2022-500085-96-00招募中3 期
NAlmefene versus placebo in addition to treatment as usual on craving in Behavioural Addictions (NABAb)
Centre Hospitalier Universitaire De Nantes13 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2022年8月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 266
- 试验地点
- 13
- 主要终点
- Variation of averaged intensity of craving episodes between start (during the week preceding initiation of treatment) and end (during the week preceding end of treatment) of treatment. Each craving episode will be reported by the patient on a weekly diary, with intensity assessed through a Numerical Rating Scale (NRS).
研究概览
简要总结
To assess the efficacy of nalmefene versus placebo as an add-on to treatment as usual for reducing intensity of craving episodes in patients with Behavioural Addictions (Gambling Desorder, Sexual Addiction, Food Addiction), at the end of treatment at maximum dosage tolerated.
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall study
- 盲法
- Double (Subject, Analyst, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Males and females ≥ 18 years old
- •Patient already in care or newly initiating care in Addictology departments for a behavioural addiction, diagnosed with current : - Gambling disorder / - Food addiction / - Or Sexual addiction.
- •Able to regularly assess and report their craving episodes on a weekly diary
- •Who provide their written informed consent
- •Affiliated with French social security system or beneficiary from such system
- •Having presented at least one episode of craving with an intensity ≥ 4/10 at the NRS during the week prior to inclusion
- •Women must meet one of the following criteria at the time of inclusion: use adequate contraceptive measures as recommended by the CTFG, and have a negative pregnancy test prior to receiving the first dose of study drug; or be post-menopausal (over 50 years of age with amenorrhea for at least 12 months after discontinuation of all exogenous hormonal therapy); or (if under 50 years of age) have been amenorrheic for at least 12 months after discontinuation of exogenous hormonal therapy and with luteinizing hormone and follicle stimulating hormone levels corresponding to post-menopausal levels; or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy.
排除标准
- •Being currently treated by another anti-craving drug that have been already tested for craving reduction in BAs (naltrexone, acamprosate, baclofène, topiramate, bupropion, N-acetyl-cystéine, disulfiram, etc.)
- •Anorexia nervosa-restricting type (because food addiction concept is poorly established among patients with AN-R, who do not have binge eating episodes induced by craving)
- •Extreme leanness (body mass index < 16.5) (because loss of appetite and/or weight loss are frequent adverse effects of nalmefene)
- •Current treatment with potent inhibitor drugs of the UGT2B7 (UDP-Glucuronosyltransferase-2B7); for example: diclofenac, fluconazole, medroxyprogesterone acetate, meclofenamic acid
- •Current treatment with UGT inducing drugs; for example: dexamethasone, phenobarbital, rifampicin, omeprazole
- •Inability to indicate the time of day of the most intense craving episode (because this information will determine the time of day the treatment should be taken)
- •Pregnancy (attested by a pregnancy urinary test for women of childbearing age) or breastfeeding woman
- •Trusteeship
- •Major cognitive impairment
- •Not fluent in French
- •Participation to another interventional study during the last month or expected participation to another interventional study during participation to the NABAB study
- •Presenting a contraindication for the use of nalmefene (listed in the SmPC) : - Known hypersensitivity to the active substance or to any of the excipients. In particular, intolerance to galactose or deficiency in Lapp lactase or glucose-galactose malabsorption (rare hereditary diseases) / - Treatment by opioid agonists (full or partial) (opioid pain relievers, opioid substitution drugs) / - Recent history of opioid dependence or current opioid dependence / - Current symptoms of the acute opioid withdrawal syndrome / - Suspected recent consumption of opioid (necessity to consider the half-life) / - Severe hepatic impairment (Child-Pugh stage B or C) / - Severe renal impairment (estimated glomerular filtration rate [TFGe] <30 mL/min/1.73 m2 ) / - History of recent acute alcohol withdrawal syndrome (including hallucinations, convulsions and delirium tremens).
- •Predictable opioid treatment during the study period
- •Unstable psychiatric disorders (meaning disorders for which the treatment was modified since less than a month (corresponding to the instauration of a new treatment, or the increase in dosage of a treatment already being taken)), including severe risk of suicide (i.e. necessity to engage specific medication or hospitalization; psychotropic medication engaged since less than 1 month; absence of improvement after one month of medication) (because nalmefene has not been studied in patients with unstable psychiatric disorders). Patients with a food addiction diagnosed with eating disorders marked by the presence of binge eating can be included
结局指标
主要结局
Variation of averaged intensity of craving episodes between start (during the week preceding initiation of treatment) and end (during the week preceding end of treatment) of treatment. Each craving episode will be reported by the patient on a weekly diary, with intensity assessed through a Numerical Rating Scale (NRS).
Variation of averaged intensity of craving episodes between start (during the week preceding initiation of treatment) and end (during the week preceding end of treatment) of treatment. Each craving episode will be reported by the patient on a weekly diary, with intensity assessed through a Numerical Rating Scale (NRS).
次要结局
- Variation of averaged weekly frequency (number of episodes) and duration (cumulative duration of all episodes) of craving episodes between start and end of treatment.
- Variation of averaged weekly intensity, frequency and duration of craving episodes between start of treatment and 4 weeks after the end of treatment.
- Variation of averaged weekly frequency, duration and intensity (assessed through a NRS) of the BA episodes: (i) between start and end of treatment and (ii) between start of treatment and 4 weeks after the end of treatment.
- Overall clinical improvement, assessed though the Clinical Global Impression – Improvement (CGI-I) scale and the GGI – Efficacy Index (CGI-EI).
- Variation of averaged weekly use of psychoactive substances (including nicotine) and daily life behaviors of interest (gambling, sex, food) between start of treatment and 4 weeks after the end of treatment.
- Number, type and severity of self-reported adverse side effects, during either weeks of treatment at a dosage of 18 mg/d or 36 mg/d.
- Mutation(s) associated with non-response to nalmefene treatment; such mutations will be identified using a NGS (Next-Generation Sequencing) panel.
- Sociodemographic, medical and clinical data, especially psychiatric and addictive co-morbidities assessed with the Mini International Neuropsychiatric Interview – Simplified (MINI-S) and the age of the BA
研究者
Marie GRALL-BRONNEC
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (13)
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