Comparing NicoBloc to Nicotine Lozenges

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-21

Study Completion Date

2021-03-03

Brief Summary

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

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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.

Conditions

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Smoking Cessation Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

participants will be randomized to one of two interventions

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NicoBloc

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

Group Type EXPERIMENTAL

NicoBloc

Intervention Type DRUG

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 will use the lozenge in session and will discuss the effects of using the lozenge in session.

Group Type ACTIVE_COMPARATOR

Nicotine Lozenge

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No