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CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products

NCT04167384 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-03-12

No results posted yet for this study

Summary

This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the study investigational products (IPs) by generally healthy subjects.

Conditions

  • Smoking
  • Tobacco Use
  • Tobacco Smoking

Interventions

OTHER

Product A

Usual brand (UB) filtered, combustible cigarette

OTHER

Product B

Nicorette® Mint 4 mg nicotine lozenge

OTHER

Product C

CSD1903-11, a hard nicotine lozenge, 2 mg nicotine

OTHER

Product D

CSD1903-11, a hard nicotine lozenge, 4 mg nicotine

OTHER

Product E

CSD1903-11, a hard nicotine lozenge, 8 mg nicotine

OTHER

Product F

CSD1903-12, a soft nicotine lozenge, 2 mg nicotine

OTHER

Product G

CSD1903-12, a soft nicotine lozenge, 4 mg nicotine

OTHER

Product H

CSD1903-12, a soft nicotine lozenge, 8 mg nicotine

Sponsors & Collaborators

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Christine Campbell · RAIS

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2020-02-28
Completion
2020-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04167384 on ClinicalTrials.gov