NCT04891406

Brief Summary

This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a cross-over fashion. The study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation. During the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 13, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

May 12, 2021

Results QC Date

July 6, 2022

Last Update Submit

October 12, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Nicotine Cmax

    Maximum plasma concentration of nicotine (Cmax)

    Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start

  • Nicotine AUCt

    Area under the plasma nicotine concentration-time curve at the last timepoint measured (AUCt)

    Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start

Secondary Outcomes (1)

  • Nicotine Extraction

    20 minutes

Study Arms (5)

ABCDE

OTHER

Subjects use product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes on Day 1, then switch to use product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 min on Day 2, then product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 min on Day 3, then D (nicotine pouch, 10.6 mg/pouch) on Day 4 and finally E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette), smoked in approximately 5 minutes with puffs taken at regular intervals approximately 30 seconds apart, on Day 5. Subjects can use their assigned product ad libitum on each study day, after all study assessments are performed, until 10pm. A washout period of product abstinence is observed between products, overnight.

Other: AOther: BOther: COther: DOther: E

BCDEA

OTHER

Same as previous arm but in a different randomization order.

Other: AOther: BOther: COther: DOther: E

CDEAB

OTHER

Same as previous arm but in a different randomization order.

Other: AOther: BOther: COther: DOther: E

DEABC

OTHER

Same as previous arm but in a different randomization order.

Other: AOther: BOther: COther: DOther: E

EABCD

OTHER

Same as previous arm but in a different randomization order.

Other: AOther: BOther: COther: DOther: E

Interventions

AOTHER

Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes

Also known as: Product A
ABCDEBCDEACDEABDEABCEABCD
BOTHER

Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes

Also known as: Product B
ABCDEBCDEACDEABDEABCEABCD
COTHER

Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes

Also known as: Product C
ABCDEBCDEACDEABDEABCEABCD
DOTHER

Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes

Also known as: Product D
ABCDEBCDEACDEABDEABCEABCD
EOTHER

Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes

Also known as: Product E
ABCDEBCDEACDEABDEABCEABCD

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m
  • Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator
  • Dual user of snus and conventional cigarettes for ≥1 year, with a minimum weekly consumption of two or more snus cans and \>5 cigarettes, and who is willing and able to use brands with nicotine content ≥1%

You may not qualify if:

  • History of any clinically significant disease or disorder
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of IP
  • Positive for HIV, hepatitis B or C
  • After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
  • Systolic blood pressure \<90 or \>140 mmHg, or
  • Diastolic blood pressure \<50 or \>90 mmHg, or
  • Pulse \<40 or \>90 bpm
  • Alcohol or drug abuse
  • Use, or history of use of anabolic steroids
  • Allergy/hypersensitivity to drugs with a similar chemical structure or class to nicotine
  • Excessive caffeine consumption (daily intake of \>5 cups)
  • Female subjects who are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CTC Clinical Trial Consultants AB (CTC)

Uppsala, SE-752 37, Sweden

Location

Related Publications (1)

  • Chapman F, McDermott S, Rudd K, Taverner V, Stevenson M, Chaudhary N, Reichmann K, Thompson J, Nahde T, O'Connell G. A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic, pharmacodynamic and safety and tolerability profiles of tobacco-free oral nicotine pouches relative to cigarettes. Psychopharmacology (Berl). 2022 Sep;239(9):2931-2943. doi: 10.1007/s00213-022-06178-6. Epub 2022 Jun 23.

    PMID: 35732751DERIVED

MeSH Terms

Interventions

Fumigant 93HTR3D protein, human

Results Point of Contact

Title
Simon McDermott
Organization
Imperial Tobacco Ltd
simon.mcdermott@uk.imptob.co
+44 (0)117 332 0225

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 18, 2021

Study Start

July 1, 2020

Primary Completion

January 20, 2021

Study Completion

January 20, 2021

Last Updated

October 13, 2023

Results First Posted

October 13, 2023

Record last verified: 2023-10

Locations

SE(1)