Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)

PHASE2TerminatedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

January 7, 2020

Primary Completion Date

February 7, 2022

Study Completion Date

February 7, 2022

Conditions
Smoking Cessation
Interventions
DRUG

Varenicline

All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.

DRUG

Oral Nicotine Replacement Therapy (NRT)

Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.

BEHAVIORAL

Medication Reminders

Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.

BEHAVIORAL

Tobacco Cessation Counseling

All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.

Trial Locations (1)

73104

TSET Health Promotion Research Center, Oklahoma City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

University of Oklahoma

OTHER

NCT03722966 - Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO) | Biotech Hunter | Biotech Hunter