Effects of Random Nicotine Delivery on Smoking Cessation

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

March 12, 2019

Primary Completion Date

November 25, 2019

Study Completion Date

November 25, 2019

Conditions
Smoking CessationCigarette SmokingSmoking (Tobacco) Addiction
Interventions
DRUG

Nicotine Film

"Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."

Trial Locations (1)

17033

Penn State Health Milton S. Hershey Medical Center, Hershey

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Milton S. Hershey Medical Center

OTHER

NCT03674970 - Effects of Random Nicotine Delivery on Smoking Cessation | Biotech Hunter | Biotech Hunter