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

Phase 1

Completed

• Conditions: Smoking; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12613000002785
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cytisine plasma levels measured by blood samples [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 Measures

Name	Time	Method
Cotinine levels in saliva using Nicalert sticks.[days 1,2,3,4,5,6,13,14,17,18,21,22,25 ];vital signs - electronic blood pressure and pulse monitor[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. ];craving for cigarettes (Brief Questionnaire on Smoking Urges1)[days 1,2,3,4,5,6,13,14,17,18,21,22,25, 26 ];withdrawal (Mood and Physical Symptoms Score (MPSS), and the modified Cigarette Evaluation Questionnaire),[days 1,2,3,4,5,6,13,14,17,18,21,22,25, 26];mood (Profile of Mood States (POMS))[days 1,2,3,4,5,6,13,14,17,18,21,22,25, 26];metabolites in urine[urine samples on days 1,2,3,4,5,6,13,14,17,18,21,22,25, 26]