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NCT04188106 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
A Phase 4 study, sponsored by Rose Research Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT04188106: Completed Phase 4 study, sponsored by Rose Research Center.
NCT04188106 is a Phase 4 study that has completed, run by Rose Research Center. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04188106, a Phase 4 study, has completed, sponsored by Rose Research Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
This open-label study will evaluate hydroxyzine, a first-generation antihistamine, combined with varenicline, to help smokers abstain from smoking during a 12-week trial period by diminishing the nausea, stress, anxiety, and sleep disturbances associated with the use of varenicline and with nicotine withdrawal.
Primary Outcome
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.
Interventions
- DRUG Varenicline Pill
- DRUG Hydroxyzine Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-06-17 |
| Est. Completion | 2019-12-15 |
| Phase | Phase 4 |
What the finished NCT04188106 record still lists
NCT04188106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Varenicline Pill is the first listed.
NCT04188106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04188106 about?
NCT04188106 is a clinical study titled "Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment". This open-label study will evaluate hydroxyzine, a first-generation antihistamine, combined with varenicline, to help smokers abstain from smoking during a 12-week trial period by diminishing the nausea, stress, anxiety, and sleep disturbances associated with the use of varenicline and with nicotine...
What is the current status of trial NCT04188106?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2019-06-17. Estimated completion is 2019-12-15.
What interventions are being tested in trial NCT04188106?
The interventions under investigation include: Varenicline Pill (DRUG), Hydroxyzine Pill (DRUG).
Who is sponsoring clinical trial NCT04188106?
This trial is sponsored by Rose Research Center, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04188106's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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