Comparing NicoBloc to Nicotine Lozenges

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

Detailed Description
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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.

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

Conditions
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Smoking Cessation, Nicotine Dependence

Intervention / Treatment
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* Drug: NicoBloc
* Drug: Nicotine Lozenge


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants will be randomized to one of two interventions
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NicoBloc<br>NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc. | Drug: NicoBloc<br>* 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.<br>|
| Active Comparator: Nicotine Lozenge<br>Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session. | Drug: Nicotine Lozenge<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Retention Rates | The total number of participants retained throughout the entirety of the study duration. | 4 months |