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Comparing NicoBloc to Nicotine Lozenges

Primary Purpose

Smoking Cessation, Nicotine Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

NicoBloc

Nicotine Lozenge

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years or older
planning to live in the Birmingham Metro area for the next 3 months
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
exclusive use of filtered cigarettes
English speaking.

Exclusion Criteria:

Living in a restricted environment that does not allow smoking (e.g., prison or jail facility, etc.)
Pregnant or nursing (all women of childbearing potential will be required to use an acceptable form of contraception)
Currently enrolled in a smoking cessation treatment program, using nicotine replacement products, or prescribed bupropion or varenicline
Known allergy nicotine lozenge
Within one month post-myocardial infarction or untreated severe angina
Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included)
Daily or exclusive use of other tobacco products (e.g., electronic cigarettes, little cigars, etc.).

Sites / Locations

University of Alabama, Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NicoBloc

Nicotine Lozenge

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Retention Rates

The total number of participants retained throughout the entirety of the study duration.

Full Information

NCT ID

NCT03720899

First Posted

October 17, 2018

Last Updated

March 30, 2022

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT03720899

Brief Title

Comparing NicoBloc to Nicotine Lozenges

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

March 21, 2019 (Actual)

Primary Completion Date

January 3, 2021 (Actual)

Study Completion Date

March 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation, Nicotine Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

participants will be randomized to one of two interventions

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NicoBloc

Arm Type

Experimental

Arm Description

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

Arm Title

Nicotine Lozenge

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

NicoBloc

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Nicotine Lozenge

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Treatment Satisfaction Survey

Description

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint

Description

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

Time Frame

Week 4

Title

Retention Rates

Description

The total number of participants retained throughout the entirety of the study duration.

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years or older planning to live in the Birmingham Metro area for the next 3 months 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 exclusive use of filtered cigarettes English speaking. Exclusion Criteria: Living in a restricted environment that does not allow smoking (e.g., prison or jail facility, etc.) Pregnant or nursing (all women of childbearing potential will be required to use an acceptable form of contraception) Currently enrolled in a smoking cessation treatment program, using nicotine replacement products, or prescribed bupropion or varenicline Known allergy nicotine lozenge Within one month post-myocardial infarction or untreated severe angina Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included) Daily or exclusive use of other tobacco products (e.g., electronic cigarettes, little cigars, etc.).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karen L Cropsey, Psy.D.

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama, Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

12. IPD Sharing Statement

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Comparing NicoBloc to Nicotine Lozenges

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