A Single Dose-escalation Study of Cytisine in Adult Smokers

A Phase 1 study testing cytisine in people with Smoking Cessation, run by Achieve Life Sciences at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objectives of this study are: 1. To assess the tolerability and safety of cytisine as a single oral dose. 2. To define the Cmax levels associated to the occurrence of dose-limiting adverse events. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Smoking Cessation
What is being tested?: cytisine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 1 sitePortugal
Study dates: 28 Feb 2019to 12 Sep 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must meet ALL of the following criteria to be eligible for inclusion into the study:
Free written informed consent prior to any procedure required by the study.
Male or female subjects, age ≥18 years, at the time of signing the informed consent.
Current daily cigarette smokers (averaging at least 10 cigarettes per day in the past 30 days).
Expired air carbon monoxide (CO) ≥10 ppm.
Able to swallow multiple tablets at one time.
Able to fully understand, comply with all study requirements.

Who cannot join

Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study at screening.
Known hypersensitivity to cytisine or any of the excipients.
Known severe hypersensitivity to any other drug.
Positive urinary drugs of abuse screen, determined within 28 days before cytisine/placebo dosing.
Positive ethanol breath test.
Clinically significant abnormal serum chemistry, hematology, coagulation or urinalysis values within 28 days of randomization (i.e. requiring treatment or monitoring).

Show all 27Show fewer

Clinically significant abnormalities in 12-lead echocardiogram (ECG) determined after minimum of 5 minutes in supine position within 28 days of randomization (i.e. requiring treatment or further assessment).
Body Mass Index (BMI) classification for being underweight (<18.5 kg/m2) or having ≥Class 2 obesity (≥35 kg/m2).
History of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident, cardiac arrhythmia, or hospitalization for congestive heart failure.
Blood pressure ≥160/100 mmHg, measured on the dominant arm, after at least 3 minutes in supine position.
Creatinine clearance (CrCl) <80 mL/min (estimated with the Cockroft-Gault equation).
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x the upper limit of normal (ULN).
Any inability to comply with study restrictions (See Section 9)
Any inability or difficulty in fasting.
Difficulty in donating blood on either arm.
If woman of childbearing potential, positive result in serum beta-human chorionic gonadotropin (hCG) pregnancy test.
Women who are breast-feeding.
Subjects who do not agree to use acceptable methods of birth control during the study (See Section 9.4).
Participation in a clinical study with an investigational drug within the previous 2 months.
Participation in more than 2 clinical trials within the previous 12 months.
Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study at admission to each cohort.
Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation.
Positive urinary drugs of abuse screen.
Positive ethanol breath test.
If female of childbearing potential, positive result in urine beta-hCG pregnancy test.
Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

BlueClinical
Porto, 4250-449

Other trials in Portugal

About this study

Official title: A Phase I, Double-blind, Randomized, Placebo-controlled, Single Dose-escalation Study to Evaluate the Tolerability and Safety of Cytisine in Adult Smokers

The objectives of this study are:

To assess the tolerability and safety of cytisine as a single oral dose.
To define the Cmax levels associated to the occurrence of dose-limiting adverse events.

Conditions: Smoking Cessation
Being tested: cytisine, placebo
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

cytisineDrug
Also called Tabex, cytisinicline
cytisine film-coated oral tablet
placeboDrug
matching placebo oral tablet

Study groups in NCT03848208
Study group	Role	What they receive
Cohort 1: Cytisine 6.0 mg	Experimental	Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: cytisine
Cohort 1: Placebo	Placebo comparator	Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: placebo
Cohort 2: Cytisine 9.0 mg	Experimental	Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: cytisine
Cohort 2: Placebo	Placebo comparator	Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: placebo
Cohort 3: Cytisine 12.0 mg	Experimental	Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: cytisine
Cohort 3: Placebo	Placebo comparator	Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: placebo
Cohort 4: Cytisine 15.0 mg	Experimental	Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: cytisine
Cohort 4: Placebo	Placebo comparator	Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: placebo
Cohort 5: Cytisine 18.0 mg	Experimental	Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: cytisine
Cohort 5: Placebo	Placebo comparator	Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: placebo
Cohort 6: Cytisine 21.0 mg	Experimental	Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: cytisine
Cohort 6: Placebo	Placebo comparator	Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: placebo
Cohort 7: Cytisine 24.0 mg	Experimental	Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: cytisine
Cohort 7: Placebo	Placebo comparator	Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: placebo
Cohort 8: Cytisine 27.0 mg	Experimental	Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: cytisine
Cohort 8: Placebo	Placebo comparator	Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: placebo
Cohort 9: Cytisine 30.0 mg	Experimental	Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: cytisine
Cohort 9: Placebo	Placebo comparator	Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours. Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Study Discontinuation
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have to have a causal relationship with the treatment. A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event which requires medical intervention to prevent one of the above. Treatment emergent events are those that occurred after the first dose of study drug.
Measured: From first dose of study drug through Day 6
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1: Pre-dose (within 30 minutes prior to dosing), 15, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours (+/-2 minutes) post-dose
Pharmacokinetics: Time to Occurrence of Cmax (Tmax)
Measured: Day 1: Pre-dose (within 30 minutes prior to dosing), 15, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours (+/-2 minutes) post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 201912 Sep 2019

