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To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NicoBloc | Experimental | NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc. |
|
| Nicotine Lozenge | Active Comparator | Participants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NicoBloc | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Treatment Satisfaction Survey |
| 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint |
| Week 4 |
| Retention Rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen L Cropsey, Psy.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37579108 | Derived | Chichester KR, Sisson ML, Chana SM, Wolford-Clevenger C, Hugley MJ, Hawes ES, Palenski P, Nguyen A, Dahne J, Hendricks PS, Cropsey KL. An Open-label Pilot Study of NicoBloc as a Novel Smoking Cessation Intervention. J Addict Med. 2023 Jul-Aug 01;17(4):e269-e277. doi: 10.1097/ADM.0000000000001157. Epub 2023 Mar 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Treatment Satisfaction Survey |
| Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Cropsey | University of Alabama at Birmingham | (205) 975-7809 | kcropsey@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2019 | Mar 2, 2022 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2022 | Mar 2, 2022 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 1, 2019 | Mar 2, 2022 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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participants will be randomized to one of two interventions
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|
| Nicotine Lozenge | 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. |
|
The total number of participants retained throughout the entirety of the study duration. |
| 4 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint |
| Posted | Mean | Standard Deviation | Pre - Post Mean Score | Week 4 |
|
|
|
| Secondary | Retention Rates | The total number of participants retained throughout the entirety of the study duration. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D001523 |
| Mental Disorders |