跳至主要内容
临床试验/NCT06033599
NCT06033599招募中3 期

Motivational Interviewing (MI) and Mindfulness-Oriented Recovery Enhancement (MORE) for Tobacco Dependence and Other Drug Use in Methadone Treatment

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2023年9月5日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
招募中
入组人数
420
试验地点
2
主要终点
Days of Drug Use

研究概览

简要总结

The purpose of this study is to 1) examine barriers and facilitators to implementation of MI and MORE for polysubstance use and evaluate strategies for optimizing training, fidelity, and clinic uptake, and 2) evaluate patient outcomes related to the effectiveness of MORE decreasing opioid, tobacco, and other drug use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, 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

  • •English-speaking
  • •Currently on methadone; and 4) currently smoke cigarettes.

排除标准

  • •Severe cognitive impairment (score >23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)
  • •Suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)
  • •Inability to attend or fully participate in intervention sessions or assessments
  • •Previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33
  • •Currently taking smoking cessation pharmacotherapy or participating in smoking cessation counseling
  • •Any contraindications for NRT
  • •Currently or soon planning to be pregnant or breastfeeding.

研究组 & 干预措施

MORE and No MI

Experimental

干预措施: MORE and No MI and NRT (Other)

MORE and MI

Experimental

干预措施: MORE and MI and NRT (Other)

Support Group and MI

Active Comparator

干预措施: Support Group and MI and NRT (Other)

Support Group and No MI

Active Comparator

干预措施: Support Group and No MI and NRT (Other)

结局指标

主要结局

Days of Drug Use

时间窗: Baseline through 52 weeks.

Number of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.

Days of Tobacco Use

时间窗: Baseline through 52 weeks.

Number of days of tobacco use as measured by self-reported days of use and biochemically verified use via expired carbon monoxide.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nina A. Cooperman, Psy. D.

Associate Professor

Rutgers, The State University of New Jersey

研究点 (2)

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