Comparing NicoBloc to Nicotine Lozenges

NCT03720899 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 300001370
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation; Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• 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

  4 months

Secondary Outcomes (2)

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

  Week 4

• Retention Rates

  4 months

Study Arms (2)

NicoBloc

EXPERIMENTAL

NicoBloc participants will be provided with NicoBloc to use during counseling sessions and will test smoking their conventional cigarette with NicoBloc.

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.

Drug: Nicotine Lozenge

Interventions

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.

NicoBloc

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.

Nicotine Lozenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama, Birmingham

Birmingham, Alabama, 35209, United States

Location

Related Publications (1)

• 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.

  PMID: 37579108 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Karen Cropsey
• Organization: University of Alabama at Birmingham

kcropsey@uab.edu

(205) 975-7809

Study Officials

• Karen L Cropsey, Psy.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: participants will be randomized to one of two interventions

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 25, 2018
• Study Start: March 21, 2019
• Primary Completion: January 3, 2021
• Study Completion: March 3, 2021
• Last Updated: April 8, 2025
• Results First Posted: April 4, 2022

Record last verified: 2025-04

Locations

US (1)