First posted20 Feb 2019
Study start28 Feb 2019
Primary completion12 Sep 2019
Study completion12 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Smoking CessationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03848208
Sponsor's protocol ID: ACH-CYT-08
Other IDs: 2018-003344-22, 2018
Status last verified: Aug 2020
First submitted: 19 Feb 2019
Last updated: 17 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Double-blind, Randomized, Placebo-controlled, Single Dose-escalation Study to Evaluate the Tolerability and Safety of Cytisine in Adult Smokers
ClinicalTrials.gov ID: NCT03848208
Acronym / sponsor ID: ACH-CYT-08
Conditions: Smoking Cessation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Achieve Life SciencesIndustry (pharma, biotech, devices)
Study start: 28 Feb 2019 (actual)
Primary completion: 12 Sep 2019 (actual)
Study completion: 12 Sep 2019 (actual)
First posted: 20 Feb 2019 (actual)
Results: Posted 17 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objectives of this study are:

To assess the tolerability and safety of cytisine as a single oral dose.
To define the Cmax levels associated to the occurrence of dose-limiting adverse events.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 18

Arm	Type	Receives
Cohort 1: Cytisine 6.0 mg	Experimental	Drug: cytisineCytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 1: Placebo	Placebo comparator	Drug: placeboPlacebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 2: Cytisine 9.0 mg	Experimental	Drug: cytisineCytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 2: Placebo	Placebo comparator	Drug: placeboPlacebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 3: Cytisine 12.0 mg	Experimental	Drug: cytisineCytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 3: Placebo	Placebo comparator	Drug: placeboPlacebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 4: Cytisine 15.0 mg	Experimental	Drug: cytisineCytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 4: Placebo	Placebo comparator	Drug: placeboPlacebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 5: Cytisine 18.0 mg	Experimental	Drug: cytisineCytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 5: Placebo	Placebo comparator	Drug: placeboPlacebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 6: Cytisine 21.0 mg	Experimental	Drug: cytisineCytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 6: Placebo	Placebo comparator	Drug: placeboPlacebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 7: Cytisine 24.0 mg	Experimental	Drug: cytisineCytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 7: Placebo	Placebo comparator	Drug: placeboPlacebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 8: Cytisine 27.0 mg	Experimental	Drug: cytisineCytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 8: Placebo	Placebo comparator	Drug: placeboPlacebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 9: Cytisine 30.0 mg	Experimental	Drug: cytisineCytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
Cohort 9: Placebo	Placebo comparator	Drug: placeboPlacebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subjects must meet ALL of the following criteria to be eligible for inclusion into the study:
Free written informed consent prior to any procedure required by the study.
Male or female subjects, age ≥18 years, at the time of signing the informed consent.
Current daily cigarette smokers (averaging at least 10 cigarettes per day in the past 30 days).
Expired air carbon monoxide (CO) ≥10 ppm.

Key exclusion criteria (27 listed)

Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study at screening.
Known hypersensitivity to cytisine or any of the excipients.
Known severe hypersensitivity to any other drug.
Positive urinary drugs of abuse screen, determined within 28 days before cytisine/placebo dosing.
Positive ethanol breath test.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
cytisineAlso: Tabex, cytisiniclinecytisine film-coated oral tablet	Drug	Cohort 1: Cytisine 6.0 mg, Cohort 2: Cytisine 9.0 mg, Cohort 3: Cytisine 12.0 mg, Cohort 4: Cytisine 15.0 mg, Cohort 5: Cytisine 18.0 mg, Cohort 6: Cytisine 21.0 mg, Cohort 7: Cytisine 24.0 mg, Cohort 8: Cytisine 27.0 mg, Cohort 9: Cytisine 30.0 mg
placebomatching placebo oral tablet	Drug	Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo, Cohort 4: Placebo, Cohort 5: Placebo, Cohort 6: Placebo, Cohort 7: Placebo, Cohort 8: Placebo, Cohort 9: Placebo

