Smoking CessationPhase 2/3NCT03720899
Comparing NicoBloc to Nicotine Lozenges
A Phase 2/3 study testing NicoBloc and Nicotine Lozenge in people with Smoking Cessation and Nicotine Dependence, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Nicotine Dependence
- What is being tested?
- NicoBloc and Nicotine Lozenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 3 Mar 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama, Birmingham
Birmingham, Alabama, 35209
About this study
Official title: A Pilot Trial Comparing NicoBloc to Nicotine Lozenges: Initial Acceptability and Feasibility Trial
To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges
Read the 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.
- Conditions
- Smoking Cessation, Nicotine Dependence
- Being tested
- NicoBloc, Nicotine Lozenge
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicoBlocDrug
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 LozengeDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NicoBloc | Experimental | NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc. Receives: Drug: 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. Receives: Drug: Nicotine Lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (2)
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
Measured: Week 4
Retention Rates
The total number of participants retained throughout the entirety of the study duration.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start21 Mar 2019
- Primary completion3 Jan 2021
- Study completion3 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants will be randomized to one of two interventions
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Cropsey, University of Alabama at Birmingham
- Investigators
- Karen L Cropsey, Psy.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720899
- Sponsor's protocol ID
- 300001370
- Status last verified
- Apr 2025
- First submitted
- 17 Oct 2018
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37579108
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial Comparing NicoBloc to Nicotine Lozenges: Initial Acceptability and Feasibility Trial
- ClinicalTrials.gov ID
- NCT03720899
- Acronym / sponsor ID
- 300001370
- Conditions
- Smoking Cessation, Nicotine Dependence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 3 Jan 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Posted 4 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- participants will be randomized to one of two interventions
| Arm | Type | Receives |
|---|---|---|
| NicoBloc | Experimental | Drug: NicoBlocNicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc. |
| Nicotine Lozenge | Active comparator | Drug: Nicotine LozengeParticipants who receive nicotine lozenge will use the lozenge in session and will discuss the effects of using the lozenge in session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NicoBlocFor 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. | Drug | NicoBloc |
| Nicotine LozengeParticipants 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. | Drug | Nicotine Lozenge |
Primary outcome
The Treatment Satisfaction Survey
Time frame: 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
2 secondary outcomes
Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint
Time frame: Week 4
Retention Rates
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37579108Chichester 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L Cropsey, Psy.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NicoBloc and Nicotine Lozenge in people with Smoking Cessation and Nicotine Dependence, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Treatment Satisfaction Survey (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03720899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.