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OpenTrials
Completed

NCT Number: NCT03720899

Comparing NicoBloc to Nicotine Lozenges

To examine the feasibility, acceptability, and preliminary impact of using NicoBloc compared to nicotine lozenges

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alabama, Birmingham

Birmingham, Alabama, 35209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in the Questionnaire of Smoking Urges-Brief Form, From Baseline to Week 4 Timepoint

    Time frame: 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
  2. Retention Rates

    Time frame: 4 months

    The total number of participants retained throughout the entirety of the study duration.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

A Pilot Trial Comparing NicoBloc to Nicotine Lozenges: Initial Acceptability and Feasibility Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 25, 2018
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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