A Phase 2/3 interventional study of NicoBloc and Nicotine Lozenge in Smoking Cessation and Nicotine Dependence, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by University of Alabama at Birmingham · Phase 2/3, Interventional, and Treatment
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 45 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc.
Drug: NicoBloc
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
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.
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 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
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
Retention Rates
The total number of participants retained throughout the entirety of the study duration.
Time frame: 4 months
| Milestone | NicoBloc | Nicotine Lozenge |
|---|---|---|
| Started | 21 | 24 |
| Completed | 13 | 13 |
| Not completed | 8 | 11 |
* 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
| score on a scale | NicoBloc | Nicotine Lozenge |
|---|---|---|
| The Treatment Satisfaction Survey | 63.62 ± 7.04 | 64.67 ± 17.25 |
* 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
| Pre - Post Mean Score | NicoBloc | Nicotine Lozenge |
|---|---|---|
| Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint | -1.75 ± 5.6 | -.65 ± 5.06 |
The total number of participants retained throughout the entirety of the study duration.
| Participants | NicoBloc | Nicotine Lozenge |
|---|---|---|
| Retention Rates | 13 | 13 |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NicoBloc | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Nicotine Lozenge | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Categorical(Participants) | NicoBloc | Nicotine Lozenge | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 22 | 40 |
| >=65 years | 3 | 2 | 5 |
| Sex: Female, Male(Participants) | NicoBloc | Nicotine Lozenge | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 15 | 17 | 32 |
| Race (NIH/OMB)(Participants) | NicoBloc | Nicotine Lozenge | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 17 | 30 |
| White | 8 | 5 | 13 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | NicoBloc | Nicotine Lozenge | Total |
|---|---|---|---|
| United States | 21 | 24 | 45 |
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University of Alabama at Birmingham