Comparing NicoBloc to Nicotine Lozenges

The University of Alabama at Birmingham

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nicotine Dependence; Smoking Cessation

Treatments: Drug: Nicotine Lozenge; Drug: NicoBloc

Study type: Interventional

Funder types: Other

Identifiers

NCT03720899

300001370

Details and patient eligibility

About

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

Full description

Smoking remains the leading cause of preventable death in the U.S. with approximately 18% of the population continuing to smoke. However, smoking is concentrated in disadvantaged populations where the prevalence of smoking may be as high as 70-80 %. Participants will receive a sampling experience (use of nicotine lozenges or NicoBloc during sessions) with counseling focused around their experience of using these interventions, including side effects and smoking cessation expectancies.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

NicoBloc

Experimental group

Description:

NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc.

Treatment:

Drug: NicoBloc

Nicotine Lozenge

Active Comparator group

Description:

Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session.

Treatment:

Drug: Nicotine Lozenge