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Study Discontinuation
Time frame: From first dose of study drug through Day 6
An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have to have a causal relationship with the treatment. A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event which requires medical intervention to prevent one of the above. Treatment emergent events are those that occurred after the first dose of study drug.
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1: Pre-dose (within 30 minutes prior to dosing), 15, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours (+/-2 minutes) post-dose
Pharmacokinetics: Time to Occurrence of Cmax (Tmax)
Time frame: Day 1: Pre-dose (within 30 minutes prior to dosing), 15, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours (+/-2 minutes) post-dose

Results and safety

Results posted to the registry on 17 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	18	18
Cytisine 6 mg	6	6
Cytisine 9 mg	6	6
Cytisine 12 mg	6	6
Cytisine 15 mg	6	6
Cytisine 18 mg	6	6
Cytisine 21 mg	6	6
Cytisine 24 mg	6	6
Cytisine 27 mg	6	6
Cytisine 30 mg	6	6

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Study Discontinuation

Time frame: From first dose of study drug through Day 6. Number. Unit: participants

Measure	Placebo n = 18	Cytisine 6 mg n = 6	Cytisine 9 mg n = 6	Cytisine 12 mg n = 6	Cytisine 15 mg n = 6	Cytisine 18 mg n = 6	Cytisine 21 mg n = 6	Cytisine 24 mg n = 6	Cytisine 27 mg n = 6	Cytisine 30 mg n = 6
Any TEAE	5	2	1	4	3	2	1	2	2	4
Serious TEAE	0	0	0	0	0	0	0	0	0	0
TEAE Leading to Study Discontinuation	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety Set: all participants who received study drug.

Primary outcome: Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 1: Pre-dose (within 30 minutes prior to dosing), 15, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours (+/-2 minutes) post-dose. Mean (90% Confidence Interval). Unit: ng/mL

Measure	Cytisine 6 mg n = 6	Cytisine 9 mg n = 6	Cytisine 12 mg n = 6	Cytisine 15 mg n = 6	Cytisine 18 mg n = 6	Cytisine 21 mg n = 6	Cytisine 24 mg n = 6	Cytisine 27 mg n = 6	Cytisine 30 mg n = 6
Value	71.05 (56.07 to 86.03)	93.62 (79.44 to 107.79)	94.27 (74.87 to 113.66)	126.45 (100.82 to 152.07)	134.94 (107.00 to 162.88)	150.08 (114.12 to 186.04)	171.44 (149.31 to 193.57)	151.05 (122.01 to 180.08)	166.65 (120.95 to 212.34)

Population analysed: Pharmacokinetic Analysis Set: all participants who received a dose of cytisine and had evaluable pharmacokinetic data.

Primary outcome: Pharmacokinetics: Time to Occurrence of Cmax (Tmax)

Time frame: Day 1: Pre-dose (within 30 minutes prior to dosing), 15, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours (+/-2 minutes) post-dose. Median (Full Range). Unit: hours

Measure	Cytisine 6 mg n = 6	Cytisine 9 mg n = 6	Cytisine 12 mg n = 6	Cytisine 15 mg n = 6	Cytisine 18 mg n = 6	Cytisine 21 mg n = 6	Cytisine 24 mg n = 6	Cytisine 27 mg n = 6	Cytisine 30 mg n = 6
Value	0.83 (0.50 to 2.00)	1.38 (0.83 to 2.50)	1.88 (1.25 to 2.50)	1.88 (0.50 to 2.50)	2.00 (1.50 to 3.00)	1.89 (1.25 to 3.00)	2.50 (0.83 to 3.00)	2.75 (1.75 to 3.00)	2.50 (1.00 to 3.00)

Population analysed: Pharmacokinetic Analysis Set: all participants who received a dose of cytisine and had evaluable pharmacokinetic data.

Adverse events

Time frame: From first dose of study drug through Day 6. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 18 (0%)	5 of 18 (27.8%)	0 of 18
Cytisine 6 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cytisine 9 mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Cytisine 12 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Cytisine 15 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cytisine 18 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cytisine 21 mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Cytisine 24 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cytisine 27 mg	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Cytisine 30 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Smoking Cessation

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marlene Fonseca, MD principal investigator

Hospital da Prelada

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cytisine in people with Smoking Cessation, run by Achieve Life Sciences at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Study Discontinuation (time frame: From first dose of study drug through Day 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03848208.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.