Cannabinoids for the Treatment of Anxiety Disorders: An 8-Week Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Rating Scale (HAM-A)
研究概览
简要总结
This proposed study aims to evaluate the efficacy of a daily oral cannabinoid oil preparation in treating symptoms of DSM-5 anxiety disorders, using a two-arm, 8-week randomized, placebo-controlled trial in adults aged 21-65 years. The study will also evaluate the relationship between inflammation, anxiety and cannabinoids using biological markers as well as examine the neuro-cognitive effects of cannabinoid treatment.
详细描述
The study will be a randomized, double-blind, placebo-controlled parallel design comparing the efficacy and safety of a flexibly dosed cannabinoid oil preparation versus matching placebo for the treatment of adults, aged 21 to 65 years with a primary Diagnostic and Statistical Manual 5 (DSM-5) anxiety disorder: Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD), or agoraphobia. A total 50 participants (n=25/cell) who meet the inclusion criteria will be randomized to receive 1 of 2 treatments in a 1:1 ratio: cannabinoid oil preparation or matching placebo, with the possibility of dose titration during this 8-week period. The outcomes of this research will make a significant contribution to enhance our current understanding of the effects of cannabis in anxiety disorders.
To be involved in this study, the study doctor will first check that the participant is qualified. This is called screening, and will involve a clinical assessment, physical exam and urine tests. This visit may take up to 3 hours to complete.
If the participant successfully completes screening the participant will start treatment in one of the two assigned treatment groups. Treatment is 8 weeks. Participants will come to the study clinic 6 times during the treatment phase of the study. Each visit will last 1 to 2 hours. Each visit will involve reporting any side effects that the participant may have experienced, completing questionnaires about mood and anxiety symptoms, sleep, overall functioning and alcohol and drug use. Participants will also be assessed by the study doctor. The first and last visits will also involve blood work and completing a number of tasks on the computer, which measure focus, attention and memory.
Each participant will be involved in the study for a maximum of 10 weeks. This includes the screening visit and follow-up visit.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients 21-65 years of age with a primary psychiatric diagnosis of either GAD, SAD, PD or agoraphobia as defined by DSM-5 criteria and a HAM-A score greater than or equal to
- •Physical exam and laboratory findings without clinically significant abnormalities. Screening bloodwork values for hematology and chemistry are to be Within Normal Limits.
- •Participants must agree to abstain from recreational cannabis use for the duration of the study.
- •Concomitant psychotropic medication use will be allowed provided that the dose has been stable for 8 weeks prior to randomization. (including antidepressants, anti-psychotics, benzodiazepines, and stimulants)
排除标准
- •Current recreational or medicinal use of cannabis within 4 weeks of study initiation.
- •Participants with a lifetime history of cannabis use disorder or other substance use disorders (except tobacco use disorder) will be excluded.
- •Participants with a lifetime history of daily cannabis use will be excluded.
- •Dose changes of concomitant medication will not be permitted during the study period.
- •Participants currently using medications that are CYP3A4, CYP2C19 or CYP2D6 inhibitors or inducers which includes but is not limited to: tricyclic antidepressants, topiramate, clobazam, amitriptyline, fentanyl, the related opioids sufentanil and alfentanil, codeine, oxycodone, macrolides, calcium channel blockers, cyclosporine, sildenafil, tadalafil, antihistamines, antiretrovirals, atorvastatin and simvastatin, warfarin and valproate or other anti-epileptics.
- •Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant.
- •Diagnosis of any of the following mental disorders as defined by the DSM-5: a lifetime history of schizophrenia or any other psychosis, mental retardation, organic medical disorders, bipolar disorder. Entry of patients with obsessive compulsive disorder or posttraumatic stress disorder will be permitted if the anxiety disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.
- •Major depression will be allowed if not severe (Montgomery Asberg Depression Rating Scale-MADRS28≥ 25). Patients with significant suicidal ideation (MADRS item 10 score > 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- •Participants with a family history of psychosis will be excluded.
- •Participants who have a history of adverse reactions to cannabis will be excluded.
- •Participants who have severe cardiovascular, immunological, liver, or kidney disease, arrhythmia or a history of arrhythmias will be excluded.
研究组 & 干预措施
Placebo Oil - Oral Preparation
MCT Oil
Dosing will start at 2 mls twice a day for one week and be titrated to 4 mls twice/daily for one week. At the end of Week 2, dose may be titrated to 6 mls twice a day ; then at the end of Week 4, dose may be titrated to 8 mls twice daily (a volume equivalent to the maximum of 800 mg/day total dose of High CBD).
The dose will be titrated in incremental volumes equivalent to 200 mg of active product (4 mls)/day/week if participants are tolerating their current dose, are experiencing no adverse events and have not fully responded so that they may potentially reach the volume equivalent to 800 mg/day/week by Week 4.
干预措施: Placebo Oil (Drug)
结局指标
主要结局
Hamilton Anxiety Rating Scale (HAM-A)
时间窗: Change from baseline to week 8
The 14-item HAM-A was developed to assess general anxiety symptoms in a clinical population and has proven sensitive to change with treatment. It is a clinician-rated measure and will be administered at each visit by a trained, blinded rater, using the Structured Interview Guide for the HAM-A. It has 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) are summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.
次要结局
- MINI-Plus: Mini International Neuropsychiatric Interview (MINI)(Change from baseline to week 8)
- World Health Organization Disability Assessment Scale (WHODAS 2.0)(Change from baseline to week 8)
- Obsessive Compulsive Inventory-Revised (OCI-R)(Change from baseline to week 8)
- PTSD Checklist (PCL-5)(Change from baseline to week 8)
- Neurocognitive tests(Change from baseline to week 8)
- Generalized Anxiety Disorder-7 (GAD-7)(Change from baseline to week 8)
- Liebowitz Social Anxiety Scale- Self Report (LSAS-SR)(Change from baseline to week 8)
- Insomnia Severity Index (ISI)(Change from baseline to week 8)
- DEQ - Drug Effects Questionnaire(Change from baseline to week 8)
- Inflammatory markers(Change from baseline to week 8)
- Clinical Global Impression - Severity (CGI-S)(Change from baseline to week 8)
- Clinical Global Impression - Improvement (CGI-I)(Change from baseline to week 8)
- Sheehan Disability Scale (SDS)(Change from baseline to week 8)
- Marijuana Craving Questionnaire(Change from baseline to week 8)
- The Columbia Suicide Severity Rating Scale,(Change from baseline to week 8)
- Panic and Agoraphobia Scale (PAS)(Change from baseline to week 8)
- Quick Inventory of Depressive Symptomology (QIDS)(Change from baseline to week 8)
- MADRS - Montgomery Asberg Depression Rating Scale(Change from baseline to week 8)
- CCCAB - Cannabinoid-induced Cognitive Consequences Assessment Battery(Change from baseline to week 8)