Trial Outcomes & Findings for Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment (NCT NCT04188106)
NCT ID: NCT04188106
Last Updated: 2023-03-03
Results Overview
Stress levels in the last 30 days will be measured using the 10-item Perceived Stress Scale (PSS-10). The PSS-10 uses a 5-point scale (0 - never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). Total scores range from 0 to 40. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Weeks 1, 2, 4, 8, 12
Results posted on
2023-03-03
Participant Flow
The study was conducted in both the Raleigh, NC and Charlotte, NC offices of Rose Research Center. Enrollment started on 17 June 2019 and ended on 16 September 2019.
Participant milestones
| Measure |
Hydroxyzine and Varenicline
Participants enrolled in the study will take the FDA approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Hydroxyzine and Varenicline
Participants enrolled in the study will take the FDA approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
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|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Non-Compliance
|
1
|
Baseline Characteristics
Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
Baseline characteristics by cohort
| Measure |
Hydroxyzine and Varenicline
n=26 Participants
Participants enrolled in the study will take the FDA approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning and 50 mg at nighttime. All medications will be dosed orally.
Varenicline Pill: FDA approved starter kit of varenicline (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) followed by FDA-approved dose of varenicline (1 mg twice daily) for the remaining 11 weeks
Hydroxyzine Pill: For the first week, participants will receive 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night for the remaining 12 weeks.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.115 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12Population: The number of participants changes based on dropouts.
Stress levels in the last 30 days will be measured using the 10-item Perceived Stress Scale (PSS-10). The PSS-10 uses a 5-point scale (0 - never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). Total scores range from 0 to 40. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.
Outcome measures
| Measure |
Hydroxyzine and Varenicline
n=24 Participants
Participants enrolled in the study will take the FDA approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
|
Hydroxyzine and Varenicline -- Unsuccessful in Quitting Smoking
Participants enrolled in the study will take the FDA-approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
|
|---|---|---|
|
Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine).
Change in PPS-10 from BL to Week 1
|
-1.38 score on a scale
Standard Deviation 2.37
|
—
|
|
Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine).
Change in PPS-10 from BL to Week 2
|
-1.48 score on a scale
Standard Deviation 3
|
—
|
|
Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine).
Change in PPS-10 from BL to Week 4
|
-1.55 score on a scale
Standard Deviation 2.65
|
—
|
|
Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine).
Change in PPS-10 from BL to Week 8
|
-2.05 score on a scale
Standard Deviation 3.58
|
—
|
|
Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine).
Change in PPS-10 from BL to Week 12
|
-2.75 score on a scale
Standard Deviation 3.43
|
—
|
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12Population: The number of participants changes based on dropouts.
Trait and state anxiety levels will be monitored for changes using the 6-item State-Trait Anxiety Inventory (STAI). All items are rated on a 4-point scale ("1-Almost Never" to "4-Almost Always"). The range of scores is from 6 to 24. Higher scores indicate greater anxiety.
Outcome measures
| Measure |
Hydroxyzine and Varenicline
n=24 Participants
Participants enrolled in the study will take the FDA approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
|
Hydroxyzine and Varenicline -- Unsuccessful in Quitting Smoking
Participants enrolled in the study will take the FDA-approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
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|---|---|---|
|
Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI)
Change in STAI from BL to Week 1
|
-0.54 score on a scale
Standard Deviation 2.67
|
—
|
|
Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI)
Change in STAI from BL to Week 2
|
-1.09 score on a scale
Standard Deviation 3.79
|
—
|
|
Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI)
Change in STAI from BL to Week 4
|
-0.86 score on a scale
Standard Deviation 4.54
|
—
|
|
Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI)
Change in STAI from BL to Week 8
|
-1.82 score on a scale
Standard Deviation 3.35
|
—
|
|
Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI)
Change in STAI from BL to Week 12
|
-1.65 score on a scale
Standard Deviation 3.59
|
—
|
PRIMARY outcome
Timeframe: Weeks 1, 2, 4, 8, 12Population: The number of participants changes based on dropouts.
