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临床试验/CTRI/2022/01/039182
CTRI/2022/01/039182尚未招募不适用

Enhanced ASSIST-linked brief intervention and referral to treatment for illicit Drugs and alcohol use in prison population: a double-blind randomized clinical trial (HAMDARD)

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2022年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
376
试验地点
1
主要终点
2. Feasibility and acceptability of brief intervention for substance use disorders in prison population

研究概览

简要总结

Introduction:

A systematic review & meta-analysis foundthat the prevalence of drug use in prisons ranges from 10%-60% among men and30%-70% among women. Moreover, many prisoners would have been imprisonedbecause of their drug use (in countries where drug use has been criminalized,e.g., India). The drug-related deaths increased three to eight-fold in thefirst two weeks of discharge,6. Therefore substance use in prison poses asevere risk to public health and society. Indian prisons lack a systemicapproach to dealing with substance use disorders. An otherwise effectiveintervention, the ASSIST-linked enhanced SBIRT, could be tested in theresource-limited prison settings of India. If it is effective, it can addressthe treatment gap and reduce substance use and other substance-related complicationsin the prison population. A study of the predictors of response to the SBIRTshould help optimize the available resources. SBIRTcould also creates a windowof opportunity for the decriminalization of drug use by making treatmentavailable, accessible, acceptable, and affordable to those imprisoned for thepossession of small quantities of drugs.

Objectives:

To develop and test the enhanced-SBIRT for riskysubstance use.

To explore the barriers and facilitators of theintervention.

Methods:

The study will consist of formative,intervention, and post-intervention phases. The formative stage will havein-depth interviews and focus group discussions. The manually coded transcribeddata will generate the themes and sub-themes for developing the “enhancedâ€component of the SBIRT. The intervention phase will be a double-blind,individual-based, parallel-design RCT (n=188 in each arm after powercalculation). Results access may begin at 12 and 24 weeks after intervention.This phase is to determine the feasibility and preliminary efficacy of theintervention. Capability, Opportunity, Motivation-Behaviour change theoreticalframework will be used to understand the processes in the final phase of thepost-intervention process evaluation.

Expected outcome:

The newly developed enhanced-SBIRT should befeasible and acceptable to the Indian prison population. It will reduce theseverity, frequency of substance use, and will have a significant reduction inhigh-risk behaviour and overdose risk. The intervention will be tested at thestate and even at the national level.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASSIST score in the “moderate riskâ€.
  • If the participant scores within the moderate-risk range for two or more of the target drugs, the intervention will be focused on the highest-scoring substance or the substance that is of most concern to the participant.
  • Alcohol, in any case, receive the intervention.
  • Inmates who will remain in the prison for at least 6 months following intervention; for under-trial prisoners, it will be decided on the basis of the next date of the court hearing.

排除标准

  • Only tobacco use Unable to provide informed consent for cognitive impairment.
  • Not willing to participate in the intervention and for follow-up assessments.

结局指标

主要结局

2. Feasibility and acceptability of brief intervention for substance use disorders in prison population

时间窗: Third and Sixth months.

1. To develop the “enhanced†component of SBIRT

时间窗: Third and Sixth months.

3. Reduction in the ASSIST score by more or equal to 7 points in the intervention arm compared to the control arm.

时间窗: Third and Sixth months.

次要结局

  • 1. To identify the facilitators and barriers of the uptake of the intervention and to(modify the intervention accordingly.)

研究者

申办方类型
Government funding agency

研究点 (1)

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