Comparing NicoBloc to Nicotine Lozenges

Phase 2

Completed

• Conditions: Smoking Cessation; Nicotine Dependence
• Interventions: Drug: NicoBloc; Drug: Nicotine Lozenge

• Registration Number: NCT03720899
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Study Start: 2019-03-21
• Primary Completion: 2021-01-03
• Study Completion: 2021-03-03
• Results First Submitted: 2022-02-02
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-30
• Last Update Submitted: 2022-03-30
• Results First Posted: 2022-04-04
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

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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.).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NicoBloc	NicoBloc	NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc.
Nicotine Lozenge	Nicotine Lozenge	Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session.

Primary Outcome Measures

Name	Time	Method
The Treatment Satisfaction Survey	4 months	* Number of items: 10; * Scale: 1 (not at all helpful) - 7 (very helpful), as well as "0" response for "Don't Know".; * Full-scale range: 0-70; * Interpretation: Higher scores indicate more treatment satisfaction Subscales: N/A

Secondary Outcome Measures

Name	Time	Method
Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint	Week 4	* Number of items: 10; * Scale: 1 (Strongly Disagree) - 7 (Strongly Agree); * Full-scale range: 10-70; * Interpretation: Higher scores indicate more smoking urges Subscales: N/A
Retention Rates	4 months	The total number of participants retained throughout the entirety of the study duration.

Trial Locations

Locations (1)

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States