EUCTR2012-002731-28-PL进行中（未招募）不适用
Randomized placebo controlled trial assessing the efficacy and safety of BP1.4979 in smoking cessation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Bioprojet
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. males or females, aged 18 to 65 years old
- •2. 18 kg/m2 = BMI = 35 kg/m2
- •3. a smoking history of at least 10 years
- •4. subject smoking at least 15 cigarettes per day at the time being and for at least 30 days before selection.
- •5. motivated to quit smoking with a motivation test score > 12 on the Legeron and Lagrue Questionnaire of Motivation (Q-MAT) at the selection and at the inclusion
- •6. having already made at least 2 attempts to stop (each of at least 7 days), including at least one attempt with medical and pharmacological
- •treatment, at least 30 days before the selection
- •7. with no period of abstinence > 3 months in the previous year
- •8. Fagerström Test of Nicotine Dependence (FTND) ? 7 at V0 (screening) and/or at V1 (randomization)
- •9. not taking anti-smoking medication
- •10. not taking antipsychotic medication, antidepressant except Selective Serotonin Reuptake Inhibitors (SSRIs) prescribed for at least one month (e.g. fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram, venlafaxine, milnacipran, duloxetine) and/or any other psychotropic medication except benzodiazepine treatment stable for at least one month prior to inclusion in the study.
- •11. females of child-bearing potential must use a medically accepted effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding subject.
- •12. in the opinion of the investigator, the subject must have adequate
- •support to comply with the entire study requirements as described in the protocol (e.g. transportation to and from trial site, self rating scales,
- •drug compliance, scheduled visits, etc).
- •13. subject must have voluntarily expressed willingness to participate in this study, understand protocol procedures and have signed and dated an informed consent prior to beginning any protocol required
- •procedures.
- •14. attend usual smoking cessation counseling provided by investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. any significant psychiatric illness (schizophrenia, bipolar disorder, severe depression, dementia...) or mood disorder, assessed by the Beck
- •Depression Inventory (BDI) (exclusion if ? 8 and/ or item G ? 0).
- •2. Hospital Anxiety and Depression (HAD) scale (A + D = 19, the day of the selection and inclusion).
- •3. substance use disorder (except nicotine).
- •4. Alcohol Use Disorders Identification Test (AUDIT) ? 8.
- •5. any use of non prescription opiates / stimulants (amphetamines),
- •cocaine or cannabis in the 3 previous months.
- •6. positive urinary test on opiates, amphetamine, cannabis or cocaine.
- •7. other active clinically significant illness, including unstable
- •cardiovascular, or neoplasic pathology which could interfere with the study conduct or counter-indicate the study treatments or place the
- •subject at risk during the trial or compromise the study participation.
- •8. subject with a known history of long QTc syndrome (e.g. syncope or
- •arrhythmia) or presenting any significant serious abnormality of the ECG (e.g. recent myocardial infarction), or QTcB interval strictly higher than 450 ms for man and 460 ms for woman (electrocardiogram Bazett's corrected QT interval: QTc=QT/? [60/HR]).
- •9. subject with severe hepatic impairment or with severe renal
- •impairment, or with any other significant abnormality in the physical examination or clinical laboratory results (e.g positive laboratory test for Hepatitis B surface antigen (HBsAg), or anti-HIV 1/2 or anti- HCV antibodies).
- •10. known hypersensitivity to the tested treatment including active
- •substance and excipients.
- •11. subject smoking cigars or pipes in addition to cigarettes (patient
- •should have stopped cigars or pipes at least 30 days before V0)
- •12. subject taking any antismoking medication (e.g. bupropion,
- •varenicline, clonidine, cytisine..), and/ or Nicotine Replacement Therapy (NRT) in the previous month.
- •13. subject taking antipsychotic medication, or antidepressants other
- •than SSRIs (SSRIs taking for at least one month).
- •14. subject taking anxiolytics (except benzodiazepines at stable dose for
- •at least 1 month).
- •15. subject taking any prescription drug containing amphetamines.
- •16. subject on anti smoking targeted Cognitive Behavioral Therapy (CBT)
- •or any antismoking oriented psychotherapy or acupuncture or using an electronic cigarette.
- •17. subject participating in another study and the use of any
- •investigational therapy within the 30 days prior to the entry in this study.
- •18. subject without any medical care insurance.
- •19. pregnant woman or a pregnancy detected with a positive serum pregnancy test performed at the screening visit.
- •20. male subject who wants to conceive a child for the whole duration of the study.
研究者
相似试验
进行中（未招募）
不适用
Smoking cessatioSmoking cessationMedDRA version: 16.1Level: LLTClassification code 10008374Term: Cessation of smokingSystem Organ Class: 100000004869EUCTR2012-002731-28-CZBioprojet350
进行中（未招募）
4 期
Is pramipexole effective as an add-on treatment for people with treatment-resistant depression?ISRCTN84666271niversity of Oxford178
尚未招募
2 期
Study to evaluate the efficacy of Parikara Yoga (An Ayurvedic polyherbal formulation) and Dietary regimen in the Management of Non-Alcoholic Fatty Liver Disease (NAFLD)CTRI/2023/08/055977ational Institute of Ayurveda Deemed to be University, Jaipur
已完成
不适用
Study to see if steroids reduce kidney problems in Henoch Schonlein purpuraHenoch Schonlein PurpuraHaematological DisordersAllergic purpuraISRCTN71445600niversity Hospital of Wales NHS Trust (UK)368
尚未招募
3 期
A study to assess the role of indicated Homoeopathic medicines for management of pain in the cases of Calcaneal SpurCTRI/2024/04/065561Dr M P K Homoeopathic Medical College Hospital And Research Centre