A Phase 2, Multicenter, Randomized, Double-Blind, Multiple-Dose, Placebo Controlled Clinical Trial of Two Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 18
- 主要终点
- Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days
研究概览
简要总结
This study will be a randomized, double-blind, placebo-controlled, multicenter trial conducted to evaluate whether PP-01 mitigates the withdrawal symptoms associated with discontinuing cannabis in participants with moderate to severe Cannabis Use Disorder (CUD). The study will enroll approximately 225 participants with moderate to severe CUD and will include 5 arms, including a placebo arm, to help assess the incidence and severity of withdrawal symptoms in heavy long-term users of cannabis. Participants receive study medication for 34 days and participate in 11 visits (7 at a clinic and 4 telemedicine).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generally healthy individuals between the ages of 18 and 55, inclusive
- •Meets Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for current moderate to severe CUD as confirmed by a licensed physician or psychologist or addiction medicine specialist
- •BMI within 18.0 to 38.0 kg/m2, inclusive
- •Seeking to minimize withdrawal symptoms related to cannabis discontinuation in people seeking to discontinue cannabis
- •Meet DSM-5 Cannabis Withdrawal
- •Report heavy use of daily/near daily cannabis
- •Have a urine drug screen positive for tetrahydrocannabinol (THC)/THC metabolites at Screening and Randomization
- •Capable of giving informed consent and complying with study procedures
- •Stated willingness to comply with all study procedures including twice weekly visits, daily evening video calls, restrictions, and availability for the duration of the study
排除标准
- •Lifetime history of DSM-5 diagnosis of schizophrenia or schizoaffective disorder, or Bipolar 1 within the previous 2 years
- •Current DSM-5 criteria for a psychiatric disorder that in the Investigator's judgment is unstable, would be disrupted by the study medication, or is likely to require new pharmacotherapy or psychotherapy during the study period. Individuals who are currently stable on psychotropic medication for at least 3 months may be included at the discretion of the Investigator's judgement
- •Participants who meet DSM-5 criteria for any substance use disorder other than cannabis, nicotine, or caffeine use disorders
- •Participants using cannabis for a medical condition requiring use such as epilepsy
- •Clinically significant unstable medical disorders
- •Any clinically important abnormalities on Screening physical examination (PE), assessments, ECG, or laboratory tests
- •Use of an investigational drug or biologic within 30 days or 5 times the half-life (whichever is longer) prior to the Screening Visit
- •Pregnant or lactating female participants, or a positive urine pregnancy test
研究组 & 干预措施
PP-01 High Dose
Oral PP-01 High Dose tapered/titrated over 34 days
干预措施: PP-01 High Dose (Combination Product)
PP-01 Low Dose
Oral PP-01 Low Dose tapered/titrated over 34 days
干预措施: PP-01 Low Dose (Combination Product)
Placebo
Oral placebo, given daily for 34 days
干预措施: Placebo (Drug)
Nabilone
oral nabilone, tapered/titrated over 28 days
干预措施: Nabilone (Drug)
Gabapentin
oral gabapentin, tapered/titrated over 34 days
干预措施: Gabapentin (Drug)
结局指标
主要结局
Evaluation of a patient reported outcome measure of cannabis withdrawal over 5 days
时间窗: Over 5 days
次要结局
未报告次要终点