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临床试验/NCT04544124
NCT04544124已完成不适用

Expanding Capacity in Alberta to Deliver Contingency Patient Management in Outpatient Addiction Treatment: A Randomized Clinical Trial for Methamphetamine Use

University of Calgary4 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
4
主要终点
Differences in Treatment Retention from Baseline to Post-Intervention at Week 12

研究概览

简要总结

Methamphetamine misuse has become a growing concern in Alberta, creating a burden on the health care system. Further, individuals who use methamphetamine in Alberta exhibit significant difficulty remaining in treatment. These troubling patterns necessitate the provision of evidence-based practices (EBPs)-those grounded in empirical evidence-to ensure the best possible care and outcomes for those struggling with this addiction. Within the field of substance use (SU), contingency management (CM) is an extensively studied evidence-based treatment (EBT) for addictive disorders.

CM is an intervention that provides incentives to encourage positive behavioural change. Compared to standard care (treatment-as-usual (TAU)), CM has resulted in improvements in abstinence, attendance, adherence, retention, and quality of life. The efficacy of CM has largely been investigated in the context of reinforcing abstinence, though the literature suggests that CM which reinforces attendance may be as effective. Research from the US has examined the cost-effectiveness of CM and found that although CM costs more, it was associated with greater abstinence, treatment completion, and substance-absent urine compared to TAU. Despite the promising literature, the uptake of CM in Canada is limited making it difficult to understand whether this EBT is equally efficacious as compared to the US.

This study will implement and evaluate the efficacy of virtually delivered attendance-based CM in outpatient addiction treatment in Alberta. Participants (N=544) will be individuals seeking treatment for methamphetamine use (n=304) and individuals seeking treatment for substance use issues other than methamphetamine use (n=240). It is hypothesized that compared to participants in TAU, participants in CM will evidence: (1) greater retention, (2) greater attendance, (3) greater abstinence from methamphetamine and less methamphetamine use, (4) greater abstinence from other SU and less SU, and (5) greater improvement in quality of life over the intervention and follow-up periods. Exploratory aims include understanding how: outcomes differ based remote versus in-person delivery of CM; outcomes differ between participants who use methamphetamine and participants who use substances other than methamphetamine; the costs of CM differ from TAU; CM changes health service use.

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
None

盲法说明

Given incentivization will occur for attendance, it is not possible to blind conditions.

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

  • 18-years of age or older
  • Seeking treatment for methamphetamine use or substance use issues other than methamphetamine use
  • Reported methamphetamine use or substance use other than methamphetamine use within 3-months prior to study entry
  • Deemed appropriate for treatment-as-usual using Alberta Health Services clinical procedures
  • Willing to participate in the 12-week intervention in-person or virtually at least once weekly
  • Willing to participate in-person or virtually for a follow-up at 3, 6, and 12-months following the 12-week intervention period
  • Willing to complete questionnaires weekly during the 12-week intervention period and at each follow-up at 3, 6, and 12-months following the 12-week intervention period

排除标准

  • Past or current history of gambling problems
  • Imminent plans to enter an environment in which participation in this study is restricted (e.g., residential treatment, inpatient unit, detoxification, incarceration, house arrest).
  • Attended more than one treatment session since their intake, or screening date was more than one month following their first day of treatment at the Alberta Health Services clinic
  • No plans to attend weekly treatment at the Alberta Health Services clinic

结局指标

主要结局

Differences in Treatment Retention from Baseline to Post-Intervention at Week 12

时间窗: Baseline to Post-Intervention at Week 12.

The number of days between the first and last scheduled treatment session.

次要结局

  • Mean Number of Units Consumed of Other Quantifiable Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire(Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).)
  • Proportion of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12(Baseline to Post-Intervention at Week 12.)
  • Proportion of Days Abstinent from Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire(Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).)
  • Longest Consecutive Days Abstinent from Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire(Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).)
  • Proportion of Methamphetamine Abstinent Days Measured Using the Timeline Followback (TLFB) Questionnaire(Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).)
  • Longest Consecutive Days of Methamphetamine Use Measured Using the Timeline Followback (TLFB) Questionnaire(Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).)
  • Total Number of Units Consumed of Other Quantifiable Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire(Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).)
  • Longest Consecutive Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12(Baseline to Post-Intervention at Week 12.)
  • Total Number of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12(Baseline to Post-Intervention at Week 12.)
  • Longest Consecutive Days of Use of Other Licit and Illicit Substances Measured Using the Timeline Followback (TLFB) Questionnaire(Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).)
  • Largest Number of Units Consumed of Other Quantifiable Licit and Illicit Substances in One Day Measured Using the Timeline Followback (TLFB) Questionnaire(Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).)
  • Mean Number of Days Attended Scheduled Treatment from Baseline to Post-Intervention at Week 12(Baseline to Post-Intervention at Week 12.)
  • Longest Consecutive Days of Methamphetamine Abstinence Measured Using the Timeline Followback (TLFB) Questionnaire(Baseline to Post-Intervention Week 12 and from Week 12 to Week 15 (3-Month Follow-Up), Week 18 (6-Month Follow-Up), and Week 24 (12-Month Follow-Up).)
  • Longest Consecutive Days Absent from Scheduled Treatment from Baseline to Post-Intervention at Week 12(Baseline to Post-Intervention at Week 12.)

研究者

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

David Hodgins

Professor

University of Calgary

研究点 (4)

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