Nicotine Dependence, Smoking Cessation
Conditions
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.
Interventions
DRUGNicoBloc
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.
DRUGNicotine 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
participants will be randomized to one of two interventions
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NicoBloc NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc.
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. | 21 |
| Nicotine Lozenge Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session.
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. | 24 |
| Total | 45 |
Baseline characteristics
| Characteristic | NicoBloc | Nicotine Lozenge | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 22 Participants | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 17 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 5 Participants | 13 Participants |
| Region of Enrollment United States | 21 participants | 24 participants | 45 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 15 Participants | 17 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 24 |
| other Total, other adverse events | 0 / 21 | 0 / 24 |
| serious Total, serious adverse events | 0 / 21 | 0 / 24 |
Outcome results
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
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NicoBloc | The Treatment Satisfaction Survey | 63.62 score on a scale | Standard Deviation 7.04 |
| Nicotine Lozenge | The Treatment Satisfaction Survey | 64.67 score on a scale | Standard Deviation 17.25 |
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
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NicoBloc | Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint | -1.75 Pre - Post Mean Score | Standard Deviation 5.6 |
| Nicotine Lozenge | Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint | -.65 Pre - Post Mean Score | Standard Deviation 5.06 |
Secondary
Retention Rates
The total number of participants retained throughout the entirety of the study duration.
Time frame: 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NicoBloc | Retention Rates | 13 Participants |
| Nicotine Lozenge | Retention Rates | 13 Participants |