Moderate or Severe Tobacco Use DisorderNCT06439303
Analysis and Evaluation of Smoking Treatment With Cytisine
An observational study of Moderate or Severe Tobacco Use Disorder, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
The lack of clinical studies on the use of Cytisine in the treatment of the cessation of smoking, the need to find effective therapeutic alternatives and the opportunity to reduce costs related to the complications of cigarette smoking, represent the main reasons that led to the design of this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate or Severe Tobacco Use Disorder
- What is being tested?
- Cytisine 1,5 mg
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2024to 20 Jun 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have referred to the Anti-smoking Center of the IRE, National Cancer Institute "Regina Elena", and that meet the following criteria.
Who may be able to join
- patients aged > 18 years;
- patients suffering from moderate or severe tobacco use disorder;
- prescription of pharmacological therapy with Cytisine;
- patients returned to the 1st check-up on schedule;
Who cannot join
- Patients with contraindications to taking Cytisine and partial receptor agonists nicotinic cholinergics;
- Patients undergoing pharmacological or physical treatment for neoplastic pathology;
- Pregnant or breastfeeding women;
- Patients for whom specific information for objective assessments is not available;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Maria Papale, Doctor, 0652666903 ext. +39, maria.papale@ifo.it
About this study
Official title: Analysis and Evaluation of Smoking Treatment With Cytisine: Retrospective Observational Study
The lack of clinical studies on the use of Cytisine in the treatment of the cessation of smoking, the need to find effective therapeutic alternatives and the opportunity to reduce costs related to the complications of cigarette smoking, represent the main reasons that led to the design of this study.
Read the detailed description
The study is observational, retrospective and monocentric, and aims to evaluate patients who performed an initial pneumological examination at the Anti-Smoking Center of the National Institute Regina Elena tumors due to smoking cessation in the reference period. To such patients, affected of moderate or severe tobacco use disorder, drug therapy was prescribed with Cytisine 1.5 mg, with the aim of evaluating treatment adherence, efficacy and tolerability of Cytisine as monotherapy in the treatment of moderate or moderate tobacco use disorder serious. Responding patients will be taken into consideration for the study consecutively to the criteria established and pertaining to the Anti-Smoking Center of the National Cancer Institute Regina Elena in the period between 02/01/2023 and 11/30/2023 on first and subsequent visits controls.
- Conditions
- Moderate or Severe Tobacco Use Disorder
- Being tested
- Cytisine 1,5 mg
- Medical subject headings
- Lymphoma, Follicular, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytisine 1,5 mgDrug
Administration of Cytisine as monotherapy in the treatment of moderate tobacco use disorder or serious
| Study group | Role | What they receive |
|---|---|---|
| Patients with moderate or severe tobacco use disorder. | Patients hospitalized at the IRE anti-smoking center, National Cancer Institute "Regina Elena", suffering from moderate or severe tobacco use disorder, who are prescribed pharmacological therapy with Cytisine 1.5 mg. Receives: Drug: Cytisine 1,5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic adherence
Evaluation of adherence to the prescribed drug therapy i.e. Cytisine 1.5 mg
Measured: 3 months
Secondary outcomes (4)
Evaluation of the effectiveness of the therapy.
Evaluation of the effectiveness of the therapy with the achievement of smoking cessation subsequent checks occurred after clinical evaluation and measurement of the monoxide value exhaled carbon.
Measured: 3 months
Evaluation of therapeutic adherence in relation to motivation.
Evaluation of adherence to Cytisine therapy in relation to the patient's motivation measured with the Mondor motivational test.
Measured: 3 months
Assessment of adherence in relation to the dependency score physics.
Evaluation of adherence to Cytisine therapy in relation to the addiction score physical measured with the Nicotine dependence questionnaire or Fagerström test.
Measured: 3 months
Safety and Tolerability assessment.
Safety and Tolerability assessment describing any adverse reactions related to the intake of Cytisine.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start20 Mar 2024
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate or Severe Tobacco Use DisorderStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439303
- Sponsor's protocol ID
- RS104/IRE/24
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis and Evaluation of Smoking Treatment With Cytisine: Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06439303
- Acronym / sponsor ID
- RS104/IRE/24
- Conditions
- Moderate or Severe Tobacco Use Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 3 Jun 2024 (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.
The lack of clinical studies on the use of Cytisine in the treatment of the cessation of smoking, the need to find effective therapeutic alternatives and the opportunity to reduce costs related to the complications of cigarette smoking, represent the main reasons that led to the design of this study.
Detailed description
The study is observational, retrospective and monocentric, and aims to evaluate patients who performed an initial pneumological examination at the Anti-Smoking Center of the National Institute Regina Elena tumors due to smoking cessation in the reference period. To such patients, affected of moderate or severe tobacco use disorder, drug therapy was prescribed with Cytisine 1.5 mg, with the aim of evaluating treatment adherence, efficacy and tolerability of Cytisine as monotherapy in the treatment of moderate or moderate tobacco use disorder serious. Responding patients will be taken into consideration for the study consecutively to the criteria established and pertaining to the Anti-Smoking Center of the National Cancer Institute Regina Elena in the period between 02/01/2023 and 11/30/2023 on first and subsequent visits controls.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with moderate or severe tobacco use disorder. | – | Drug: Cytisine 1,5 mgPatients hospitalized at the IRE anti-smoking center, National Cancer Institute "Regina Elena", suffering from moderate or severe tobacco use disorder, who are prescribed pharmacological therapy with Cytisine 1.5 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have referred to the Anti-smoking Center of the IRE, National Cancer Institute "Regina Elena", and that meet the following criteria.
Key inclusion criteria (4 listed)
- patients aged > 18 years;
- patients suffering from moderate or severe tobacco use disorder;
- prescription of pharmacological therapy with Cytisine;
- patients returned to the 1st check-up on schedule;
Key exclusion criteria (4 listed)
- Patients with contraindications to taking Cytisine and partial receptor agonists nicotinic cholinergics;
- Patients undergoing pharmacological or physical treatment for neoplastic pathology;
- Pregnant or breastfeeding women;
- Patients for whom specific information for objective assessments is not available;
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 |
|---|---|---|
| Cytisine 1,5 mgAdministration of Cytisine as monotherapy in the treatment of moderate tobacco use disorder or serious | Drug | Patients with moderate or severe tobacco use disorder. |
Primary outcome
Therapeutic adherence
Time frame: 3 months
Evaluation of adherence to the prescribed drug therapy i.e. Cytisine 1.5 mg
4 secondary outcomes
Evaluation of the effectiveness of the therapy.
Time frame: 3 months
Evaluation of therapeutic adherence in relation to motivation.
Time frame: 3 months
Assessment of adherence in relation to the dependency score physics.
Time frame: 3 months
Safety and Tolerability assessment.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate or Severe Tobacco Use Disorder, run by Regina Elena Cancer Institute at 1 site in Italy.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Jun 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 Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Papale, Doctor (0652666903 ext. +39, maria.papale@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic adherence (time frame: 3 months). 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 3 Jun 2024.