Behaviors and Mental Disorders

All Conditions

Neoplasms

Behavior, Addictive

Neoplasms, Second Primary

Psychotropic Drugs

All Drugs and Chemicals

Central Nervous System Stimulants

Cardiotonic Agents

Bupropion

Nicotine

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.

Patients diagnosed with tobacco-related treatment will receive varenicline and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.

Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.

Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.

Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch), counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.

Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch) and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.

Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.

Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.

Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.

Long-acting nicotine replacement therapy

A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.

Low-intensity counseling

A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.

High-intensity counseling

Participants in this group will not receive per required need nicotine replacement therapy.

No nicotine replacement therapy

Participants in this group will receive per required need nicotine replacement therapy.

Nicotine Replacement Products

Joseph Valentino, MD

David Goebel, MD

Tina Berger

Vanissa Sorrels

Smoking cessation has been shown to improve the effectiveness and reduce the morbidity of tobacco-related cancer treatments. We will identify effective smoking cessation strategies for patients who are receiving treatment for tobacco-related cancer. In this trial, patients' preferences in smoking cessation therapy will be the principal determinant by providers in developing a three component regimen of pharmaceutical therapy, counseling, and nicotine replacement therapy. This study will identify this cohort's preferences for smoking cessation strategies. We will then examine the impact of utilizing patient preferences upon cessation efficacy by directly comparing cessation success in this study with our recently completed study of the same population using the same tobacco treatments which were randomly assigned.

Background Cigarette smoking is associated with decreased survival and decreased efficacy of cancer therapy in those with smoking related malignancies. There is limited of study of smoking cessation for cancer patients being treated in regions with high tobacco use such as Kentucky. There is little study of cessation implementation in the community cancer treatment setting where the majority of cancer patients receive their cancer therapy. Most smokers have significant exposure to information and personal experience with tobacco treatments which, in some cases, leads to profound preferences. The effect of incorporating these patient preferences into tobacco treatment planning has not been studied or quantified.

Study Design Phase II therapeutic clinical trial.

Setting University of Kentucky Markey Cancer Center (MCC) and its affiliate research network of Community Cancer Centers (MCCRN)

Methods Ninety-three subjects will be selected. All subjects will be active smoking oncology patients with a diagnosis of smoking related malignancy who are beginning a new course of therapy. In conjunction with their treating clinician, all subjects will be counseled and then select one of 12 cessation strategies. This will include a choice of continuous pharmacologic agent (veranicline, bupropion or transdermal nicotine patch), counseling strategy (11 session high intensity motivational based counseling or single session low intensity counseling), and whether or not to use as needed nicotine (gum, lozenges or spray).

Data Analysis All subjects will be followed for six months. The primary endpoint will be a carbon monoxide monitoring confirmed negative seven-day point prevalence report of cessation at eight weeks. Data will then be analyzed and compared with a completed randomized clinical trial of the same treatment strategies in the same population of subjects where the cessation strategy was assigned (historical control). The proportion of subjects that have quit at week eight will be compared to the historical control proportion (namely, whether Ho:p=po vs Ha: p\>po). This will be assessed using a z-score for a binomial proportion which will test whether the underlying proportion quitting at eight weeks (p) differs from the control proportion (po ranging from 0.215 to 0.26) estimated from our recently completed randomized trial of these same 12 cessation strategies.

This trial is a parallel design. However, it is part of a broader sequential cohort design to compare the effects of preference driven tobacco treatment upon cessation versus effects of a previous cohort from a separate randomized controlled trial.

Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

Number of patients requiring financial assistance with medication.

Number of patients with alteration in therapy due to ongoing cancer treatment.

Proportion of treatments covered by insurance/third party.

Proportion of participants that quit smoking at the 8 week assessment

Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.

Proportion of participants preferring the treatment plan.

Cigarette use will be recorded at weeks one, four, eight and at 6 months.

Subjects who complete 75% of the planned dosages of therapy will be considered compliant.

Subjects who complete 60% of planned therapy sessions will be considered compliant.

Professor

Compulsive Behavior

Impulsive Behavior

Paramedical professionals of the Lucien Neuwirth Cancer Institute

Semi directive interview will be performed to try to define the management of addictions in the oncology care course. Thus, an approach in terms of social representations among paramedical professional actors involved in the care of patients treated for cancer and with an unresolved addictive disorder sounds the best way for this research.

Semi directive interview

Elise Verot

Nowadays, guidance is given on the implementation of innovative approaches to promote autonomy and user participation through strategies designed to strengthen the patient's empowerment. \[SNS 2018-2022, Ministère des Solidarités et de la Santé\] The 2014-2019 Cancer Plan calls for the systematic support of smokers during smoking cessation. This means that health workers need to be trained to help with smoking cessation, as well as the motivational attitude that reinforces the patient's smoker's self-esteem as well as his desire to off-load this addiction. \[Perriot, Underner, Peiffer, Dautzenberg, 2018\] It is recommended that these interventions be included from the beginning of the management, once the diagnosis of Cancer is made. It seems legitimate then to wonder about the place of choice the Motivational Interview (EM) could have in the course of cancer care, for the management of addictions during the treatment of cancer. We therefore wish to carry out descriptive qualitative research in the Lucien Neuwirth Oncology Institute in order to try to define the management of addictions in the oncology care course. Thus, an approach in terms of social representations among paramedical professional actors involved in the care of patients treated for cancer and with an unresolved addictive disorder sounds the best way for this research.

