An Open-Label, Phase 2a Single Dose Study in Patients With Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Percentage of patients with treatment emergent adverse events
研究概览
简要总结
An open-label, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamic effects of a single intranasal dose of BPL-003 combined with relapse prevention psychological support, to explore the potential effects on alcohol use and related symptoms in patients with Alcohol Use Disorder.
详细描述
Approximately 12 eligible participants will be receive a single dose of BPL-003, given intranasally, with 12 weeks of follow-up assessments. Psychological support will be given before, during and after dosing
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give informed consent.
- •Age 18 to 64 years at Screening.
- •Diagnosed with moderate to severe AUD.
- •Minimum of 4 heavy drinking days in the 28 days before Screening.
- •No more than 14 days have elapsed since the last HDD or completion of detoxification, with no HDD in the 72 hours prior to dosing and no alcohol at all in the 24 hours prior to dosing
- •Willing to abstain from using recreational drugs from Screening until end of the study
- •Willing to abstain from smoking during their time in the clinic on the day of dosing.
- •Willing to refrain from psychedelic drug use from Screening until the end of the study.
- •Living in stable/secure accommodation in the community.
- •In possession of a personal mobile phone and able to nominate at least one locator individual (eg, a family member, friend, or recovery mentor), with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments.
排除标准
- •Personal or first-degree family history of schizophrenia, bipolar disorder, psychotic disorder, delusional disorder, paranoid disorder or schizoaffective disorder.
- •Any major psychiatric disorders, with the exception of mild or moderate anxiety and/or depression.
- •A clinical diagnosis of post-traumatic stress disorder.
- •Suicide ideation or behaviour or self-injurious behaviours within the 12 months before screening
- •Regular use of or dependence on other drugs other than caffeine or nicotine.
- •Any self-reported use of psychedelic compounds in the past 6 months.
- •History of seizures.
- •Patients who are exhibiting any signs of alcohol withdrawal on dosing day.
- •Positive for alcohol on dosing day.
- •Positive urine drug screen for illicit drugs or drugs of abuse.
- •Any nasal obstruction, blockage, or symptoms of congestion.
- •Any personal or family history of malignant hyperthermia.
- •Patients with an uncontrolled cardiovascular disorder that, in the opinion of the Investigator, may interfere with the interpretation of study results or constitute a health risk for the patient if he/she takes part in the study.
- •Uncontrolled or insulin-dependent diabetes.
研究组 & 干预措施
BPL-003 arm
干预措施: BPL-003 (Drug)
结局指标
主要结局
Percentage of patients with treatment emergent adverse events
时间窗: Up to12 weeks
Percentage of patients with clinically significant abnormal laboratory tests
时间窗: Up to12 weeks
Percentage of patients with suicidal ideation and changes in Columbia Suicidality Rating Scores (CSSRS)
时间窗: Up to12 weeks
Readiness for discharge questionnaire
时间窗: 1 Day
Reactivation Questionnaire
时间窗: Up to 12 weeks
Measure the frequency, emotional valence and functional impact of any re-activation events in the study
Percentage of patients with clinically significant abnormal vital signs
时间窗: Up to12 weeks
次要结局
- Percentage of patients experiencing a complete mystical experience, as assessed by the Mystical Experience Questionnaire (MEQ30)(1 Day)
- Percentage of patients experiencing a an ego dissolution, as assessed by the Ego Dissolution Inventory (EDI)(1 Day)
- Description of the BPL-003 subjective experience data, from a qualitative interview(1 Day)
- Effects on the Ego Dissolution Inventory (EDI)(1 Day)
- Effects on the Mystical Experience Questionnaire (MEQ30)(1 Day)
- Feedback from therapists on the frequency and duration of psychotherapy sessions, therapy manual and overall therapy model(1 Day)