Comparing NicoBloc to Nicotine Lozenges

Smoking Cessation Clinical Trial

Official title:

A Pilot Trial Comparing NicoBloc to Nicotine Lozenges: Initial Acceptability and Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720899
• Other study ID #: 300001370
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 21, 2019
• Est. completion date: March 3, 2021

Study information

• Verified date: March 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 3, 2021
• Est. primary completion date: January 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Drug:
• NicoBloc
For Session 1, participants will use one drop of NicoBloc (which will block 33% of tar and nicotine) on their conventional cigarette and then will smoke this cigarette in session. Following smoking, they will discuss the effects of the NicoBloc on their withdrawal, cravings, and overall enjoyment of their cigarette. To bolster their in vivo NicoBloc experience, participants will be provided with NicoBloc to use between sessions to acclimate to the NicoBloc and to make practice quit attempts (PQAs). Sessions 2 and 3 are similar to Session 1 except they will use more NicoBloc product during the session and will be instructed to use the product between sessions.
• Nicotine Lozenge
Participants who receive nicotine lozenge (mini lozenge) will be given either a 2 or 4 mg lozenge to use in session, depending on how soon they smoke after waking. If a participant smokes within 30 minutes of waking, they start with the 4 mg lozenge; more than 30 minutes, they start with the 2 mg lozenge. They will be given lozenges between sessions to make PQAs.

Locations

Country	Name	City	State
United States	University of Alabama, Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Treatment Satisfaction Survey	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	4 months
Secondary	Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint	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	Week 4
Secondary	Retention Rates	The total number of participants retained throughout the entirety of the study duration.	4 months