Trial Outcomes & Findings for Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence (NCT NCT03538808)
NCT ID: NCT03538808
Last Updated: 2020-12-14
Results Overview
Self-reported medication adherence measured through a single item assessing medication compliance. The item is answered as "yes" (scored as 1) or "no" (scored as 0). This measure combines all responses from Day 1 through Day 13 of this study to provide a total measure of medication adherence ranging from 0% (missed all doses) to 100% (took every dose as prescribed). Higher scores indicate better outcomes (i.e., better adherence to medication).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
Days 1 - 13
Results posted on
2020-12-14
Participant Flow
None, all participants that were enrolled in the study were randomized into one of the four conditions.
Participant milestones
| Measure |
Therapeutic Dose/Varenicline
Participants were told they were provided with a therapeutic dose of varenicline and they received varenicline medication
|
Therapeutic Dose/Placebo
Participants were told they received a therapeutic dose varenicline, but they received a placebo.
|
Low Dose/Varenicline
Participants were told they received a very low dose varenicline, but they received a therapeutic dose varenicline.
|
Low Dose/Placebo
Participants were told they received a very low dose varenicline, but they received a placebo.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
20
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence
Baseline characteristics by cohort
| Measure |
Therapeutic Dose/Varenicline
n=20 Participants
Participants were told they were provided with a therapeutic dose of varenicline and they received varenicline medication.
|
Therapeutic Dose/Placebo
n=20 Participants
Participants were told they received a therapeutic dose varenicline, but they received a placebo.
|
Low Dose/Varenicline
n=20 Participants
Participants were told they received a very low dose varenicline, but they received a therapeutic dose varenicline.
|
Low Dose/Placebo
n=20 Participants
Participants were told they received a very low dose varenicline, but they received a placebo.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.15 years
STANDARD_DEVIATION 2.59 • n=5 Participants
|
48.00 years
STANDARD_DEVIATION 2.59 • n=7 Participants
|
45.00 years
STANDARD_DEVIATION 2.59 • n=5 Participants
|
45.30 years
STANDARD_DEVIATION 2.59 • n=4 Participants
|
46.86 years
STANDARD_DEVIATION 11.51 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Stanford Expectations of Treatment Scale: Negative Subscale
|
3.42 units on a scale
STANDARD_DEVIATION 0.34 • n=5 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 0.34 • n=7 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 0.34 • n=5 Participants
|
3.3 units on a scale
STANDARD_DEVIATION 0.34 • n=4 Participants
|
3.33 units on a scale
STANDARD_DEVIATION 1.48 • n=21 Participants
|
PRIMARY outcome
Timeframe: Days 1 - 13Self-reported medication adherence measured through a single item assessing medication compliance. The item is answered as "yes" (scored as 1) or "no" (scored as 0). This measure combines all responses from Day 1 through Day 13 of this study to provide a total measure of medication adherence ranging from 0% (missed all doses) to 100% (took every dose as prescribed). Higher scores indicate better outcomes (i.e., better adherence to medication).
Outcome measures
| Measure |
Therapeutic Dose/Varenicline
n=18 Participants
Participants were told they were provided with a therapeutic dose of varenicline and they received varenicline medication.
|
Therapeutic Dose/Placebo
n=20 Participants
Participants were told they received a therapeutic dose varenicline, but they received a placebo.
|
Low Dose/Varenicline
n=16 Participants
Participants were told they received a very low dose varenicline, but they received a therapeutic dose varenicline.
|
Low Dose/Placebo
n=18 Participants
Participants were told they received a very low dose varenicline, but they received a placebo.
|
|---|---|---|---|---|
|
Medication Adherence
|
85.36 Percentage
|
86.79 Percentage
|
81.93 Percentage
|
86.09 Percentage
|
SECONDARY outcome
Timeframe: Baseline and Day 14Medication expectancies will be measured through the Beliefs and Attitudes about Varenicline (BAV) scale which is a 6-item questionnaire adapted to assess varenicline expectancies. This measure is rated on a scale from 1 (not at all) to 5 (extremely). The measure has a minimum score of 6 and a maximum score of 30. Higher scores indicating better outcomes (i.e., stronger positive beliefs about using varenicline).
Outcome measures
| Measure |
Therapeutic Dose/Varenicline
n=18 Participants
Participants were told they were provided with a therapeutic dose of varenicline and they received varenicline medication.
|
Therapeutic Dose/Placebo
n=20 Participants
Participants were told they received a therapeutic dose varenicline, but they received a placebo.
|
Low Dose/Varenicline
n=16 Participants
Participants were told they received a very low dose varenicline, but they received a therapeutic dose varenicline.
|
Low Dose/Placebo
n=18 Participants
Participants were told they received a very low dose varenicline, but they received a placebo.
|
|---|---|---|---|---|
|
Medication Expectancies
|
3.56 units on a scale
Interval 3.06 to 3.94
|
3.65 units on a scale
Interval 3.12 to 4.18
|
3.50 units on a scale
Interval 2.91 to 4.09
|
3.44 units on a scale
Interval 2.89 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14A 30-item self-report measure of the presence (or not) of symptoms commonly associated with varenicline side effects and nicotine withdrawal. Items are rated as "No" (scored as 0) or "Yes" (scored as 1). A total score was calculated to reflect the total number of reported side effects. This measure has a minimum score of 0 and a maximum score of 30. Higher scores indicate worse outcomes (i.e., greater frequency of experienced side effects).
Outcome measures
| Measure |
Therapeutic Dose/Varenicline
n=18 Participants
Participants were told they were provided with a therapeutic dose of varenicline and they received varenicline medication.
|
Therapeutic Dose/Placebo
n=20 Participants
Participants were told they received a therapeutic dose varenicline, but they received a placebo.
|
Low Dose/Varenicline
n=16 Participants
Participants were told they received a very low dose varenicline, but they received a therapeutic dose varenicline.
|
Low Dose/Placebo
n=18 Participants
Participants were told they received a very low dose varenicline, but they received a placebo.
|
|---|---|---|---|---|
|
Side Effects
|
1.50 Symptoms
Standard Error 0.57
|
3.40 Symptoms
Standard Error 0.54
|
2.00 Symptoms
Standard Error 0.61
|
1.89 Symptoms
Standard Error 0.57
|
Adverse Events
Therapeutic Dose/Varenicline
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Therapeutic Dose/Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Low Dose/Varenicline
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Low Dose/Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Therapeutic Dose/Varenicline
n=20 participants at risk
Participants were told they were provided with a therapeutic dose of varenicline and they received varenicline medication.
|
Therapeutic Dose/Placebo
n=20 participants at risk
Participants were told they received a therapeutic dose varenicline, but they received a placebo.
|
Low Dose/Varenicline
n=20 participants at risk
Participants were told they received a very low dose varenicline, but they received a therapeutic dose varenicline.
|
Low Dose/Placebo
n=20 participants at risk
Participants were told they received a very low dose varenicline, but they received a placebo.
|
|---|---|---|---|---|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
|
Psychiatric disorders
Nocebo Effect/Depressed Mood
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
|
Renal and urinary disorders
Nocebo Effect/Sexual Dysfunction
|
0.00%
0/20 • 14 days
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
|
Surgical and medical procedures
Nasal Polyp Removal
|
5.0%
1/20 • Number of events 1 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
0.00%
0/20 • 14 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place