Comparing NicoBloc to Nicotine Lozenges

Last updated: April 4, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Completed

Phase

2/3

Condition

Stimulant Use Disorder

Smoking Cessation

Tobacco Use Disorder

Treatment

NicoBloc

Nicotine Lozenge

Clinical Study ID

NCT03720899
300001370
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years or older

  2. planning to live in the Birmingham Metro area for the next 3 months

  3. Smoking at least 5 cigarettes per day for the past year and a Carbon Monoxide>8ppmto ensure daily smoking. This relatively low cutoff was chosen due to theexpectation of enrolling a large >50% African-American average <10 cigarettes perday compared to Whites who average ~15 cigarettes per day

  4. exclusive use of filtered cigarettes

  5. English speaking.

Exclusion

Exclusion Criteria:

  1. Living in a restricted environment that does not allow smoking (e.g., prison or jailfacility, etc.)

  2. Pregnant or nursing (all women of childbearing potential will be required to use anacceptable form of contraception)

  3. Currently enrolled in a smoking cessation treatment program, using nicotinereplacement products, or prescribed bupropion or varenicline

  4. Known allergy nicotine lozenge

  5. Within one month post-myocardial infarction or untreated severe angina

  6. Cognitive impairment or unstable psychiatric condition that interferes with theinformed consent process (individuals stable on psychiatric medications will beincluded)

  7. Daily or exclusive use of other tobacco products (e.g., electronic cigarettes,little cigars, etc.).

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: NicoBloc
Phase: 2/3
Study Start date:
March 21, 2019
Estimated Completion Date:
March 03, 2021

Study 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.

Connect with a study center

  • University of Alabama, Birmingham

    Birmingham, Alabama 35209
    United States

    Site Not Available

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