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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02585024




Registration number
NCT02585024
Ethics application status
Date submitted
21/10/2015
Date registered
23/10/2015

Titles & IDs
Public title
Cytisine Pharmacokinetics and Dose Response (C-DRAKS 3 and C-DRAKS 4)
Scientific title
Cytisine as a Smoking Cessation Agent: Improving Adherence Through a Better Understanding of Pharmacokinetics and Dose Response
Secondary ID [1] 0 0
AMRF reference 1 1 15 011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: 1.5 mg cytisine - 1.5 mg cytisine given as a single dose

Experimental: 3 mg cytisine - 3 mg cytisine given as a single dose

Experimental: 4.5 mg cytisine - 4.5 mg cytisine given as a single dose

Experimental: 1.5 mg cytisine six times a day - 1.5 mg (1 capsule) is given six times a day (0, 2, 4, 6, 8 and 10 hours) for 5 days

Experimental: 3 mg cytisine three times a day - 3 mg (2 capsules) are given three times a day (0, 4 and 8 hours) for 5 days

Experimental: 4.5 mg cytisine two times a day - 4.5 mg (3 capsules) are given two times a day (0 and 6 hours) for 5 days
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Exposure (AUC)
Timepoint [1] 0 0
Arms 1-3: 24 hours; Arms 4-6: 24 hours, and up to Day 5
Secondary outcome [1] 0 0
Nicotine and cotinine concentrations
Timepoint [1] 0 0
Arms 1-3: 24 hours; Arms 4-6: 24 hours, and up to Day 5
Secondary outcome [2] 0 0
Craving for cigarettes
Timepoint [2] 0 0
Arms 1-3: 0, 1, 2, 4, 6, 8, 10 and 24 hours. Arms 4-6: 0, 2, 4 ,6, 8, 10, 24 hours; once on Days 3- 5
Secondary outcome [3] 0 0
Blood pressure
Timepoint [3] 0 0
Arms: 1-3: 0, 1, 2, 4, 6, 8, 10, 24 hours. Arms 4-6: 0, 2, 4, 6, 8, 10, 24 hours; once on Days 3- 5
Secondary outcome [4] 0 0
Heart rate
Timepoint [4] 0 0
Arms: 1-3: 0, 1, 2, 4, 6, 8, 10, 24 hours. Arms 4-6: 0, 2, 4, 6, 8, 10, 24 hours; once on Days 3- 5
Secondary outcome [5] 0 0
Respiratory rate
Timepoint [5] 0 0
Arms: 1-3: 0, 1, 2, 4, 6, 8, 10, 24 hours. Arms 4-6: 0, 2, 4, 6, 8, 10, 24 hours; once on Days 3- 5

Eligibility
Key inclusion criteria
* be at least 18 years of age,
* be able to provide written consent,
* have no significant medical or psychiatric disorder (see below under exclusion criteria)
* smoke at least 10 cigarettes a day
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* they are pregnant or breastfeeding,
* they are current users of NRT products,
* they are current users of non-NRT smoking cessation therapies (e.g. bupropion [Zyban®], clonidine, nortriptyline, or varenicline [Champix®]),
* they are enrolled in another smoking cessation programme (concurrent referral to a face-to-face provider from Quitline is acceptable) or other cessation study
* they have had a heart attack, stroke, or severe angina within the past three months,
* they have uncontrolled high blood pressure (> 150 mmHg systolic, > 100 mmHg diastolic),
* they have phaeochromocytoma,
* they have been diagnosed with epilepsy
* they suffer from significant mental health problems
* they have severe renal impairment
* they are taking medications which are significantly affected by cessation of smoking (e.g. warfarin, olanzapine, clozapine, therophylline, etc.)

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2019
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Soo Hee Jeong, Phd
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02585024