Cannabidiol in the Treatment of Opioid Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Proportion of participants with positive urine toxicology
研究概览
简要总结
The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of our project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD. This next phase is to determine whether CBD can serve as a potential adjunct treatment to reduce craving and anxiety in individuals with OUD maintained on opioid agonist therapy.
详细描述
In this Phase 2 study, the research team will conduct a double-blind (placebo-controlled) randomized controlled trial to evaluate whether 200mg and/or 400mg CBD (BSPG Laboratories) given twice daily (morning and evening), as compared to placebo, reduces cue-induced craving and anxiety in individuals with opioid use disorder who are maintained on methadone or buprenorphine. In addition to in-lab physiological and behavioral assessments of cue-induced craving and anxiety, the research team will also employ ecological momentary assessment to obtain real-world measures of symptoms including craving, anxiety, and mood.
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
- •An individual who meets all of the following criteria will be eligible for study participation:
- •Individuals between 18 and 65 years old
- •Ability to understand and give informed consent.
- •Current opioid use disorder (OUD) or OUD in remission while on maintenance therapy with OAT, as determined by DSM-5 with the M.I.N.I. interview (Mini-International Neuropsychiatric Interview).
- •Current opioid agonist maintenance treatment in an opioid treatment program with methadone or buprenorphine for at least 14 days prior to study participation. With the following more specific criteria for each of these two medications:
- •Current methadone maintenance treatment with a dose of ≥ 40mg/day, (maximum: 200mg/day), AND urinary toxicology positive for methadone and EDDP; OR
- •Current buprenorphine maintenance treatment with a dose of ≥ 8mg/day (maximum: 24mg/day), AND urinary toxicology positive for buprenorphine.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation:
- •Participants who are non-English speaking.
- •Psychiatric conditions under DSM-5 (examined with the MINI) that would make study participation unsafe or which would prevent adherence to study procedure; examples include: suicidal or homicidal ideation requiring immediate attention, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder).
- •Current diagnosis of a severe substance use disorder (except for opioid and nicotine/tobacco) in the past 3 months, based on the MINI interview, that would preclude safe participation in the study as determined by the study medical clinician.
- •Alcohol intoxication when arriving at the study site (i.e., positive alcohol breathalyzer / alcohol salivary strips / urine alcohol).
- •Signs of acute drug intoxication when arriving at the study site as determined by clinician assessment.
- •Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids); or any of the ingredients in the product (gelatin or sesame oil).
- •Showing signs of acute opioid withdrawal symptoms (as determined by the result of the Clinical Opiate Withdrawal Scale (COWS). A Score of ≥ 5 or as interpreted by the investigator will be considered a positive result for withdrawal symptoms).
- •Have a medical condition that would make study participation unsafe, which would make treatment compliance difficult, or would prevent adherence to study procedure. This includes, but is not limited to the following criteria:
- •History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: >4x the upper limit of normal (ULN) per laboratory criteria for AST or ALT, >1.5x ULN for bilirubin or <30mL/min/1.73m2 eGFR
- •QTc Frederica > 500ms
- •Participating in another pharmacotherapeutic trial in the past 3 months.
- •Participants who have used any medication, dietary supplements (and/or grapefruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (buproprion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study
- •For women: being pregnant (positive urine test for pregnancy) or breastfeeding.
- •Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. condom, spermicide, diaphragm).
- •Participants who have been court mandated to attend treatment centers.
研究组 & 干预措施
Methadone CBD
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
干预措施: Cannabidiol (CBD) 200mg (Drug)
Methadone CBD
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
干预措施: Cannabidiol (CBD) 400mg (Drug)
Methadone Placebo
Matching placebo.in first dosing period and CBD 400mg in second dosing period
干预措施: Placebo (Drug)
Methadone Placebo
Matching placebo.in first dosing period and CBD 400mg in second dosing period
干预措施: Cannabidiol (CBD) 400mg (Drug)
Buprenorphine CBD
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
干预措施: Cannabidiol (CBD) 200mg (Drug)
Buprenorphine CBD
CBD capsules (BSPG Laboratories) in two dosing periods for a total of 8 weeks.
干预措施: Cannabidiol (CBD) 400mg (Drug)
Buprenorphine Placebo
Matching placebo.in first dosing period and CBD 400mg in second dosing period
干预措施: Placebo (Drug)
Buprenorphine Placebo
Matching placebo.in first dosing period and CBD 400mg in second dosing period
干预措施: Cannabidiol (CBD) 400mg (Drug)
结局指标
主要结局
Proportion of participants with positive urine toxicology
时间窗: 4-weeks
Proportion of participants with positive urine toxicology for illicit opioid use at 4 weeks.
Change in Visual Analog Scale for Craving (VASC)
时间窗: Baseline and 4 weeks
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale ranges from 0-10, with higher scores indicating extreme cravings.
Change in Visual Analog Scale Anxiety (VASA)
时间窗: Baseline and 4-weeks
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Changes in anxiety from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) will be measured and compared. Total scale from 0-10, with higher score indicating extreme anxiety.
Systematic Assessment for Treatment Emergent Events (SAFTEE)
时间窗: weekly for 8 weeks
Systematic Assessment for Treatment Emergent Events (SAFTEE) is used to measure safety and tolerability. SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). Total score ranges 0 - 168, higher scores indicate a higher level of side effect burden.
次要结局
- Change in Heroin Craving Questionnaire Short Form (HCQ-SF-14)(4-weeks and 8-weeks)
- Change in Generalized Anxiety Disorder Scale (GAD-7)(4-weeks and 8-weeks)
- Duration of participant first illicit opioid abstinence(any time during study, 8 weeks)
- Change in Patient Health Questionnaire (PHQ-9)(4-weeks and 8-weeks)
- Change in Substance use other than opioids in blood(4-weeks and 8 weeks)
- Change in Visual Analog Scale for craving (VASC)(4-weeks and 8-weeks)
- Change in Visual Analog Scale Anxiety (VASA)(4-weeks and 8-weeks)
- Change in proportion of participants with positive urine toxicology(4 weeks and 8 weeks)
- Change in Oxygen level(baseline and 8-weeks)
- Change in The Digit Span Test subtest of the Wechsler Adult Intelligence Scale 4th edition(baseline and 8-weeks)
- Change in Change in dosage of opioid agonist treatment(baseline and 8 weeks)
- Positive and Negative Affect Schedule (PANAS-SF)(4-weeks and 8-weeks)
- Change in Heart rate(baseline and 8-weeks)
- Change in Blood pressure(baseline and 8-weeks)
- Change in Cue-induced salivary cortisol levels(4-weeks and 8-weeks)
- Sleep duration(up to 8-weeks)
- Change in Substance use other than opioids in urine(4-weeks and 8 weeks)
- Change in Insomnia Severity Index (ISI)(baseline and 8-weeks)
- Change in The Symptom Check List 90 (SCL-90)(baseline and 8-weeks)
- Change in Concentration of methadone or buprenorphine metabolites in urine(4-weeks and 8-weeks)
- Change in Concentration of methadone or buprenorphine metabolites in blood(4-weeks and 8-weeks)
- Number of participants remaining in treatment(up to 8 weeks)
- Number of positive urine toxicology(4 weeks)
- Number of positive blood toxicology(4 weeks)
- Change in Body Temperature(baseline and 8-weeks)
研究者
Yasmin Hurd
Professor
Icahn School of Medicine at Mount Sinai