Nicotine AddictionPhase 4NCT04126135
Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy
A Phase 4 study testing Cytisine and Nicotine Replacement Therapy (NRT) in people with Nicotine Addiction, run by Loma Linda University at 1 site in Mongolia.
Trial summary
A pragmatic, single blinded, randomized, controlled non-inferiority trial of Cytisine versus Nicotine Replacement Therapy for continuous abstinence is conducted in the government run primary health hospitals in Mongolia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Nicotine Addiction
- What is being tested?
- Cytisine and Nicotine Replacement Therapy (NRT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,307 participants
- Where
- 1 siteMongolia
- Study dates
- 27 Jan 2022to 20 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seeking smoking cessation treatment
- Ages 18 years or older
- Currently smoking > 5 cigarettes per day
- Willingness to make quit attempt with pharmacotherapy
- Able to provide verbal and written informed consent
- Have telephone access
Who cannot join
- Pregnancy or currently breastfeeding
- Current users of NRT (patch, gum, lozenge)
- Current users of non_NRT smoking cessation pharmacotherapy
- Enrolled in another smoking cessation program (non-governmental)
- Clinical disorder that contraindicates use of NRT or Cytisine (heart attack, stroke, severe angina within the past 2 weeks, uncontrolled hypertension, phaeochromocytoma, severe mental illness)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy (NRT) in the National Smoking Cessation Program of Mongolia: A Pragmatic Non-Inferiority Trial
A pragmatic, single blinded, randomized, controlled non-inferiority trial of Cytisine versus Nicotine Replacement Therapy for continuous abstinence is conducted in the government run primary health hospitals in Mongolia.
Read the detailed description
Rationale: In Mongolia, smoking cessation assistance in the governmental health sector consists of behavioral counseling and a 3-week regimen of the NRT patch that costs 175 USD. This cost for low income adults limits effectiveness. A 2014 study documented the superiority and lower cost (<20 USD) of Cytisine versus NRT for continuous abstinence. Trial investigators are testing the comparative effectiveness of Cytisine in the "real life setting" of their national health care system and, if proven effective, will include coverage for Cytisine in the national health plan.
Research Question/Objective: To determine whether a 25 day course of Cytisine tablets is at least as effective as 25 days of NRT in helping smokers remain abstinent for at least one month.
Design: A pragmatic, single blinded, randomized, controlled non-inferiority trial.
Setting: Six governmental primary care centers in Ulaanbaatar, Mongolia, and outskirts.
Participants: Mongolian adult smokers referred to government-run addiction units.
Intervention and procedures: Participants are randomized to 5 weeks of treatment (n=654) or usual care (n=653) and a 6-month follow-up. The treatment consists of a 25-day course of Cytisine tablets and behavioral counseling. Usual care consists of 25 days of NRT and behavioral counseling.
Measurements: The primary outcome is continuous abstinence (< 5 cigarettes smoked since quit date) at 1 month. Secondary outcomes include 7-day point prevalence abstinence rates and adverse events.
- Conditions
- Nicotine Addiction
- Being tested
- Cytisine, Nicotine Replacement Therapy (NRT)
- Keywords
- Smoking Cessation, Nicotine Replacement Therapy, Cytisine
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytisineDrug
Subjects will take a 25-day course of Cytisine tablets started during the 4 days before the quit date. They will be asked to reduce smoking during this time.
Nicotine Replacement Therapy (NRT)Drug
Subjects are asked to completely stop smoking on their quit day and use a daily NRT patch for 25 days.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Active comparator | Subjects are asked to completely stop smoking on their quit day and use a daily Nicotine Replacement Therapy (NRT) patch for 25 days. Receives: Drug: Nicotine Replacement Therapy (NRT) |
| Treatment Group | Experimental | Subjects will start a 25-day course of Cytisine tablets started during the four days before the quit date and are asked to reduce smoking during this time. Receives: Drug: Cytisine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of abstinence after 25 day course of Cytisine.
Continuous abstinence is defined as <5 cigarettes smoked since quit date. Subjects will complete survey to determine number of cigarettes smoked since quit day.
Measured: One month after quit date
Secondary outcomes (1)
Length of abstinence after 25 days of NRT
Continuous abstinence is defined as <5 cigarettes smoked since quit date. Subjects will complete survey to determine number of cigarettes smoked since quit day.
