Advancing Pregnenolone as a Novel Therapy for Co-Occurring Cannabis Use Disorder and Depression
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percent Days of Cannabis Use
研究概览
简要总结
This is UG3 phase of a multi-site, milestone-driven UG3/UH3 research program evaluating pregnenolone for individuals with co-occurring cannabis use disorder (CUD) and major depressive disorder (MDD). Pregnenolone is a neurosteroid that modulates cannabinoid receptor signaling and may reduce cannabis-related effects while also improving mood-related symptoms.
The primary objective of the UG3 phase is to establish feasibility and generate preliminary data to support a subsequent UH3 randomized clinical trial. Key preparatory activities include obtaining regulatory approvals (including FDA Investigational New Drug [IND] protocol amendment and Institutional Review Board approvals), harmonizing study procedures across participating sites, and implementing data management and monitoring systems.
The UG3 phase includes two main components. First, a pharmacokinetic study willcharacterize pregnenolone pharmacokinetics in adults with CUD and MDD, including measures such as half-life and clearance. Second, a pilot clinical study will evaluate the feasibility, safety, and tolerability of pregnenolone administered orally over approximately 12 weeks. Feasibility outcomes include recruitment rates, retention, and adherence to study procedures, while safety and tolerability will be assessed through adverse event monitoring and discontinuation rates.
Participants will be adults aged 18 to 50 years with diagnoses of cannabis use disorder and major depressive disorder, who report frequent cannabis use and express interest in reducing their use. Clinical assessments of cannabis use, mood symptoms, and related behavioral outcomes will be collected.
The UG3 phase will be used to refine study procedures, inform dosing strategies, and establish benchmarks necessary for progression to the UH3 phase. The subsequent UH3 phase will involve a multi-site, randomized, double-blind, placebo-controlled trial evaluating the efficacy of pregnenolone in reducing cannabis use and improving depressive symptoms in this population.
详细描述
This study represents the UG3 phase of a multi-site, milestone-driven UG3/UH3 research program evaluating pregnenolone as a novel pharmacotherapy for individuals with co-occurring cannabis use disorder (CUD) and major depressive disorder (MDD). Pregnenolone is a neurosteroid that modulates cannabinoid receptor signaling and may reduce cannabis-related effects while also improving mood-related symptoms.
The primary objective of the UG3 phase is to establish feasibility and generate preliminary data to support a subsequent UH3 randomized clinical trial. Key preparatory activities include obtaining regulatory approvals (including FDA Investigational New Drug [IND] protocol amendment and Institutional Review Board approvals), harmonizing study procedures across participating sites, and implementing data management and monitoring systems.
The UG3 phase includes two main components. First, a pharmacokinetic study will be conducted to characterize pregnenolone pharmacokinetics in adults with CUD and MDD, including measures such as half-life and clearance. Second, a pilot clinical study will evaluate the feasibility, safety, and tolerability of pregnenolone administered orally over approximately 12 weeks. Feasibility outcomes include recruitment rates, retention, and adherence to study procedures, while safety and tolerability will be assessed through adverse event monitoring and discontinuation rates.
Participants will be adults aged 18 to 50 years with DSM-5 diagnoses of cannabis use disorder and major depressive disorder, who report frequent cannabis use and express interest in reducing their use. Standardized clinical assessments of cannabis use, mood symptoms, and related behavioral outcomes will be collected.
Data obtained during the UG3 phase will be used to refine study procedures, inform dosing strategies, and establish benchmarks necessary for progression to the UH3 phase. The subsequent UH3 phase will involve a multi-site, randomized, double-blind, placebo-controlled trial evaluating the efficacy of pregnenolone in reducing cannabis use and improving depressive symptoms in this population.
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)
盲法说明
This is a double-blind study in which participants, care providers, investigators, and outcomes assessors are masked to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 50 years
- •Diagnosis of cannabis use disorder according to DSM-5 criteria
- •Diagnosis of major depressive disorder according to DSM-5 criteria
- •Cannabis use on at least 4 days per week in the past 4 weeks
- •Positive urine screen for tetrahydrocannabinol (THC)
- •Willingness to reduce cannabis use
- •Medication-free or on a stable dose of antidepressant medication
- •Able to provide informed consent
排除标准
- •Current diagnosis of other substance use disorders (except nicotine)
- •Current or past diagnosis of psychotic disorders, bipolar disorder, or severe psychiatric conditions
- •Significant or unstable medical conditions that would interfere with study participation
- •Pregnant or breastfeeding
- •Active suicidal or homicidal ideation requiring immediate intervention
- •Use of medications that may interfere with study drug or outcomes, unless stable
- •Allergy or sensitivity to pregnenolone or related compounds
- •History of hormone-sensitive cancer or tumor
结局指标
主要结局
Percent Days of Cannabis Use
时间窗: 12 weeks
The Timeline Follow Back (TLFB) interview will be used to assess cannabis use. The percent days of cannabis use will be the primary outcome measure.
次要结局
- Depressive Symptom Severity(12 Weeks)
- Marijuana Craving(12 Weeks)
研究者
Sherwood Brown, MD, PhD
Professor
University of Texas Southwestern Medical Center