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Trial registered on ANZCTR


Trial ID
ACTRN12617000590369
Ethics application status
Approved
Date submitted
20/04/2017
Date registered
27/04/2017
Date last updated
28/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preferences for Reduced Nicotine Cigarettes in Smokers
Scientific title
PRINCESS Study : Preferences for Reduced Nicotine Cigarettes in Smokers
Secondary ID [1] 291635 0
Nil Known
Universal Trial Number (UTN)
U1111-1195-1994
Trial acronym
PRINCESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking behaviour 302761 0
Condition category
Condition code
Mental Health 302276 302276 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Test products, dosages and route of administration

Very low nicotine cigarette MAGIC 0, crafted with carbon filter (Federal Trade Commission [FTC] nicotine yield per cigarette = 0.04mg, FTC tar yield per cigarette = 4.1 mg, 22nd Century Group, Inc).

This brand of VLNC (called MAGIC 0), manufactured by 22nd Century Group, Inc, has recently became available on the Europe market (although they are not available in New Zealand). Similar to the previously developed MAGIC, MAGIC 0 cigarettes yield only 0.04 mg nicotine per cigarette – 95% less nicotine than conventional cigarette brands. It has been claimed that the proprietary tobacco used in MAGIC 0 cigarettes has the taste of a conventional cigarette, but with lower-addictive levels of nicotine. According to the company, the addition of a carbon filter reduces toxic compounds in the smoke, and provides a full air flow smoking experience, making it different from previous products (e.g., MAGIC).

Each participant will be allocated to smoke one MAGIC 0 and one MAGIC cigarette at the study site. Participant will smoke each cigarette as closely as possible to their normal smoking pattern. After smoking each cigarette participants will be given a 45 minute washout period in order to complete the evaluation questionnaire and to allow most of the inhaled nicotine to be metabolised (nicotine has a half-life in plasma of nine minutes).

Reference therapy

Very low nicotine cigarette MAGIC (FTC nicotine yield per cigarette = 0.04mg, FTC tar yield per cigarette = 4.1 mg, 22nd Century Group, Inc).
Intervention code [1] 297762 0
Treatment: Other
Comparator / control treatment
Reference therapy
Very low nicotine cigarette MAGIC (FTC nicotine yield per cigarette = 0.04mg, FTC tar yield per cigarette = 4.1 mg, 22nd Century Group, Inc).
In contrast to MAGIC 0, MAGIC does not contain carbon filter.
Control group
Active

Outcomes
Primary outcome [1] 301735 0
Acceptability as measured using the satisfaction domain of the modified Cigarette Evaluation Questionnaire (mCEQ). This domain includes the three questions:

1) Was smoking satisfying?
2) Did the cigarettes taste good?
3) Did you enjoy smoking?

These questions will be self-rated by participants on a seven-point likert scale (1-not at all, 2 very little, 3-a little, 4-moderately, 5-a lot, 6-quite a lot, 7-extremely). An average of the three questions will be obtained to achieve a single overall measure of smoking satisfaction.
Timepoint [1] 301735 0
Immediately after finishing the single trial cigarette
Secondary outcome [1] 333701 0
Psychological Reward: measured by the mCEQ

1) Did smoking calm you down?
2) Did smoking make you feel more awake?
3) Did smoking make you feel less irritable?
4) Did smoking help you concentrate?
5) Did smoking reduce your hunger for food?
Timepoint [1] 333701 0
Secondary outcome measures will be measured immediately after smoking each cigarette
Secondary outcome [2] 333993 0
Craving reduction measured by the mCEQ

1) Did smoking immediately relieve your craving for a cigarette?

These questions will be self-rated by participants on a seven-point Likert scale (1-not at all, 2 very little, 3-a little, 4-moderately, 5-a lot, 6-quite a lot, 7-extremely).
Timepoint [2] 333993 0
Measured immediately after smoking each cigarette
Secondary outcome [3] 333994 0
Respiratory tract sensations from the mCEQ:

1) Did you enjoy the sensations in your throat and chest?

These questions will be self-rated by participants on a seven-point Likert scale (1-not at all, 2 very little, 3-a little, 4-moderately, 5-a lot, 6-quite a lot, 7-extremely).
Timepoint [3] 333994 0
Measured immediately after smoking each cigarette
Secondary outcome [4] 333995 0
Negative effects measured by the mCEQ

1) Did smoking make you dizzy?
2) Did smoking make you nauseous?

