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Drug Use DisordersNCT03451344

A Electronic System to Improve Recovery Outcomes in Patients With Drug Use Disorder

A study testing Integrated rehabilitation group and Community-based rehabilitation group in people with Drug Use Disorders and Addiction, Drug, run by Shanghai Mental Health Center at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Drug Use Disorders, Addiction, Drug
What is being tested?
Integrated rehabilitation group and Community-based rehabilitation group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Dec 2018to 1 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • (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.

Who cannot join

  • (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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Haifeng Jiang

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

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

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.

Being tested
Integrated rehabilitation group, Community-based rehabilitation group
Keywords
Mobile Health, Illicit drug use, Rehabilitation, Community, China
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated rehabilitation groupOther

    Participant in integrated rehabilitation group needs to visit their corresponding social worker and accept illicit drug test every two months. Social worker will help their corresponding client to apply for social benefits accordingly, and provide counseling irregularly if necessary. The integrated rehabilitation group received the standardized community-based rehabilitation described above and simultaneously received a 6-month integrated rehabilitation based on CAREs (Community-based Addiction Rehabilitation Electronic System).CAREs was developed by the department of addiction research in Shanghai Mental Health Center(SMHC), with functions including education, support, psychological intervention and other functions.

  • Community-based rehabilitation groupOther

    Participant in community-based rehabilitation group needs to visit their corresponding social worker for six months and accept illicit drug test every two months. Social worker will help their corresponding client to apply for social benefits accordingly, and provide counseling irregularly if necessary.

Study groups in NCT03451344
Study groupRoleWhat they receive
Integrated rehabilitation groupExperimentalParticipants will receive the standardized community-based rehabilitation and simultaneously receive a 6-month integrated rehabilitation based on the Community-based Addiction Rehabilitation Electronic System.
Receives: Other: Integrated rehabilitation group
Community-based rehabilitation groupActive comparatorParticipants will receive the standardized community-based rehabilitation.
Receives: Other: Community-based rehabilitation group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug urine test

    The results of drug urine tests will be examined in overall percentage of drug positive samples. Overall percentage of drug positive samples= the number of positive urine tests results / the number of total urine tests (Subject who does not submit urine samples on time during the intervention period or refuses to submit samples even if he/she is present at the site will be considered as having a positive urine test result).

    Measured: Up to six months

Secondary outcomes (3)

  1. Interacting with anti-drug social workers

    Interaction with anti-drug social workers: The days that participants interact with their corresponding social workers will be collected during the study period. Any phone call, SMS, face-to-face meeting, or communication via CAREs will be considered as interaction happening.

    Measured: Up to six months

  2. The decrease rate of addiction-related issues severity index

    The Chinese translation of the Addiction Severity Index (ASI) that has good reliability and validity in China will be used to assess the severity of addiction at enrollment and 6 months after enrollment. The descent rate will be counted via dividing the minus value between baseline score and 6-month score by baseline score.

    Measured: Up to six months

  3. Longest duration of sustained abstinence

    Longest duration of sustained abstinence will be measured by drug urine tests and will be reported in weeks(the most consecutive weeks of drug negative samples).

    Measured: Up to six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2018
  2. Study start1 Dec 2018
  3. Primary completion1 Jun 2019
  4. Study completion1 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03451344
Sponsor's protocol ID
HFJiang
Status last verified
Sep 2021
First submitted
10 Jan 2018
Last updated
20 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Free C, Phillips G, Watson L, Galli L, Felix L, Edwards P, Patel V, Haines A. The effectiveness of mobile-health technologies to improve health care service delivery processes: a systematic review and meta-analysis. PLoS Med. 2013;10(1):e1001363. doi: 10.1371/journal.pmed.1001363. Epub 2013 Jan 15.

    PubMed 23458994

  • Ingersoll K, Dillingham R, Reynolds G, Hettema J, Freeman J, Hosseinbor S, Winstead-Derlega C. Development of a personalized bidirectional text messaging tool for HIV adherence assessment and intervention among substance abusers. J Subst Abuse Treat. 2014 Jan;46(1):66-73. doi: 10.1016/j.jsat.2013.08.002. Epub 2013 Sep 9.

    PubMed 24029625

  • Mason M, Ola B, Zaharakis N, Zhang J. Text messaging interventions for adolescent and young adult substance use: a meta-analysis. Prev Sci. 2015 Feb;16(2):181-8. doi: 10.1007/s11121-014-0498-7.

    PubMed 24930386

  • Gustafson DH, McTavish FM, Chih MY, Atwood AK, Johnson RA, Boyle MG, Levy MS, Driscoll H, Chisholm SM, Dillenburg L, Isham A, Shah D. A smartphone application to support recovery from alcoholism: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):566-72. doi: 10.1001/jamapsychiatry.2013.4642.

    PubMed 24671165

  • Leonhard C, Mulvey K, Gastfriend DR, Shwartz M. The Addiction Severity Index: a field study of internal consistency and validity. J Subst Abuse Treat. 2000 Mar;18(2):129-35. doi: 10.1016/s0740-5472(99)00025-2.

    PubMed 10716096

  • 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.

    PubMed 33861211

  • Wang Z, Chen S, Chen J, Xu C, Chen Z, Zhuang W, Li X, Zhao M, Haifeng J. A Community-Based Addiction Rehabilitation Electronic System to Improve Treatment Outcomes in Drug Abusers: Protocol for a Randomized Controlled Trial. Front Psychiatry. 2018 Nov 6;9:556. doi: 10.3389/fpsyt.2018.00556. eCollection 2018.

    PubMed 30459653

Questions about this trial

What is this clinical trial studying?

A study testing Integrated rehabilitation group and Community-based rehabilitation group in people with Drug Use Disorders and Addiction, Drug, run by Shanghai Mental Health Center at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug urine test (time frame: Up to six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03451344, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.

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