Participants
All participants who received Standard Varenicline (SV)
|
Extended Varenicline
n=19 Participants
All participants who received Extended Varenicline
|
|---|---|---|---|
|
Rate of Intervention Adherence - Medication
|
80 percentage of participants
|
80 percentage of participants
|
84 percentage of participants
|
SECONDARY outcome
Timeframe: During last week of treatment, week 16Population: All participants.
Average Cigarettes per Day across group, during last week of treatment.
Outcome measures
| Measure |
Extended Varenicline + Facilitated Extinction
n=19 Participants
All participants who received Extended Varenicline + Facilitated Extinction
|
Standard Vareniclline
n=20 Participants
All participants who received Standard Varenicline (SV)
|
Extended Varenicline
n=19 Participants
All participants who received Extended Varenicline
|
|---|---|---|---|
|
Average Intervention Adherence - Cigarettes Per Day (CPD)
|
17.58 cigarettes per day
Standard Deviation 5.85
|
14.95 cigarettes per day
Standard Deviation 9.06
|
11.05 cigarettes per day
Standard Deviation 6.16
|
SECONDARY outcome
Timeframe: Across 4 pre-quit weeksPopulation: All participants.
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"
Outcome measures
| Measure |
Extended Varenicline + Facilitated Extinction
n=19 Participants
All participants who received Extended Varenicline + Facilitated Extinction
|
Standard Vareniclline
n=20 Participants
All participants who received Standard Varenicline (SV)
|
Extended Varenicline
n=19 Participants
All participants who received Extended Varenicline
|
|---|---|---|---|
|
Mean Peak Craving Score Per Group
|
4.64 units on a scale
Standard Error 0.56
|
6.34 units on a scale
Standard Error 0.49
|
4.56 units on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Across 4 pre-quit weeksPopulation: All participants.
Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was "none", 5 "medium" and 10 "very high"
Outcome measures
| Measure |
Extended Varenicline + Facilitated Extinction
n=19 Participants
All participants who received Extended Varenicline + Facilitated Extinction
|
Standard Vareniclline
n=20 Participants
All participants who received Standard Varenicline (SV)
|
Extended Varenicline
n=19 Participants
All participants who received Extended Varenicline
|
|---|---|---|---|
|
Mean Smoking Satisfaction Score Per Group
|
3.37 units on a scale
Standard Error 0.64
|
5.22 units on a scale
Standard Error 067
|
2.59 units on a scale
Standard Error 0.40
|
Adverse Events
Extended Varenicline + Facilitated Extinction
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Varenicline
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Extended Varenicline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Extended Varenicline + Facilitated Extinction
n=19 participants at risk
Active Comparator: Extended Varenicline + Facilitated Extinction.
|
Standard Varenicline
n=20 participants at risk
Active Comparator: Standard Varenicline (SV).
|
Extended Varenicline
n=19 participants at risk
Active Comparator: Extended Varenicline (EV).
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Disorders - Other
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
5.0%
1/20 • Number of events 1 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
5.0%
1/20 • Number of events 1 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
|
Gastrointestinal disorders
Esophageal Ulcer
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
5.0%
1/20 • Number of events 1 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
|
Hepatobiliary disorders
Gallblader Pain
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
5.0%
1/20 • Number of events 1 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
|
Injury, poisoning and procedural complications
Fracture
|
5.3%
1/19 • Number of events 1 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
0.00%
0/20 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
5.3%
1/19 • Number of events 1 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
0.00%
0/20 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased lumbar spine
|
5.3%
1/19 • Number of events 1 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
0.00%
0/20 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
0.00%
0/19 • 15 weeks
Adverse Events collected after start of Varenicline until end of treatment (15 weeks)
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Thomas Brandon
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-1750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place