Trial · NCT04188106
Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
NCT04188106, Phase 4, Completed, Rose Research Center, LLC; results first posted 2023-03-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment. Trials, record NCT04188106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04188106
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
- NCT number
- NCT04188106
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 26 participants, actual
- Lead sponsor
- Rose Research Center, LLC
- Conditions
- Smoking Cessation, Stress, Sleep Disturbance, Nausea
- Interventions
- Varenicline Pill, Hydroxyzine Pill
- First posted
- 2019-12-05
- Last updated
- 2023-03-03
- Results first posted
- 2023-03-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine). | Weeks 1, 2, 4, 8, 12 | 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. |
| Primary | Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI) | Weeks 1, 2, 4, 8, 12 | 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. |
| Primary | Changes in Depression Using the Patient Health Questionnaire (PHQ-9) | Weeks 1, 2, 4, 8, 12 | 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 |
| Secondary | Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date | 7 Days | 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. |
| Secondary | Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date | 7 Days | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine). | Weeks 1, 2, 4, 8, 12 | The number of participants changes based on dropouts. | score on a scale | MEAN |
| PRIMARY | Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI) | Weeks 1, 2, 4, 8, 12 | The number of participants changes based on dropouts. | score on a scale | MEAN |
| PRIMARY | Changes in Depression Using the Patient Health Questionnaire (PHQ-9) | Weeks 1, 2, 4, 8, 12 | The number of participants changes based on dropouts. | score on a scale | MEAN |
| SECONDARY | Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date | 7 Days | The participants are divided as to whether they were successful in quitting smoking combustible cigarettes. | Cigs smoked per day | MEAN |
| SECONDARY | Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date | 7 Days | The participants are divided as to whether they were successful in quitting smoking combustible cigarettes. | CO in ppm | MEAN |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine). | Hydroxyzine and Varenicline | Change in PPS-10 from BL to Week 1 | -1.38 | Standard Deviation 2.37 | score on a scale |
| Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine). | Hydroxyzine and Varenicline | Change in PPS-10 from BL to Week 2 | -1.48 | Standard Deviation 3 | score on a scale |
| Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine). | Hydroxyzine and Varenicline | Change in PPS-10 from BL to Week 4 | -1.55 | Standard Deviation 2.65 | score on a scale |
| Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine). | Hydroxyzine and Varenicline | Change in PPS-10 from BL to Week 8 | -2.05 | Standard Deviation 3.58 | score on a scale |
| Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine). | Hydroxyzine and Varenicline | Change in PPS-10 from BL to Week 12 | -2.75 | Standard Deviation 3.43 | score on a scale |
| Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI) | Hydroxyzine and Varenicline | Change in STAI from BL to Week 1 | -0.54 | Standard Deviation 2.67 | score on a scale |
| Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI) | Hydroxyzine and Varenicline | Change in STAI from BL to Week 2 | -1.09 | Standard Deviation 3.79 | score on a scale |
| Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI) | Hydroxyzine and Varenicline | Change in STAI from BL to Week 4 | -0.86 | Standard Deviation 4.54 | score on a scale |
| Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI) | Hydroxyzine and Varenicline | Change in STAI from BL to Week 8 | -1.82 | Standard Deviation 3.35 | score on a scale |
| Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI) | Hydroxyzine and Varenicline | Change in STAI from BL to Week 12 | -1.65 | Standard Deviation 3.59 | score on a scale |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydroxyzine and Varenicline | 26 | |
| Overall Study | COMPLETED | Hydroxyzine and Varenicline | 20 | |
| Overall Study | NOT COMPLETED | Hydroxyzine and Varenicline | 6 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypersomnolence | Nervous system disorders | Hydroxyzine and Varenicline | 9 | 26 | 11 |
| other | Nausea | Gastrointestinal disorders | Hydroxyzine and Varenicline | 10 | 26 | 10 |
| other | Insomnia | Nervous system disorders | Hydroxyzine and Varenicline | 9 | 26 | 9 |
| other | Mood Changes | Psychiatric disorders | Hydroxyzine and Varenicline | 7 | 26 | 7 |
| other | Headache | Nervous system disorders | Hydroxyzine and Varenicline | 5 | 26 | 5 |
| other | Elevated blood pressure | Cardiac disorders | Hydroxyzine and Varenicline | 4 | 26 | 4 |
| other | Vivid dreams | Nervous system disorders | Hydroxyzine and Varenicline | 4 | 26 | 4 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydroxyzine and Varenicline | 0 | 26 |
| Total, other adverse events | Hydroxyzine and Varenicline | 21 | 26 |
| Total, serious adverse events | Hydroxyzine and Varenicline | 0 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04188106
GET https://conductscience.org/api/trials/v1/NCT04188106/registered