Depression will be monitored for changes using the Patient Health Questionnaire (PHQ-9). The PHQ-9 uses a 4-point scale (Not at all = 0; Several days = 1;More than half the days = 2; Nearly every day = 3). The sum of the scores is calculated (Score range is 0 to 27): * 1-4 Minimal depression * 5-9 Mild depression * 10-14 Moderate depression * 15-19 Moderately severe depression * 20-27 Severe depression
Outcome measures
| Measure |
Hydroxyzine and Varenicline
n=24 Participants
Participants enrolled in the study will take the FDA approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
|
Hydroxyzine and Varenicline -- Unsuccessful in Quitting Smoking
Participants enrolled in the study will take the FDA-approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
|
|---|---|---|
|
Changes in Depression Using the Patient Health Questionnaire (PHQ-9)
Change in PHQ-9 from BL to Week 1
|
-0.15 score on a scale
Standard Deviation 1.12
|
—
|
|
Changes in Depression Using the Patient Health Questionnaire (PHQ-9)
Change in PHQ-9 from BL to Week 2
|
0.63 score on a scale
Standard Deviation 2.16
|
—
|
|
Changes in Depression Using the Patient Health Questionnaire (PHQ-9)
Change in PHQ-9 from BL to Week 4
|
0.43 score on a scale
Standard Deviation 2.95
|
—
|
|
Changes in Depression Using the Patient Health Questionnaire (PHQ-9)
Change in PHQ-9 from BL to Week 8
|
-0.27 score on a scale
Standard Deviation 2.07
|
—
|
|
Changes in Depression Using the Patient Health Questionnaire (PHQ-9)
Change in PHQ-9 from BL to Week 12
|
-0.41 score on a scale
Standard Deviation 1.87
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: The participants are divided as to whether they were successful in quitting smoking combustible cigarettes.
Previous research has shown that abstinence at the end of treatment is strongly predicted by the extent to which smokers spontaneously reduce ad libitum smoking in the initial weeks of pharmacotherapy that is initiated before the quit-smoking date. This measure will assess the extent of smoking reduction in participants during the initial seven days of treatment (prior to their planned quit date) - assessed via a self-report number of cigarettes per day. Data is recorded as a mean change.
Outcome measures
| Measure |
Hydroxyzine and Varenicline
n=7 Participants
Participants enrolled in the study will take the FDA approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
|
Hydroxyzine and Varenicline -- Unsuccessful in Quitting Smoking
n=19 Participants
Participants enrolled in the study will take the FDA-approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
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|---|---|---|
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Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date
|
-9.14 Cigs smoked per day
Standard Deviation 2.29
|
-5.53 Cigs smoked per day
Standard Deviation 6.80
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: The participants are divided as to whether they were successful in quitting smoking combustible cigarettes.
Previous research has shown that abstinence at the end of treatment is strongly predicted by the extent to which smokers spontaneously reduce ad libitum smoking in the initial weeks of pharmacotherapy that is initiated before the quit-smoking date. This measure will assess the extent of smoking reduction in participants during the initial seven days of treatment (prior to their planned quit date) - assessed via expired air carbon monoxide (CO). Data is recorded as a mean change.
Outcome measures
| Measure |
Hydroxyzine and Varenicline
n=7 Participants
Participants enrolled in the study will take the FDA approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
|
Hydroxyzine and Varenicline -- Unsuccessful in Quitting Smoking
n=19 Participants
Participants enrolled in the study will take the FDA-approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
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|---|---|---|
|
Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date
|
-11.00 CO in ppm
Standard Deviation 8.28
|
-2.12 CO in ppm
Standard Deviation 10.02
|
Adverse Events
Hydroxyzine and Varenicline
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hydroxyzine and Varenicline
n=26 participants at risk
Participants enrolled in the study will take the FDA approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning, and 50 mg at nighttime. All medications will be dosed orally.
|
|---|---|
|
Nervous system disorders
Hypersomnolence
|
34.6%
9/26 • Number of events 11 • Data were collected during the 12 week treatment period.
|
|
Gastrointestinal disorders
Nausea
|
38.5%
10/26 • Number of events 10 • Data were collected during the 12 week treatment period.
|
|
Nervous system disorders
Insomnia
|
34.6%
9/26 • Number of events 9 • Data were collected during the 12 week treatment period.
|
|
Psychiatric disorders
Mood Changes
|
26.9%
7/26 • Number of events 7 • Data were collected during the 12 week treatment period.
|
|
Nervous system disorders
Headache
|
19.2%
5/26 • Number of events 5 • Data were collected during the 12 week treatment period.
|
|
Cardiac disorders
Elevated blood pressure
|
15.4%
4/26 • Number of events 4 • Data were collected during the 12 week treatment period.
|
|
Nervous system disorders
Vivid dreams
|
15.4%
4/26 • Number of events 4 • Data were collected during the 12 week treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place