A Phase 4 interventional study of Cytisine and Nicotine Replacement Therapy (NRT) in Nicotine Addiction, sponsored by Loma Linda University. Completed at 1 site in Mongolia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Loma Linda University · Phase 4, Interventional, and Treatment
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.
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.
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's enrollment of 1,307 is above the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects are asked to completely stop smoking on their quit day and use a daily Nicotine Replacement Therapy (NRT) patch for 25 days.
Drug: Nicotine Replacement Therapy (NRT)
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.
Drug: Cytisine
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.
Subjects are asked to completely stop smoking on their quit day and use a daily NRT patch for 25 days.
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.
Time frame: One month after quit date
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.
Time frame: One month after quit date
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2022 to primary completion in Mar 2024, 25 months.
Of 38 non-industry phase 4 interventional studies under Tobacco Use Disorder, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 55. This study's 25 months is below that.
Counting every sponsor, half of 38 studies reached it within 41 months; a quarter within 30 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Cytisine