Comparing NicoBloc to Nicotine Lozenges

• Status: Completed
• Trial end date: 2021-03-03
• Target enrollment: 0
• Participant gender: All

Summary

To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Nicotine

Criteria

Inclusion Criteria:

1. 18 years or older

2. planning to live in the Birmingham Metro area for the next 3 months

3. Smoking at least 5 cigarettes per day for the past year and a Carbon Monoxide>8ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation of enrolling a large >50% African-American average <10 cigarettes per day compared to Whites who average ~15 cigarettes per day

4. exclusive use of filtered cigarettes

5. English speaking.

Exclusion Criteria:

1. Living in a restricted environment that does not allow smoking (e.g., prison or jail facility, etc.)

2. Pregnant or nursing (all women of childbearing potential will be required to use an acceptable form of contraception)

3. Currently enrolled in a smoking cessation treatment program, using nicotine replacement products, or prescribed bupropion or varenicline

4. Known allergy nicotine lozenge

5. Within one month post-myocardial infarction or untreated severe angina

6. Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included)

7. Daily or exclusive use of other tobacco products (e.g., electronic cigarettes, little cigars, etc.).