Pilot Study to Assess the Feasibility of Prazosin for Cannabis Use Disorder in Individuals With or Without Post-traumatic Stress Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Retention
研究概览
简要总结
Cannabis use disorder (CUD) is a significant and expanding health problem, and no FDA approved treatments are currently available. Persons with posttraumatic stress disorder (PTSD) may use cannabis to help control symptoms. Relief from PTSD insomnia, nightmares, anxiety, and preoccupying thoughts have been reported as troublesome symptoms targeted by cannabis users. Risks from cannabis use by individuals with PTSD have been reported. Chronic use of cannabis can lead to tolerance, requiring increased use for symptom relief, and withdrawal symptoms upon stopping. CUD is more frequent and severe in those with PTSD than those without. Many symptoms of cannabis withdrawal overlap with troubling symptoms of PTSD and thus may be interpreted as a relapse of PTSD symptoms. Those attempting to reduce or stop cannabis use may experience cannabis withdrawal symptoms including insomnia and distressing dreams, anxiety, irritability, and/or excessive sweating that they may misattribute to re-emerging or untreated PTSD symptoms.
Excessive brain adrenaline activity is arguably the best-described neurobiological contribution to the pathophysiology of PTSD. Prazosin, a drug that blocks the negative effects of brain adrenaline, has demonstrated effectiveness in robustly reducing PTSD-related nightmares and sleep disturbance in active duty Servicemembers and recently discharged combat Veterans in most, but not all, clinical trials, as well as in civilians with non-combat trauma. Clinically, the investigators have observed that several patients with PTSD using cannabis to treat insomnia and/or trauma-related nightmares and wanting to reduce their cannabis use were able to achieve reduction or cessation of cannabis use once they were treated with an effective dose of prazosin. Therefore, we have wondered if prazosin may provide sufficient treatment of PTSD symptoms otherwise targeted by cannabis, supporting those individuals' efforts to reduce cannabis use.
This open-label pilot study aims to study the feasibility of prazosin as a treatment for CUD in individuals with or without comorbid PTSD, and to evaluate if additional research on a larger scale is warranted.
详细描述
This pilot study aims to assess the feasibility of prazosin as a treatment for CUD in individuals with or without comorbid PTSD, and to evaluate if additional research on a larger scale is warranted. In particular, the investigators will evaluate their ability to recruit and retain individuals with CUD, evaluate their ability to quantify cannabis use and associated clinical outcomes, and objectively measure cannabis use in context of a clinical trial.
Although the investigators have ample experience recruiting Veterans and non-Veterans with and without PTSD for prazosin clinical trials of similar duration, they have never recruited treatment-seeking CUD participants. Treatment studies in cannabis users are known to have approximately 30% drop out rate, and thus gaining experience in recruitment and retention is critical prior to investment in larger studies.
Specific Aim 1: Assess the feasibility of recruitment and retention of participants for a clinical trial using prazosin as a treatment of CUD.
The investigators will recruit 20 treatment seeking individuals with CUD (10 with and 10 without PTSD) for 12-week open label treatment of prazosin. Given their experience conducting studies in Veterans and non-Veterans with and without PTSD and/or alcohol use disorder (AUD) achieving 61-83% retention at end of treatment, the investigators anticipate that prazosin will be well tolerated in the study population. Participants will be asked to provide qualitative assessments of treatment acceptability, or reasons for early termination for those who drop out of the study before end of treatment, so that these issues can be addressed in future study design.
Specific Aim 2: Assess the feasibility of quantifying cannabis consumption by subjective self-report and objective urine and blood testing.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Open-label prazosin treatment
Open-label administration of prazosin
干预措施: Prazosin Hydrochloride (Drug)
结局指标
主要结局
Retention
时间窗: 12 weeks
Mean and median weeks participants remained in the study between baseline and end of treatment at week 12
Acceptability of participation
时间窗: 16 weeks
Total score from a 7-item exit questionnaire each with 5 point scale responses assessing: likelihood of repeat participation, difficulty of participation, difficulty of attending study visits, difficulty of taking study medication, satisfaction with study team, likelihood of referral, overall satisfaction of participation
Recruitment
时间窗: Approximately 2 weeks
Proportion of potential participants referred to the study meeting inclusion/exclusion criteria and complete the baseline visit
Quantifying cannabis consumption
时间窗: 16 weeks
Regression comparison of semi-quantitative urine tetrahydrocannabinol (THC) metabolite and self-reported cannabis use by timeline follow back over the course of the study
次要结局
- Treatment outcome (exploratory)(16 weeks)
研究者
Garth Terry
Assistant Professor, School of Medicine
University of Washington