Measured: One month after quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start27 Jan 2022
- Primary completion4 Mar 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Mongolian National University of Medical Sciences
- Responsible party
- Principal investigator, Pramil N Singh, Loma Linda University
- Investigators
- Pramil N Singh, DrPH, Principal investigator, Loma Linda University HealthDavaalkham Dambadarjaa, MD, Principal investigator, Mongolian National University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126135
- Sponsor's protocol ID
- 5170400
- Status last verified
- Sep 2024
- First submitted
- 11 Oct 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy (NRT) in the National Smoking Cessation Program of Mongolia: A Pragmatic Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT04126135
- Acronym / sponsor ID
- 5170400
- Conditions
- Nicotine Addiction
- Keywords
- Smoking Cessation, Nicotine Replacement Therapy, Cytisine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,307 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Pfizer, Mongolian National University of Medical Sciences
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pragmatic, single blinded, randomized, controlled non-inferiority trial of Cytisine versus Nicotine Replacement Therapy for continuous abstinence is conducted in the government run primary health hospitals in Mongolia.
Detailed description
Rationale: In Mongolia, smoking cessation assistance in the governmental health sector consists of behavioral counseling and a 3-week regimen of the NRT patch that costs 175 USD. This cost for low income adults limits effectiveness. A 2014 study documented the superiority and lower cost (<20 USD) of Cytisine versus NRT for continuous abstinence. Trial investigators are testing the comparative effectiveness of Cytisine in the "real life setting" of their national health care system and, if proven effective, will include coverage for Cytisine in the national health plan.
Research Question/Objective: To determine whether a 25 day course of Cytisine tablets is at least as effective as 25 days of NRT in helping smokers remain abstinent for at least one month.
Design: A pragmatic, single blinded, randomized, controlled non-inferiority trial.
Setting: Six governmental primary care centers in Ulaanbaatar, Mongolia, and outskirts.
Participants: Mongolian adult smokers referred to government-run addiction units.
Intervention and procedures: Participants are randomized to 5 weeks of treatment (n=654) or usual care (n=653) and a 6-month follow-up. The treatment consists of a 25-day course of Cytisine tablets and behavioral counseling. Usual care consists of 25 days of NRT and behavioral counseling.
Measurements: The primary outcome is continuous abstinence (< 5 cigarettes smoked since quit date) at 1 month. Secondary outcomes include 7-day point prevalence abstinence rates and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Drug: Nicotine Replacement Therapy (NRT)Subjects are asked to completely stop smoking on their quit day and use a daily Nicotine Replacement Therapy (NRT) patch for 25 days. |
| Treatment Group | Experimental | Drug: CytisineSubjects will start a 25-day course of Cytisine tablets started during the four days before the quit date and are asked to reduce smoking during this time. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Seeking smoking cessation treatment
- Ages 18 years or older
- Currently smoking > 5 cigarettes per day
- Willingness to make quit attempt with pharmacotherapy
- Able to provide verbal and written informed consent
Key exclusion criteria (5 listed)
- Pregnancy or currently breastfeeding
- Current users of NRT (patch, gum, lozenge)
- Current users of non_NRT smoking cessation pharmacotherapy
- Enrolled in another smoking cessation program (non-governmental)
- Clinical disorder that contraindicates use of NRT or Cytisine (heart attack, stroke, severe angina within the past 2 weeks, uncontrolled hypertension, phaeochromocytoma, severe mental illness)
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 |
|---|---|---|
| CytisineSubjects will take a 25-day course of Cytisine tablets started during the 4 days before the quit date. They will be asked to reduce smoking during this time. | Drug | Treatment Group |
| Nicotine Replacement Therapy (NRT)Subjects are asked to completely stop smoking on their quit day and use a daily NRT patch for 25 days. | Drug | Usual Care Group |
Primary outcome
Length of abstinence after 25 day course of Cytisine.
Time frame: One month after quit date
Continuous abstinence is defined as <5 cigarettes smoked since quit date. Subjects will complete survey to determine number of cigarettes smoked since quit day.
1 secondary outcome
Length of abstinence after 25 days of NRT
Time frame: One month after quit date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Pramil N Singh, DrPH principal investigator
Loma Linda University Health
Davaalkham Dambadarjaa, MD principal investigator
Mongolian National University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cytisine and Nicotine Replacement Therapy (NRT) in people with Nicotine Addiction, run by Loma Linda University at 1 site in Mongolia.
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 6 inclusion and 5 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 19 Sep 2024. 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 Mongolia. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of abstinence after 25 day course of Cytisine. (time frame: One month after quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.