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

PHASE4CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

June 17, 2019

Primary Completion Date

December 15, 2019

Study Completion Date

December 15, 2019

Conditions
Smoking CessationStressSleep DisturbanceNausea
Interventions
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.

Trial Locations (2)

27617

Rose Research Center, Raleigh

28262

Rose Research Center, Charlotte

All Listed Sponsors
collaborator

Foundation for a Smoke Free World INC

OTHER

lead

Rose Research Center, LLC

INDUSTRY

NCT04188106 - Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment | Biotech Hunter | Biotech Hunter