NCT04188106

Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Rose Research Center, LLC · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Cessation
• Stress
• Sleep Disturbance
• Nausea

Interventions

Type	Name	Description
DRUG	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
DRUG	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.

Timeline

• Start date: 2019-06-17
• Primary completion: 2019-12-15
• Completion: 2019-12-15
• First posted: 2019-12-05
• Last updated: 2023-03-03
• Results posted: 2023-03-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study