ACTRN12622001306707招募中1 期
Cannabidiol as an Adjunct for the Treatment of Anorexia Nervosa (CAFTAN): An Open Label Pilot Trial with Extension in Young People
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 12 Years 至 18 Years（—）
- 性别
- All
入选标准
- •(a) Females and males aged 12-18 years old
- •(b) DSM-5 diagnosis of anorexia nervosa
- •(c) Referral from MFBT clinician and about to commence MFBT
- •(d) In care of a local GP who agrees to medically monitor patient for the duration of the trial
- •(e) Willingness to provide informed consent and willingness to participate and comply with all the study requirements (Including full medical examination by general practitioner (GP), agree to be monitored by a study doctor via telemedicine, and urine sampling.
- •(f) Ability to read, write and understand English.
- •(g) Availability for the duration of the study.
- •(h) Referral to a MFBT therapist and about to commence routine MFBT (if the young person and family are already engaged in already in MFBT and have not progressed beyond Phase 1, and are willing to change therapist and restart to session 1 of MFBT they may be eligible to be included in the trial).
- •(i) Under an eating disorder plan.
排除标准
- •1.Participants with a known hypersensitivity or allergy to cannabinoids, including prior clinically significant side effects to cannabis, cannabinoid products or synthetic cannabinoids.
- •2.Participants with BMI less than 14.
- •3.Participants with co-occurring physical health conditions (e.g. diabetes, hyperthyroidism, bowel disease). For the purpose of this study, defined as the presence of an uncontrolled, physical health condition as assessed by a medical doctor (i.e., via a verbal medical history and physical examination).
- •4.Participants with a past or present history of cannabis dependence as per the ICD-10 criteria.
- •5.The following medication(s) can possibly have drug-drug interactions with CBD and may cause side effects. Participants on such medications will be excluded from participating in this clinical trial:
- •Topiramate
- •Rufinamide
- •Esclicarbezepine
- •Amiodraone
- •Levothyroxine
- •Other anti-epileptic drugs (AEDS)
- •Other medications that are major inducers or inhibitors of CYP enzyme systems
- •6.Participants who have previously completed MFBT
- •7.Participants currently in MFBT who have progressed to Phase 2
- •8.Participants with a history or active major psychiatric disorder associated with schizophrenia, psychosis, bipolar disorders or suicide risk.
- •9.Participants with a current treatment of antipsychotic medication or mood stabilisers.
- •10.If on antidepressant medication, participants who are not on a stable dose for a minimum of 8 weeks prior to start of the study.
- •11.Participants treated under the Mental Health Act or under compulsory treatment orders.
- •12.Participants with a history of drug or alcohol dependency or abuse within the past 2 years.
- •13.Participants with a history of confirmed seizures or other neurological disorders.
- •14.Lactating or pregnant women or women intending or attempting to conceive during the trial period
- •15.Participants with cognitive impairment or insufficient English or literacy to complete study processes.
- •16.If participant continues to display medical instability, with hospitalisations, investigational drug intervention will be discontinued.
- •17.Participants required to complete mandatory drug testing for cannabis (e.g., workplace testing, court order).
- •18.Participants who have been enrolled in a clinical trial and received an investigational medicinal product within the last 3 months.
研究者
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