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临床试验/NCT04464421
NCT04464421已完成不适用

Pilot Test of Contingency Management and Brief Motivational Interviewing + Substance Free Activity Session Interventions + Mindfulness-Based Adherence Promotion

Karen Derefinko, PhD1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年8月17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
发起方
入组人数
48
试验地点
1
主要终点
Treatment Adherence

研究概览

简要总结

The current study piloted two psychosocial interventions developed to increase buprenorphine-naloxone adherence in individuals with opioid use disorder (OUD). Participants were randomized to receive either contingency management (CM) or a brief substance free activities session plus mindfulness (BSM) cognitive-behavioral intervention. Participants were 48 newly presenting patients from an OUD treatment clinic. The primary outcome was medication adherence, as measured by buprenorphine metabolite in urine and presence at 2 or more of 4 possible physician visits.

详细描述

We engaged with referred OUD patients at the time of their initial visit to the clinic. Interested patients were informed about the study in a private room, and if eligible, were consented and randomized to condition. Randomization occurred in blocks of 4. At the next physician visit, participants engaged in their first intervention activities (either CM or BSM). This was repeated for the following 3 physician visits.

CM. Contingency Management (CM). The CM intervention provided participants with a gift card at each of the first 4 follow up physician visits to the clinic where the participant's urine showed evidence of buprenorphine use. The strategy for CM rewards was based upon Petry's "fishbowl" draw, where variable values of gift cards were available for draw at each positive buprenorphine urine toxicology result. For the current study, which was conducted when COVID safety requirements were still high, a computerized "picker wheel" was used rather than an actual fishbowl to reduce possible viral transmission. Participants watched the wheel spin and told the interventionist when to stop the spin, at which time the value of the gift card was displayed. The picker wheel was programmed to include a 60% chance of a $25 gift card, a 20% chance of a $50 gift card, and a 20% chance of a $100 gift card. The average (expected) value of gift cards at this rate was $45 (or $180 total across 16 weeks, well below the typical range used in similar work).

BSM. Brief Motivational Interviewing plus Substance Free Activities Session plus Mindfulness (BSM). The BSM intervention included the following topics: (1) Short and Long-Term Goals: Identifying goals (e.g., What are your goals for this month…for the next 5 years?), requirements needed to achieve these goals (e.g., What would you need to do to achieve those goals?) and the potential role of relapse in jeopardizing these goals; (2) Personalized Feedback on Recent Time Allocation: (e.g., time spent with family, work, education/hobbies/creative activities, exercise/time in nature/self-care, watching tv/surfing the internet, religious or spiritual activities, recovery and nonrecovery activities; along with open ended questions asking about the extent to which their recent time allocation is consistent with their goals and values; (3) Episodic Future Thinking: An experiential intervention that prompts individuals to describe personal, emotional, and situational details of a valued future outcome that they desire; (4) Substance Free Activities: Based upon named hobbies and interests, participants were offered a personalized list of locally available substance-free activities developed by the interventionist; (5) Stop Observe Breathe Expand Respond (SOBER) Breathing Space: This exercise is intended to bring awareness to one's experiences without judgment. This technique includes the following steps: Stop or Slow down. Observe what is happening. Bring attention to Breathing. Expand awareness to the whole body. Respond mindfully, with awareness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • •Present for an intake appointment at study site for treatment of opioid use disorder.
  • •Eligible for receipt of buprenorphine-naloxone treatment (e.g. Suboxone, Bunavil, Zubsolv) as determined by clinic physicians
  • •18 years or older
  • •Willing to be randomized to one of the two intervention arms
  • •Ability to comprehend consent and intervention materials (approximately 8th-grade level).

排除标准

  • 未提供

研究组 & 干预措施

Contingency management (CM)

Experimental

Participants received incentives for urine toxicology with a positive result for Buprenorphine metabolites at each of the first four visits after initiation of Buprenorphine-Naloxone.

干预措施: Contingency Management (CM) (Behavioral)

BSM

Experimental

BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants had one-on-one behavioral intervention sessions at each of the first four visits after initiation of Buprenorphine-Naloxone.

干预措施: Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM) (Behavioral)

结局指标

主要结局

Treatment Adherence

时间窗: Through study completion, an average of 4 months

Defined as no negative buprenorphine urine tests and attendance of at least two visits.

次要结局

未报告次要终点

研究者

发起方
Karen Derefinko, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karen Derefinko, PhD

Associate Professor

University of Tennessee

研究点 (1)

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