These questions will be self-rated by participants on a seven-point Likert scale (1-not at all, 2 very little, 3-a little, 4-moderately, 5-a lot, 6-quite a lot, 7-extremely).
Timepoint [4] 333995 0
Measured immediately after smoking each cigarette
Secondary outcome [5] 333996 0
Characteristics of the cigarette smoke

1) How strong did you find the cigarette smoke?
2) How hot did you find the cigarette smoke?
3) How hard was it to draw smoke from the cigarette?
4) How harsh did you find the cigarette smoke?
5) How intense did you find the flavour of the cigarette smoke?
6) How thick did you find the cigarette smoke?
7) How fresh did you find the cigarette smoke?
8) How heavy did you find the cigarette smoke?
9) How similar in taste did you find the cigarette compared to your usual brand?

All items will be self-rated by the participant on a seven-point scale from one (“not at all”) to seven (“extremely”).
Timepoint [5] 333996 0
Measured immediately after smoking each cigarette

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion in the study if they:

are daily smokers of non-menthol tobacco cigarettes
are willing and able to attend the study site for the entire duration of the study;
are at least 18 years of age;
have their first cigarette within 30 minutes of waking;
self-report being in good health;
are able to give written consent;
are able to read and write English.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants must not be currently using any form of smoking cessation therapy (e.g. NRT, buproprion [Zyban], clonidine, nortriptyline or vareniciline [Champix]) or be currently enrolled in a smoking cessation programme or cessation study. Pregnant women and women who are breastfeeding will be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Study power
A sample of 32 participants will be required to detect a difference in satisfaction scores between the treatments of at least 0.5 points on a 7-point scale, assuming the within-patient standard deviation of the response variable is 0.8. This estimate assumes 90% power that the study will detect a treatment difference at a two sided 5% significance level.
Statistical analysis
Baseline characteristics will be summarised. Comparison of the primary endpoint, (change in acceptability of different treatment conditions) will be compared by means of repeated measures analysis with a mixed model. Treatment by time interaction effects will be tested. Comparisons of ratings of acceptability and satisfaction will be made using mixed model analysis. P=0.05 as cut-off for significance; 95% Cis.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8791 0
New Zealand
State/province [1] 8791 0

Funding & Sponsors
Funding source category [1] 296129 0
Government body
Name [1] 296129 0
Health Research Council Tobacco Control Research Turanga
Address [1] 296129 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street (GPS: 50 Grafton Road), Grafton, Auckland 1010
Country [1] 296129 0
New Zealand
Primary sponsor type
University
Name
National Institute for Health Innovation, University of Auckland
Address
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 295151 0
None
Name [1] 295151 0
Address [1] 295151 0
Country [1] 295151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297382 0
University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 297382 0
Level 10, 49 Symonds Street, Auckland, 1010
Ethics committee country [1] 297382 0
New Zealand
Date submitted for ethics approval [1] 297382 0
07/03/2017
Approval date [1] 297382 0
03/04/2017
Ethics approval number [1] 297382 0
018902

Summary
Brief summary
Increasing attention has been given to the concept of very low nicotine content (VLNC) as a mean to help individuals quit smoking or reduce the harm from smoking. Although not safer than normal cigarettes, VLNC could dramatically improve public health by reducing the prevalence of smoking if they assist people to quit smoking. The viability of VLNC as a smoking cessation strategy hinges in part on their acceptability and the willingness of smokers to use them. Although our RELIQ trial found that users reduced their total number of cigarettes smoked, smoking satisfaction appeared low, with smokers disliking the taste of the VLNC. Since the publication of the RELIQ trial, a new type of VLNC cigarettes has become available, one with a charcoal filter that tobacco companies claim are far more acceptable to consumers than previous products, and therefore more likely to be used as part of an attempt to quit tobacco altogether. To assess the acceptability, psychological reward, craving reduction, and physical and sensory effects experienced when smoking a newly developed brand of Very Low Nicotine Cigarette (VLNC; MAGIC 0), in comparison to smoking a previously developed brand VLNC (MAGIC).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73866 0
A/Prof Natalie Walker
Address 73866 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 73866 0
New Zealand
Phone 73866 0
+64 9 373 7599 ext. 89884
Fax 73866 0
+64 9 373 1710
Email 73866 0
n.walker@auckland.ac.nz
Contact person for public queries
Name 73867 0
A/Prof Natalie Walker
Address 73867 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 73867 0
New Zealand
Phone 73867 0
+64 9 373 7599 ext. 89884
Fax 73867 0
Email 73867 0
n.walker@auckland.ac.nz
Contact person for scientific queries
Name 73868 0
A/Prof Natalie Walker
Address 73868 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 73868 0
New Zealand
Phone 73868 0
+64 9 373 7599 ext. 89884
Fax 73868 0
Email 73868 0
n.walker@auckland.ac.nz