Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) for Opioid Use Disorder
试验速览
- 阶段
- 2 期
- 入组人数
- 190
- 试验地点
- 4
- 主要终点
- 6-month buprenorphine maintenance treatment (BMT) retention
研究概览
简要总结
Opioid Use Disorders (OUD) cause significant burden to individuals, families, and the society. Our product - Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) - offers a cost-saving, home-based, user-friendly brain stimulation system that increased 6-month treatment retention of OUDs in a pilot study; and also, acutely reduced opioid withdrawal severity and negative affect during induction into opioid maintenance therapy. This study will establish its effectiveness in a broad category of OUD subjects at different stages of OUD care continuum.
详细描述
Evon Medics proposes to evaluate the effectiveness of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT), as an alternative strategy for relapse prevention in patients with Opioid Use (OUD) and other substance use disorders (SUD). This treatment leverages the overlap in brain regions that process smell and mediate decision making. The CBOT is portable and can be used at home. This clinical trial is being conducted to demonstrate its utility for home application by nontreatment seeking and treatment-seeking OUD populations, to engage in long-term, successful opioid recovery.
Key objectives of this project are to: (1) establish the effectiveness of CBOT for improved retention and relapse prevention in a large sample of OUD subjects; (2) establish its effectiveness for acute reduction of withdrawal severity and negative affect early in recovery; and (3) evaluate its safety, user-friendliness and acceptability. Accomplishment of these goals would lead to larger clinical trials for OUD and wider applications of CBOT in other addictive disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18- 70years
- •Diagnosis of current moderate or severe OUD in the past 6 months, including the past one month
- •Willing to receive study interventions and buprenorphine during the study
- •Do not meet criteria for current moderate or severe use of other substance use disorders (except nicotine use disorder)
- •Diagnosis of Major Depressive Disorder, Anxiety disorders, and Post-traumatic Stress disorders will be included as long as the symptoms are stable, no suicidal ideas or plans and there are no recent changes in treatment of these conditions in the last 6 weeks prior to enrollment
- •No intranasal disease
- •Willing to participate by signing the informed consent form and
- •Have a place to stay when receiving the intervention.
排除标准
- •Any significant neurologic disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy or seizures
- •Mental retardation
- •Schizophrenia or bipolar disorders
- •Experiencing current suicide ideas or plans
- •Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, and liver cirrhosis, as determined by site PI
- •History of severe traumatic nose injury that affects ability to smell, as determined by site PI
- •Allergies or intolerance to aromas from plant essential oils (e.g. orange and lemon)
- •Breastfeeding or Pregnancy test positive.
- •On parole or probation mandated to receive treatment for OUD.
研究组 & 干预措施
CBOT + TAU
CBOT consists of 40 cycles of olfactory stimulation and OFC training tasks, lasting ~45 minutes, once daily over 3 months. Treatment-as-usual (TAU) is standard dosing of buprenorphine (BUP) to a median dose of 24 mg (range 16-32 mg).
干预措施: CBOT + TAU (Drug)
Sham + TAU
Sham is a CBOT device that uses artificially-scented compressed room air instead of olfactory stimulants and has no OFC cognitive tasks. Similar to the CBOT, sham will be used daily for 45 minutes. TAU is standard dosing of buprenorphine (BUP) to a median dose of 24 mg (range 16-32 mg).
干预措施: Sham + TAU (Drug)
结局指标
主要结局
6-month buprenorphine maintenance treatment (BMT) retention
时间窗: 36 weeks after baseline
6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
Change from Screening in Opioid Craving Scale (OCS) at Week 12 severity rating measures over 1 month
时间窗: Screening visit to Week 12
he Opioid Craving Scale, a modification of the Cocaine Craving Scale was used to measure opioid craving.
Change from Screening in Opioid Craving Scale (OCS) at Week 24 severity rating measures over 1 month
时间窗: Screening visit to Week 24
he Opioid Craving Scale, a modification of the Cocaine Craving Scale was used to measure opioid craving.
Change from Screening in negative affect severity in the PANAS
时间窗: Screening visit to Week 24
The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.
Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at week
时间窗: Screening to Week 12 Treatment
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely), and takes less than 10 minutes to complete.
Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at Week 24
时间窗: Screening to Week 24
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely), and takes less than 10 minutes to complete.
次要结局
- Pre-Intervention changes in SOWS from Screening at Week 2(Screening visit to Week 2)
- Post-Intervention changes in PANAS negative affect from Week 12 at Week 13(Week 12 to Week 13)
- Opioid Relapse(Screening visit to Week 12)
- Post-Intervention changes in SOWS from Week 12 at Week 13(Week 12 to Week 13)
- Pre-Intervention changes in OCS from Screening to Week 2(Screening visit to Week 2)
- Post-Intervention changes in OCS from Week 12 to Week 13(Week 12 to Week 13)
- Pre-Intervention changes in PANAS negative affect from Screening visit to Week 2(Screening visit to Week 2)
研究者
Evaristus Awele Nwulia
Chief Scientific Officer
Evon Medics LLC