A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone Through Community Pharmacies for Their Stable Methadone Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Recruitment Rate
研究概览
简要总结
The overarching goal of this pilot study is to explore the feasibility, acceptability, and patient/provider satisfaction of pharmacy-based administration and dispensing of methadone for opioid use disorder. The results gained will inform the development of a future multisite randomized clinical trial.
详细描述
The study will use a non-randomized, prospective, single group design. Twenty long-term, clinically-stable methadone maintenance treatment (MMT) patients who receive between 6- and 13-days methadone take-home doses will be enrolled in the study where their methadone take-home administration and dispensing will be transferred to a community pharmacy for 3 months. Participants will also complete three follow-up assessments at 1-month, 2-months, and 3-months after the baseline visit to collect clinical and safety information since the previous assessment. Primary outcomes will be focused on feasibility measures (recruitment, accessibility to methadone treatment, substance use, medication call back success, and retention in treatment). Secondary outcomes will be focused on self-reported satisfaction measures from MMT providers (e.g., physician, physician assistant, nurse, and counselor) pharmacists, and patient participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient aged 18 or older receiving methadone treatment at Morse Clinic in Raleigh or Zebulon, NC.
- •Able to provide informed written consent to participate in the pilot study.
- •Receiving a stable methadone dose between 5 mg and 160 mg.
- •Having all negative drug tests (except for prescribed methadone and ethanol) at the OTP for the past 12 months.
- •No missed call-backs in the past 12 months.
- •No signs/symptoms of a co-occurring major mental illness (i.e., thought disorder, thoughts of harm to self or others, delusions or hallucinations, cognitive impairment compromising informed consent to study procedures and requirements).
- •Meeting the federal and state regulations for eligibility to receive between 6- and 13-days of take-home methadone and receiving this level of take-home doses at the time of study enrollment.
- •If female, using adequate birth control methods.
排除标准
- •Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
- •Have chronic pain requiring ongoing pain management with opioid analgesics.
- •Prisoner status or pending legal action that could prevent participation in study activities
- •Legal order for treatment (e.g., parole, probation, or pre-trial)
- •Pregnant or breastfeeding at the time of screening.
研究组 & 干预措施
Pharmacy-based methadone treatment
Participants will have their usual methadone dose administered and dispensed at a participating pharmacy. All other methadone services including counseling, drug testing, and medical services will be delivered as usual at the Methadone Program.
干预措施: Pharmacy-based methadone administration and dispensing (Drug)
结局指标
主要结局
Recruitment Rate
时间窗: 3 months
The recruitment rate will be assessed on a monthly basis (e.g, Month 1, 2 and 3) until the enrollment target is reached. The recruitment rate is operationalized as the total number of participants consented in one month.
Treatment Adherence
时间窗: Up to 3 months per participant
Adherence to pharmacy-based methadone treatment will be defined as the percentage of methadone take-home doses dispensed at the pharmacy out of the total number of take home doses prescribed.
Treatment Retention
时间窗: Up to 3 months per participant
Treatment retention will be determined by the percentage of participants who remain in treatment at the pharmacy during the 3-month follow-up phase.
Opioid and Other Substance Use
时间窗: Up to 3 months per participant
The percentage of positive urine drug screens over the study duration will be examined.
次要结局
- Treatment Satisfaction(Over 3 months of treatment)
- Adverse Events(Up to 3 months per participant)
- Percentage of Participants With Methadone Call Backs With Evidence of Tampering.(3 months)