ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000002785

Ethics application status

Approved

Date submitted

11/12/2012

Date registered

2/01/2013

Date last updated

6/02/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Cytisine as a smoking cessation aid: measuring blood levels, craving, withdrawal and mood over a course of treatment

Scientific title

Cytisine as a smoking cessation aid: measuring blood levels, craving, withdrawal and mood over a course of treatment

Secondary ID [1]

NIL

Universal Trial Number (UTN)

Trial acronym

C-DRAKS 2

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Smoking

Condition category

Condition code

Other

Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants are provided with a 25 day supply of cytisine tablets. Each tablet contains 1.5mg of cytisine:
Dosing schedule by the oral route:
Days 1-3: 1 tablet every 2 hours through the waking day (up to six tablets per day)
Days 4-12: 1 tablet every 2.5 hours (up to 5 per day); designated Quit date is day 5
Days 13-16: 1 tablet every 3 hours (up to 4 per day)
Days 17-20: 1 tablet every 4-5 hours (3 per day)
Days 21-25: 1 tablet every 6 hours (2 per day)

Participants are observed over the 25 days of cytisine intervention

Intervention code [1]

Not applicable

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Cytisine plasma levels measured by blood samples

Timepoint [1]

just before the first dose, then 2, 4, 6, 8, 10, 24 hours and then in the morning on days 2, 3, 4, 5, 6, 13, 14, 17, 18, 21, 22, 25 (plus again after 2, 4, and 6 hours), and day 26.

Secondary outcome [1]

Cotinine levels in saliva using Nicalert sticks.

Timepoint [1]

days 1,2,3,4,5,6,13,14,17,18,21,22,25

Secondary outcome [2]

vital signs - electronic blood pressure and pulse monitor

Timepoint [2]

just before the first dose, then 2, 4, 6, 8, 10, 24 hours and then in the morning on days 2, 3, 4, 5, 6, 13, 14, 17, 18, 21, 22, 25 (plus again after 2, 4, and 6 hours), and day 26.

Secondary outcome [3]

craving for cigarettes (Brief Questionnaire on Smoking Urges1)

Timepoint [3]

days 1,2,3,4,5,6,13,14,17,18,21,22,25, 26

Secondary outcome [4]

withdrawal (Mood and Physical Symptoms Score (MPSS), and the modified Cigarette Evaluation Questionnaire),

Timepoint [4]

days 1,2,3,4,5,6,13,14,17,18,21,22,25, 26

Secondary outcome [5]

mood (Profile of Mood States (POMS))

Timepoint [5]

days 1,2,3,4,5,6,13,14,17,18,21,22,25, 26

Secondary outcome [6]

metabolites in urine

Timepoint [6]

urine samples on days 1,2,3,4,5,6,13,14,17,18,21,22,25, 26

Eligibility

Key inclusion criteria

Smokers
They will be eligible for inclusion in the trial if:
- they are at least 18 years of age,
- they are able to provide written consent,
- willing to attempt to quit smoking
- are currently a regular smoker.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

-pregnant or breastfeeding,
-current users of NRT products,
-current users of non-NRT smoking cessation therapies (e.g. buproprion [registered tradename Zyban], clonidine, nortriptyline, or varenicline [registered tradename Champix]),
-enrolled in another smoking cessation programme
-have had a heart attack, stroke, or severe angina within the previous two weeks,
-have uncontrolled high blood pressure (> 150 mmHg systolic, > 100 mmHg diastolic),
-have phaeochromocytoma,
-suffer from schizophrenia.
-have severe renal impairment
-have had an adverse reaction to varenicline or cytisine

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

n/a

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 1

Type of endpoint/s

Pharmacokinetics / pharmacodynamics

Statistical methods / analysis

As this is an exploratory study, no formal statistical power was required.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/10/2012

Actual

16/11/2012

Date of last participant enrolment

Anticipated

Actual

25/01/2013

Date of last data collection

Anticipated

Actual

30/06/2014

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Auckland

Address [1]

Private Bag 92019
Auckland, 1142

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Auckland

Address

Private Bag 92019
Auckland, 1142

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disabilities Ethics Committee Northern X

Ethics committee address [1]

Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

30/06/2011

Ethics approval number [1]

NTX/11/05/038

Summary

Brief summary

Smoking is the most significant cause of lost healthy life in New Zealand. Smoking cessation dramatically reduces the risk of smoking–related diseases such as cardiovascular disease and cancer and is thus a key strategy for reducing health inequalities. Medicines currently available in New Zealand to help people stop smoking, such as nicotine replacement therapy (NRT), bupropion, nortriptyline and varenicline, are not used by many smokers (at least 70% of whom want to quit) because of low acceptability, side effects, cost and contraindications. Cytisine, an alkaloid found in plants such as Golden Rain and the New Zealand Kowhai, may address some of these concerns. Cytisine is a partial agonist at the nicotinic acetylcholine receptor (nAChR) and is thought to act by attenuating unpleasant tobacco withdrawal symptoms while simultaneously making smoking less rewarding. It has been used in Central and Eastern Europe for several decades.  Evidence from three placebo-controlled trials conducted several decades ago in Eastern Europe suggests that cytisine is effective. However, these trials reported limited safety data, and no other human data are available in the literature. With cytisine appearing promising as a smoking cessation aid, it is essential to obtain human pharmacokinetic, dose response and adverse effects data to inform future studies.

Trial website

Trial related presentations / publications

Jeong S., Tingle M., Sheridan J., Newcombe D. (2014). Cytisine Pharmacokinetics in Humans. Oral presentation at the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT)- NZ Annual Meeting, Queenstown, New Zealand. 

Jeong S., Tingle M., Sheridan J., Newcombe D. (2014). Cytisine - What happens to it in the body? Oral presentation at Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting Pre-conference Workshop titled Cytisine: A Globally Affordable Treatment for Tobacco Dependence? Seattle, USA. 

Jeong S., Newcombe D., Sheridan J., Tingle M. (2013). Cytisine as a smoking cessation aid: measuring craving, withdrawal and mood over a course of treatment. Oral presentation at the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT)- NZ Annual Meeting, Queenstown, New Zealand.

Public notes

Contacts

Principal investigator

Name

A/Prof Janie Sheridan

Address

School of Pharmacy
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6499235247

Fax

j.sheridan@auckland.ac.nz

Contact person for public queries

Name

Janie Sheridan

Address

School of Pharmacy
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6499235247

Fax

j.sheridan@auckland.ac.nz

Contact person for scientific queries

Name

Janie Sheridan

Address

School of Pharmacy
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6499235247

Fax

j.sheridan@auckland.ac.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Plasma concentrations of cytisine, a commercially available plant-based alkaloid, in healthy adult smokers taking recommended doses for smoking cessation.	2018	https://dx.doi.org/10.1080/00498254.2017.1409916

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically