drugset / Trial / NCT04188106
Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
Phase 4
Completed
26 enrolled
Rose Research Center, LLC
Foundation for a Smoke Free World INC · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-06-17
- Primary completion
- 2019-12-15
- Completion
- 2019-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxyzine | Small molecule | 25 mg | Oral |
| Subject | Hydroxyzine | Small molecule | 50 mg | Oral |
| Subject | Varenicline | Small molecule | 1 mg | Oral |