The Heroes Circle Opioid Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Change in methadone dose
研究概览
简要总结
The purpose of this proposed pilot study is to extend the KKC Heroes Circle program to people with opioid use disorder (OUD) who are currently enrolled in methadone maintenance treatment (MMT) and who wish to learn these techniques to reduce their behavioral and physiological dependence on medication.
The goal is to engage these MMT patients in a complementary (non-pharmacological) therapeutic activity that may improve their self-efficacy and personal control, reduce the impact of stressors and chronic pain, drug craving, affective and physical function, and lower reliance on pharmacological interventions.
详细描述
Overall, this project will take approximately 1 year to complete, and will be divided into three phases (each about three months long).
Phase 1: The investigators will identify and consent 10 patients, regardless of age, sex, or race/ethnicity, enrolled at the Tolan Park Research Clinic who endorse a desire to lower their daily methadone maintenance dose but have been unable to do so.
Each participant will complete a 12-week protocol. There will be twice weekly visits (each ≈30 min total for all procedures) by the trained adult Kids Kicking Cancer (KKC) martial artists. Prior to receiving his/her methadone dose, the martial artist and patient will meet in a private area to promote attention and focus on the intervention, and for measurement of biomarker data. At baseline and during weeks 4, 8 and 12, the investigators will obtain pre- and post-session saliva samples (collected with a Salivette held under the tongue 3 min) to measure two stress biomarkers. The investigators will also measure heart rate and blood pressure. Each participant will receive 20 minutes of individual instruction in a therapeutic approach to lower their stress and life challenges. Each visit will include certain martial arts rituals, including the KKC "Power, Peace, Purpose"™ mantra, and Breath Brake®, introduced by videotapes made by the "heroes" (children). Other components of the intervention session, e.g. movement exercises and mental imagery, will be tailored to the patient, always ensuring that any physical maneuver is safe for that individual. They will also receive audio meditations for smart phones or, if unavailable, loaded onto mp3 players to practice the meditations.
At the beginning and end of each visit by the martial artist, the participant will use Visual Analog Scales (VAS, 0-10 range) to rate his/her momentary level of "pain", "drug craving", "anxiety", "anger", and "depression"; and he/she will complete the short form of the Positive and Negative Affect Schedule. Each meeting will be supplemented by phone calls 3 times a week from the martial artist to each patient to supply support.
Data collection measurements: Beck Depression Inventory-II, State-Trait Anxiety Inventory, Perceived Stress Scale, Difficulties with Emotion Regulation Scale, Coping Orientation to Problems Experienced (Brief-COPE), Alcohol and Drug Use Self-Efficacy Scale, Distress Tolerance Scale, Breath-hold Endurance task, Brief Pain Inventory, Medical Outcomes Study Short Form, a computerized measure of attentional function, the Attentional Network Task, also known as Flanker Task.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of Opioid Use Disorder
- •Stable daily methadone dose for at least one month prior to enrollment
- •Desire to reduce the daily methadone dose at least 20%.
排除标准
- •Pregnant (urine test) or lactating (self-report)
- •Current severe Axis I psychiatric disorder, e.g. psychosis, bipolar disorder
- •Suicidal ideation/attempt during the past year
- •Medical contraindications to the proposed therapeutic program, in the opinion of the clinic physician.
结局指标
主要结局
Change in methadone dose
时间窗: Once at baseline and twice-weekly over a 12-week period.
Extracted from the patient's medical record
Drug-free urine test results (<300 ng/ml) for opioids, cocaine, benzodiazepines, and barbiturates (<300 ng/ml), and cannabinoids (<50 ng/ml).
时间窗: Once at baseline and twice-weekly over a 12-week period.
Extracted from the patient's medical record
次要结局
- Change in self-report of pain, drug craving, anxiety, anger and depression(Beginning and end of each visit by the martial artist (pre/post effects); Once at baseline and twice-weekly over a 12-week period.)
- Change in self-report of the following feelings and emotions: Afraid, Ashamed, Hostile, Nervous and Upset(Beginning and end of each visit by the martial artist (pre/post effects); Once at baseline and twice-weekly over a 12-week period.)
- Change in heart rate biomarker (beats per minute (bpm)(Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections.)
- Change in blood pressure (Systolic and Diastolic mmHg) biomarker(Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections.)
- Change in saliva cortisol biomarkers(Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections.)
- Change in C-reactive protein biomarkers(Once at baseline and once during week 4, week 8, and week 12 over the 12-week period for a total of 4 collections.)
- Percentage of patients who reduce methadone dose at least 20 percent(Once at baseline and twice-weekly over a 12-week period.)
研究者
Mark Greenwald, PhD
Professor
Wayne State University