ACTRN12624000343505招募中1 期
Toward Embodied Healing: Feasibility of a Psilocybin-Assisted Psychotherapy for Women with Partially Recovered Anorexia Nervosa and Persistent Body Image Disturbance. A Manualised, Three-Dose, Open-Label Case Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
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
- 21 Years 至 o limit（—）
- 性别
- Female
入选标准
- •* Adults aged 21+
- •* Female (assigned female at birth and currently identify as female gender).
- •* Have previously met criteria for anorexia nervosa, as per DSM-5 criteria (with BMI less than 18.5 at time of diagnosis)
- •* Current BMI greater than or equal to 18.5kg/m2 sustained for minimum six months
- •* Medically stable (as confirmed by care team (psychiatrist or GP). Medical stability is determined by:
- •- Systolic BP greater than or equal to 90
- •- HR greater than 50 and less than 100
- •- No significant postural tachycardia or hypotension
- •- Normal ECG
- •- Normal electrolytes
- •* Body image disturbance as determined by a score of 3 on either the weight concern subscale or shape concern subscale (or both subscales) of the EDE-Q
- •* At least one previous treatment for eating disorder
- •* Current/past treatments have not led to remission from body image disturbance
- •Minimum duration for BID for six months
- •* Under the care of a psychiatrist, psychologist, physician or GP
- •* Identified caregiver/support person who agrees to participate in study and can commit their availability for the duration of the study; and participant consents to have research team maintain contact with nominated support person for the duration of the study
- •* Capacity to provide consent, as determined by sufficient proficiency in English (literacy and comprehension are sufficient to understand consent form and study questionnaires, as evaluated by study staff obtaining consent)
- •* Participants who can agree to a safely tapered and washed-out serotonergic medications prior to baseline assessment (as confirmed by treating medical doctor)
- •* Participants agree to refrain from psychoactive drugs, nutritional or herbal supplements, and alcohol use for minimum 48 hours prior to each dose of psilocybin.
- •* Participants can commit their availability for the duration of the study
- •* Participants who agree to have their drug dosing sessions recorded to video for treatment fidelity and clinical supervision within the study team.
- •* Participants who can swallow tablets.
排除标准
- •General medical exclusion criteria:
- •- History of neurological conditions (e.g. epilepsy, other seizures) or any disorder with known CNS involvement, or other major CNS disease.
- •- History of diabetes
- •- History of cardiovascular disease
- •- Uncorrected hypo- or hyperthyroidism
- •- Abnormal serum electrolytes
- •- Raised cardiac enzymes
- •- Abnormal QT interval prolongation at screening or prior history
- •- Hypertension
- •- Hepatic dysfunction as indicated by the following values:
- •-- GGT > 3 x ULN (upper limit of norm)
- •-- AST > 3 x ULN
- •-- ALT > 3 x ULN
- •-- Tot Bili > 3.0 mg/dL
- •- Known conditions putting participant at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome.
- •- Cardiovascular conditions: uncontrolled hypertension (Systolic >140 and diastolic >90), angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), TIA in the last 6 months, stroke, or cerebrovascular disease, peripheral or pulmonary vascular disease (no active claudication). This could include patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440 ms for men and above 470 ms for women).
- •- Renal insufficiency (creatinine clearance < 40 mL/min using the Cockcroft and Gault equation).
- •- Participants who weigh less than 40kg
- •- Participants who are pregnant or nursing or are trying to get pregnant, or become pregnant during the study
- •- If sexually active, participants who cannot commit to appropriate contraception for duration of the study
- •- Self-induced vomiting > 3 episodes per week
- •- Purging > 3 episodes per week
- •- History of laxative abuse in past 3 months
- •- Current or previous rapid weight loss (>4kg weight loss in past month; >2kg weight loss during study)
- •- Long-acting opioid pain medications (e.g., oxycodone sustained release, morphine sustained release -- which are usually taken at 12-hour intervals) will be allowed if the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration.
- •- Participants will be excluded if, at the time of recruitment, they are taking a contraindicated medication (SSRIs, SNRIs, MAOIs), and either 1) do not wish to be tapered off this medication, or 2) trial psychiatrists or the participant’s usual treatment team determine that tapering the participant off their current medication would be inappropriate for their health/safety.
- •- Participants will be excluded if they are currently using any of the following potent metabolic inducers or inhibitors: Inducers - Rifamycin (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, paclitaxel, St John's Wort; Inhibitors - all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin.
- •- Participants will be excluded if it is a medical requirement that they receive any of the following drugs with low therapeutic index within 12 hours after receiving psilocybin: ergot alkaloids, pimozide, diazepam, temazepam, lorazepam, midazolam, triazolam, lovastatin, simvastatin, fentanyl.
- •Psychiatric exclusion criteria:
- •- Current or past history of psychiatric conditions encompassing mania or psychosis, including: schizophrenia; psychotic disorder; bipolar I or bipolar II disorder; mania - as determined by DSM-5
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