Phase 3
N=45
Comparing NicoBloc to Nicotine Lozenges
Smoking Cessation · Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT03720899 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: The Treatment Satisfaction Survey — 63.62; 64.67 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NicoBloc (Drug); Nicotine Lozenge (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Treatment Satisfaction Survey |
63.62; 64.67 | — |
| SECONDARY Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint |
-1.75; -.65 | — |
| SECONDARY Retention Rates |
13; 13 | — |
Summary
To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges
Eligibility Criteria
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.).
Data sourced from ClinicalTrials.gov (NCT03720899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.