NCT03720899

Comparing NicoBloc to Nicotine Lozenges

Completed Phase 2, PHASE3 Results posted Last updated 8 April 2025

What this trial tests

Phase 2, PHASE3 trial testing NicoBloc in Smoking Cessation in 45 participants. Completed in 3 March 2021.

Timeline

21 March 2019

Primary endpoint
3 January 2021

3 March 2021

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	21 March 2019
Primary completion	3 January 2021
Estimated completion	3 March 2021
Sites	1 location across United States

Drugs / interventions tested

• NicoBloc — full drug profile →
• Nicotine Lozenge — full drug profile →

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →
• Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, any sex, with Smoking Cessation or Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Treatment Satisfaction Survey Primary · 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

Group	Value	95% CI
NicoBloc	63.62	± 7.04
Nicotine Lozenge	64.67	± 17.25

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

Group	Value	95% CI
NicoBloc	-1.75	± 5.6
Nicotine Lozenge	-.65	± 5.06

Retention Rates Secondary · 4 months

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

Group	Value	95% CI
NicoBloc	13
Nicotine Lozenge	13

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An Open-label Pilot Study of NicoBloc as a Novel Smoking Cessation Intervention.
   Chichester KR, Sisson ML, Chana SM, Wolford-Clevenger C, et al · · 2023 · PMID 37579108 · DOI 10.1097/adm.0000000000001157