The Treatment of Addictions in the Course of Care in Oncology: an Inventory of Fixtures Among Paramedical Professionals

We therefore wish to carry out descriptive qualitative research in the Lucien Neuwirth Oncology Institute in order to try to define the management of addictions in the oncology care course. In a first time, number of addiction managements will be reported.

Institut de Cancérologie de la Loire

Anti-Dyskinesia Agents

Escitalopram

Citalopram

Dexetimide

Moclobemide

Selective Serotonin Reuptake Inhibitors

Serotonin

Monoamine Oxidase Inhibitors

antidepressant use for the betel-quid abstinence

escitalopram

Placebo - Cap

Ko Ying-Chin, PHD

No medication existed for BQ dependence. No clinical trials existed for the drug therapy. Previous study showed that BQ possessed the antidepressant effect via pathway of monoamine oxidase A (MAO-A). An animal model also found that the arecoline from BQ has a property as MAO-A inhibitor. Therefore, the investigators hypothesized that inhibition of the MAO-A or antidepressants might reduce the BQ addiction severity.

The investigators will conduct the randomization and double blinded with placebo controlled study with 90 participants with BQ dependence from the Family Medicine and ear, nose, and throat (ENT) outpatient department (OPD). All participants shall agree the informed consent. The range of age is from 18 to 65 years old. The participants are diagnosed as BQ use disorder without other psychiatry co-morbidity, according to the Diagnostic and Statistical Manual (DSM)-V criteria. Those who have severe physical illness, psychiatric illness, and other substance use disorder except cigarettes are excluded. All participants receive the semi-structure interview by DSM-V, International Classification of Diseases (ICD)-10, and Mini International Neuropsychiatric Interview by the psychiatrist. Before the intervention, the participants will finish their basic data, daily amount of cigarettes, betel nut, medical history and psycho-social rating scales. Next, in addition to counseling, the investigators will continue or modify the optimal antidepressants based on the previous results.

The investigators will evaluate their BQ use condition as what has been measured in the natural observation study of the first year. The investigators will check the outcome measurement by visual analog scale, betel quid withdrawal severity scale, Yale-Brown Obsessive-Compulsive (Y-BOCS) - betel quid (BQ) scale. The investigators also followed their hamilton depression scale; Beck depression index; and Beck anxiety index in the baseline, 2nd, 4th, 6th , and 8th week. The investigators also obtained the participants' gene type if the participants also agree for the prediction of oral cancers.

We'll conduct the betel-quid (BQ) dependence clinical trial since 2016. Eligible cases will be enrolled for the following 8 week double-blinded placebo controlled trial. The groups will be divided into three groups. Outcome measures include BQ use condition, addiction severity rating scale, emotional rating scale including Beck Anxiety Index (BAI), Beck Depression Index (BDI), Hamilton Depression Scales (HAMDs), and urine BQ metabolites.

Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer

The betelnut severity rating scale is a questionnaire rated by the psychiatrist or trained psychologist/nurse, containing 21 yes or no questions about betelnut use

Yale-Brown Obsessive Compulsive Disorder-like Scale, translated in Chinese and betelnut use craving form, a questionnaires containing 10 questions rated by the psychiatrist or trained psychologist/nurse, severity from 0-4

arecoline, arecaidine, and N-methylnipecotic acid checked by liquid chromatography mass spectrometry (LC-MS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment	NCT04634071	Smoking Cessati... Cancer, Treatme...	Varenicline Bupropion Long-acting nic... Low-intensity c... High-intensity ... No nicotine rep... Nicotine Replac...	18 Years -	University of Kentucky
Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment	NCT04634071	Smoking Cessati... Cancer, Treatme...	Varenicline Bupropion Long-acting nic... Low-intensity c... High-intensity ... No nicotine rep... Nicotine Replac...	18 Years -	University of Kentucky
The Treatment of Addictions in the Course of Care in Oncology: an Inventory of Fixtures Among Paramedical Professionals	NCT03706937	Paramedical Pro...	Semi directive ...	18 Years -	Institut de Cancérologie de la Loire
Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer	NCT03010761	Addiction	escitalopram Moclobemide Placebo - Cap	14 Years - 70 Years	China Medical University Hospital
Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer	NCT03010761	Addiction	escitalopram Moclobemide Placebo - Cap	14 Years - 70 Years	China Medical University Hospital

Spots Global Cancer Trial Database for addiction

Every month we try and update this database with for addiction cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for addiction

Every month we try and update this database with for addiction cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for addiction cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.