Clinical trial NCT03451344: A Electronic System to Improve Recovery Outcomes in Patients With Drug Use Disorder
Official title: A Community-based Addiction Rehabilitation Electronic System to Improve Recovery Outcomes in Patients With Drug Use Disorder: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use Disorders
Addiction, Drug
Keywords: Mobile Health
Illicit drug use
Rehabilitation
Community
China
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Relapse is very common in patients with illicit drug use disorder and contributes to a series of bad consequences that substantially impact patients' physical and social functions. Due to the limited existence of effective addiction treatment, the majority of patients with drug use disorder could not access help when needing. Mobile health (mHealth) offers a potential solution to improving recovery outcome for patients in community.

Objective: This paper is a protocol for a randomized controlled trial (RCT) of a smart phone application called community-based addiction rehabilitation electronic system (CAREs) . This interactive system consists of an APP for clients and a webpage for service providers, with the aim of teaching clients craving and emergency coping skills and helping service providers to improve work efficiency and effectiveness in community.

Methods: A randomized controlled trial(RCT) will be conducted. Sixty drug illicit users who are newly ordered to undergo community rehabilitation will be recruited from the community in Shanghai. Participants will be 1:1 randomly assigned to receive integrated community rehabilitation by using CAREs or only receiving routine community rehabilitation for 6 months. Corresponding anti-drug social workers will provide service and monitor participants' drug use behavior in accordance with the routine work-flow. Outcomes will be assessed at baseline and in the 6th month. The primary study outcome is the performance on illicit drug urine test which will be carried on regularly twice per week during the study period. Secondary study outcomes include days that participants interact with anti-drug social workers, and the decrease rate of addiction-related issues severity index.


Eligibility criteria: Inclusion Criteria:

* (1)Illicit drug users who are newly ordered to undergoing community-based rehabilitation will be recruited for the study.
* (2)Candidates are eligible to participated in if they are aged 20 - 50 years
* (3)Candidates are eligible to participated in if they are meeting the DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) criteria for substance dependence
* (4)Candidates are eligible to participated in if they are willing to comply with the relevant requirements of the study including using the mobile app
* (5)There is no limitation for Gender when recruiting participant.

Exclusion Criteria:

* (1)Illicit drug users who are not newly ordered to undergoing community-based rehabilitation.
* (2)Candidates' age is less than 20 or older than 50
* (3)Candidates does not meet the DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) criteria for substance dependence
* (4)Candidates are not able to use the mobile app

Primary outcomes:
measure: Drug urine test
timeFrame: Up to six months
Secondary outcomes:
measure: Interacting with anti-drug social workers
timeFrame: Up to six months
measure: The decrease rate of addiction-related issues severity index
timeFrame: Up to six months
measure: Longest duration of sustained abstinence
timeFrame: Up to six months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Haifeng Jiang
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Haifeng Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
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citation: Xu X, Chen S, Chen J, Chen Z, Fu L, Song D, Zhao M, Jiang H. Feasibility and Preliminary Efficacy of a Community-Based Addiction Rehabilitation Electronic System in Substance Use Disorder: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Apr 16;9(4):e21087. doi: 10.2196/21087.
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