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临床试验/NCT05776823
NCT05776823已完成不适用

Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorder

University of Arkansas2 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2023年5月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
267
试验地点
2
主要终点
Retention

研究概览

简要总结

The purpose of this study is to investigate the impact of a pharmacist-led intervention to expand access to medications for opioid use disorder (MOUD) on racial/ethnic differences in opioid-related overdose among individuals diagnosed with opioid use disorder (OUD) currently incarcerated in a carceral setting. In this study, participants will be screened for opioid use, trained to administer Narcan nasal spray, receive motivational counseling and referral to treatment post-release from a carceral setting (a Re-Entry program) into the community.

详细描述

The main objectives of this study are:

  1. To increase understanding of racial/ethnic differences in the prevalence of OUD.
  2. To test if a pharmacist-led intervention is more effective than a substance use counselor (lay person) in increasing knowledge and confidence among different racial/ethnic groups related to administering Narcan nasal spray in an opioid overdose situation.
  3. To test if a pharmacist-delivered an evidence-based intervention, q brief intervention and referral to treatment (BIRT) versus standard medication counseling (SMC) is more effective in increasing access to MOUD.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Narcan Training:
  • a Re-Entry program participant 7-14 days from release from carceral setting
  • provide collateral contact information for ≥2 persons (to ensure consistent contact/follow up)
  • have a reliable landline or mobile phone to be contacted by pharmacist
  • plan to remain in the Little Rock area for at least 6 months
  • able to read and write English
  • able to provide informed consent
  • possesses manual dexterity; physical ability to roll a person onto her/his/their back and side
  • have no allergy to naloxone hydrochloride (active ingredient in Narcan nasal spray)-
  • identified on the RODS screener as positive for OUD.
  • a Re-Entry program participant 7-14 days from release from the carceral setting
  • provide contact information for ≥2 persons (to ensure consistent contact/follow -up)
  • have a reliable landline or mobile phone to be contacted by pharmacist
  • plan to remain in the Little Rock area for at least 6 months
  • able to read and write English; able to provide informed consent
  • identified with OUD.

排除标准

  • Narcan training:
  • not a RE-entry program participant
  • identified substance use disorders other than OUD
  • not a RE-entry program participant
  • identified substance use disorders other than OUD

研究组 & 干预措施

Pharmacist Narcan Training

Experimental

Pharmacist-led intervention

干预措施: Pharmacist Narcan Training (Behavioral)

Substance Use Counselor Narcan Training

Active Comparator

Non-clinician intervention

干预措施: Substance Use Counselor Narcan Training (Behavioral)

Brief Intervention and Referral to Treatment (BIRT)

Experimental

BIRT intervention

干预措施: BIRT (Behavioral)

Standard Medication Counseling (SMC)

Active Comparator

SMC intervention

干预措施: SMC (Behavioral)

结局指标

主要结局

Retention

时间窗: at month 6

Participants, regardless of treatment arm, will receive follow-up telephone interviews at 6 months post-release from the carceral setting into the community. Interviews will address the primary question whether MOUD treatment was initiated and maintained.

Opioid overdose training

时间窗: at month 6

Participants' knowledge about opioid overdose and confidence to recognize and respond to opioid overdose situations as a function of the trainer. Participants will complete a brief validated survey, the adapted Perceived Competence Scale. The questions on the survey are rated on a 7-point scale and participants indicate how true four statements are about their ability to recognize and respond to overdoses: the scale, 1 (not at all true) to 7 (very true).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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