A Tailored, Peer-delivered Intervention to Reduce Recurring Opioid Overdoses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Medication-Assisted Treatment Enrollment
研究概览
简要总结
This project will further develop and test the Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid Overdoses (TTIP-PRO), a promising, low-cost, intervention to facilitate entry into medication assisted treatment (MAT) for individuals experiencing a non-fatal opioid overdoses (OOD). A prior small-scale pilot/feasibility study of TTIP-PRO (NCT02282306) found that the participating patients and the Peer Interventionists were satisfied with their participation, the intervention was acceptable, and the system for generating patient-tailored intervention information performed well. The overall goal of the present study is to conduct a pilot randomized controlled trial of TTIP-PRO versus a control group. It is hypothesized that patients in the TTIP-PRO group will have more favorable drug-abuse-related outcomes than patients in the control group.
详细描述
This pilot study is a randomized controlled intent-to-treat (ITT) clinical trial. Approximately eighty eligible participants will be randomized in a 1:1 ratio to the control condition (Information and NARCAN® (naloxone) Nasal Spray kit) or to the experimental condition (TTIP-PRO in addition to the elements provided in the control condition). All participants will complete a follow-up phone call approximately 3-weeks post-randomization, during which process measures will be completed, and in-person visits at approximately 3, 6-, and 12-months following enrollment.
This is a single site study; all data will be collected at the University of Cincinnati. Approximately 80 participants will be randomized into this pilot efficacy trial. The hypotheses to be tested include that participants assigned to the TTIP-PRO intervention will: have a higher rate of enrollment in MAT, have a lower rate of recurring opioid overdose, and have greater reduction in illicit opioid use.
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
- 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
- 否
入选标准
- •Report having been treated for an OOD within the past 6 months
- •Age 18 years or older;
- •Scores "high risk" for heroin and/or non-medical use of prescription opioids on the National Institute on Drug Abuse modified Alcohol, Smoking and Substance Involvement Screening Test (NIDA-modified ASSIST) (i.e., ≥ 27)
- •Be able to understand the study, and having understood, provide written informed consent in English
- •Access to a phone (for TTIP-PRO intervention and phone follow-up)
- •Be willing to have their intervention audio recorded and rated if randomized to TTIP-PRO
- •Have an opioid-positive baseline/screening urine drug screen.
排除标准
- •In the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.)
- •Current engagement in addiction treatment
- •Residence more than 40 miles from the location of follow-up visits
- •Inability to provide sufficient contact information (must provide at least 2 reliable locators)
- •Prior participation in the current study.
研究组 & 干预措施
PTOEND
PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.
Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.
干预措施: naloxone nasal spray kit (Drug)
PTOEND
PTOEND: Personally-tailored opioid overdose prevention education and naloxone distribution.
Participants in this arm will be given a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment.
干预措施: Personally-tailored opioid overdose prevention education (information packet) (Behavioral)
PTOEND+PI
PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.
In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.
干预措施: Peer Intervention (Behavioral)
PTOEND+PI
PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.
In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.
干预措施: naloxone nasal spray kit (Drug)
PTOEND+PI
PTOEND+PI: Personally-tailored opioid overdose prevention education and naloxone distribution, plus Peer Intervention.
In addition to a NARCAN (naloxone) nasal spray kit and personally-tailored information packet about opioid overdose and treatment, participants randomized to this arm will also receive the experimental Peer Intervention.
干预措施: Personally-tailored opioid overdose prevention education (information packet) (Behavioral)
结局指标
主要结局
Medication-Assisted Treatment Enrollment
时间窗: 12 months
whether or not participant enrolled in medication-assisted treatment within the follow-up period
次要结局
- Opioid Overdose Experience(12 months)
- Change in Opioid Use (Timeline Follow-back)(at 12-month visit)
- Change in Opioid Use (Urine Drug Screen)(at 12-month visit)
研究者
Theresa Winhusen, PhD
Professor; Associate Vice Chair and Division Director of Addiction Sciences
University of Cincinnati