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Trial record 4 of 10 for:    CYTISINE

Cytisine Pharmacokinetics and Dose Response (C-DRAKS 3 and C-DRAKS 4)

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ClinicalTrials.gov Identifier: NCT02585024
Recruitment Status : Terminated
First Posted : October 23, 2015
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Natalie Walker, University of Auckland, New Zealand

Brief Summary:

A number of pharmacotherapies are available for smoking cessation in New Zealand including nicotine replacement therapy, bupropion, an antidepressant medication and varenicline. Of these, varenicline is the most effective, but also the most expensive. Varenicline acts like nicotine and stimulates nicotine receptors in the brain, but to a lesser extent, and simultaneously block nicotine binding to its receptors and thus reduces the rewarding effects of cigarette smoking. Cytisine (Tabex® and Desmoxan®) is a plant alkaloid and also acts in a similar way to varenicline but is significantly cheaper. It has been used for more than 50 years in some parts of eastern and central Europe as an aid to quit smoking, but is not approved for use in many countries such as New Zealand, Australia, the UK or the US. Randomised, placebo-controlled trials have shown that cytisine is more effective than placebo and nicotine replacement therapy (NRT)for smoking cessation. However there is a paucity of pre-clinical data on cytisine. In particular, there are limited data on the pharmacokinetic and the dose response characteristics of cytisine. Furthermore, the current dosing regimen recommended by the manufacturer is complex and has no clear basis in empirical research.

Complexity of dosing has been shown to be a key factor in determining adherence. Therefore, a simpler regimen would likely maximise the effectiveness of treatment through improved adherence to the treatment regimen. The investigators therefore propose to undertake two studies to investigate the influence of dose, dosing frequency and dosing duration on the pharmacokinetics and tolerability of cytisine and cigarette craving in smokers.


Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Cytisine Phase 1

Detailed Description:
see above

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cytisine as a Smoking Cessation Agent: Improving Adherence Through a Better Understanding of Pharmacokinetics and Dose Response
Study Start Date : February 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1.5 mg cytisine
1.5 mg cytisine given as a single dose
Drug: Cytisine
Other Name: Cytisine, Desmoxan

Experimental: 3 mg cytisine
3 mg cytisine given as a single dose
Drug: Cytisine
Other Name: Cytisine, Desmoxan

Experimental: 4.5 mg cytisine
4.5 mg cytisine given as a single dose
Drug: Cytisine
Other Name: Cytisine, Desmoxan

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
Drug: Cytisine
Other Name: Cytisine, Desmoxan

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
Drug: Cytisine
Other Name: Cytisine, Desmoxan

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
Drug: Cytisine
Other Name: Cytisine, Desmoxan




Primary Outcome Measures :
  1. Exposure (AUC) [ Time Frame: Arms 1-3: 24 hours; Arms 4-6: 24 hours, and up to Day 5 ]
    Plasma cytisine concentrations will be measured in all groups for 24 hours. For Arms 4-6, we will continue to take blood samples to measure cytisine concentrations throughout the dosing period (Days 1-5). Days 3-5: one blood sample will be taken before the first dose for the day. On Day 5 an extra blood sample will be taken at 7.5 hours post the first dose for that day.


Secondary Outcome Measures :
  1. Nicotine and cotinine concentrations [ Time Frame: Arms 1-3: 24 hours; Arms 4-6: 24 hours, and up to Day 5 ]
    Plasma nicotine and cotinine concentrations will be measured along with cytisine concentrations (from the same plasma samples)

  2. Craving for cigarettes [ Time Frame: 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 ]
    The brief Questionnaire on Smoking Urges will be administered

  3. Blood pressure [ Time Frame: 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 ]
    Systolic and diastolic blood pressure (mm Hg) will be measured with a blood pressure monitor

  4. Heart rate [ Time Frame: 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 ]
    Heart rate (beats per minute) will be simultaneously measured with blood pressure using a blood pressure monitor

  5. Respiratory rate [ Time Frame: 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 ]
    Respiratory rate (breaths per minute) will be measured along with blood pressure and heart rate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585024


Locations
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New Zealand
Soo Hee Jeong
Auckland, New Zealand, 1072
Sponsors and Collaborators
University of Auckland, New Zealand
Investigators
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Principal Investigator: Soo Hee Jeong, Phd University of Auckland, New Zealand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Natalie Walker, Associate Professor, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT02585024     History of Changes
Other Study ID Numbers: AMRF reference 1 1 15 011
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Natalie Walker, University of Auckland, New Zealand:
smoking
cytisine
Pharmacokinetics