Lemborexant as a Potential Pharmacotherapy for the Treatment of Cannabis Use Disorder (CUD)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Feasibility: Participant Recruitment Rate
研究概览
简要总结
The goal of this clinical trial is to investigate the use of Lemborexant as a treatment for moderate to severe Cannabis Use Disorder (CUD). The main questions it aims to answer are:
- Is Lemborexant safe, feasible, and tolerable to use in the CUD population?
- Will the use of Lemborexant for CUD help to decrease cannabis use, improve sleep, decrease cannabis withdrawal symptoms, and improve cognition?
Researchers will compare 10mg Lemborexant to placebo.
Participants will:
- Take 10mg Lemborexant (or placebo) nightly for 21 nights (treatment phase).
- Wear an actigraphy watch continuously for the treatment phase.
- Complete a pre-screen survey, attend an in-person screening session, 4 in-person lab visits (weekly from days 0-21), and a virtual follow-up visit 2 weeks after the treatment phase.
- Complete a short daily survey for 35 days total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe Cannabis Use Disorder.
- •Ability to read/write in English.
排除标准
- •Known allergies or hypersensitivities to Lemborexant.
- •Use of any Orexin-Antagonist in the past 3 months.
- •Current or recent (within the past 12 weeks) participation in a clinical trial involving medication administration.
- •Narcolepsy, Complex sleep behaviors, sleep apnea, restless leg syndrome, and Periodic Limb Movement Disorder.
- •Currently undergoing treatment for CUD.
- •Any hospitalization or emergency department visit related to cannabis use.
- •Moderate to severe hepatic impairment.
- •Past or ongoing moderate to severe psychiatric disorders.
- •Active suicidal ideation or serious attempt within the past 3 years.
- •Epilepsy or history of seizures.
- •Blood pressure over 160/95mmHg at the screening session.
- •Current pregnancy or nursing, trying to become pregnant, or unwilling to use acceptable method of contraception during the study.
研究组 & 干预措施
Lemborexant 10mg
干预措施: Brief Behavioural Intervention (Behavioral)
Placebo
干预措施: Placebo (Drug)
Placebo
干预措施: Brief Behavioural Intervention (Behavioral)
Lemborexant 10mg
干预措施: Lemborexant 10mg (Drug)
结局指标
主要结局
Feasibility: Participant Recruitment Rate
时间窗: From first participant in until study closure (estimated 24 months).
Measured by assessing the number of participants recruited into the study (28 anticipated) throughout study duration (24 months estimated).
Feasibility: Participant Retention Percentage
时间窗: From first participant in until study closure (estimated 24 months).
Measuring the number of participants who complete the study compared to the total number of study participants, displayed as a percentage (%).
Tolerability: Participant Drop-Out Rates
时间窗: From first participant in until study closure (estimated 24 months).
Measured by comparing frequency of participant drop-outs in treatment versus control groups.
Safety: Adverse Event Frequency
时间窗: Participants will have the opportunity to report adverse events daily during the study treatment phase (days 0-21).
Measured by comparing the frequency of adverse events in the treatment versus control groups.
Safety: MADRS-S Depression
时间窗: The MADRS-S will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).
Measured using the Montgomery-Åsberg Depression Rating Scale - Self Report (MADRS-S) which scores depression from 0-54, with higher scores indicating worse depression.
Safety: C-SSRS Suicidality
时间窗: The C-SSRS will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).
Measured using the Columbia Suicide Severity Rating Scale (C-SSRS), which uses Yes/No answers to categorize into No, Low, Moderate, or High risk.
次要结局
- Sleep (Objective): Actigraphy Data(Measured continuously during the study treatment phase (days 0-21).)
- Sleep (Subjective): PSQI(The PSQI will be administered at pre-screening and day 21.)
- Sleep (Subjective): LSEQ(Participants will take the LSEQ on days 0, 7, 14, and 21 throughout the study treatment phase (days 0-21).)
- Sleep (Subjective): Daily Diaries CSD(Daily diaries will be completed daily during the study treatment phase (days 0-21).)
- Cannabis Use (Objective): Plasma THC and Metabolites(Blood draws will occur on days 0 and 21 during the study treatment phase (days 0-21).)
- Cannabis Use (Subjective): EC-TLFB(The EC-TLFB will be administered on days 0, 7, 14, and 21 during the study treatment phase (days 0-21).)
- Cannabis Use (Subjective): Daily Diaries(Daily diaries will be completed daily during the study treatment phase (days 0-21).)
- Cannabis Use (Subjective): DFAQ-CU(The DFAQ-CU will be administered on days 0 and 21 during the study treatment phase (days 0-21).)
- Cannabis Withdrawal: Daily Diaries Modified MWC(Daily diaries will be completed daily during the study treatment phase (days 0-21).)
- Cognition: Divided Attention(Divided attention cognitive tasks will be administered on days 0 and 21 during the study treatment phase (days 0-21).)
- Cognition: Working Memory(N-back and word memory tasks will be administered on days 0 and 21 during the study treatment phase (days 0-21).)
- Cognition: Planning via Tower of London(Tower of London will be administered on days 0 and 21 during the study treatment phase (days 0-21).)