Scalable Digital Delivery of Evidence-based Training for Family to Maximize Treatment Admission Rates of Opioid Use Disorder in Loved Ones

Status unconfirmed · Not applicable

Conditions studied: Community Reinforcement And Family Training, Family Health, Substance-Related Disorders

In brief

The United States is in the midst of an opioid crisis. Over-prescription of opioid analgesic pain relievers contributed to a rapid escalation of use and misuse of these substances across the country. In 2016, more than 2.6 million Americans were diagnosed with opioid use disorder (OUD) and more than 42,000 have died of overdose involving opioids. This death rate is more than any year on record and has quadrupled since 1999 (1,2). Leveraging the potential of available data bases and health IT technologies may help to combat opioid crisis by targeting various aspects of the problem ranging from the prevention of opioid misuse to OUD treatment. NIH through NIDA solicits the research and development of data-driven solutions and services that focus on issues related to opioid use prevention, opioid use, opioid overdose prevention or OUD treatment. In this project, We The Village, Inc. will address a need to prepare Concerned Significant Others (CSOs) to best use their influence over the trajectory of a loved one's OUD. CSOs are motivated to help, make majority of treatment decisions and payments and have influence over treatment entry and thus, impact the trajectory of an OUD. The goal of the project is to establish the technical efficacy and commercial viability of CRAFT-A at scale by conducting the fully powered randomized controlled trial (RCT) comparing two online interventions: CRAFT-A (hereinafter referred to as CRAFT or digital CRAFT) and PEER support (the original comparison group). Based on Phase I findings, the team anticipates the CRAFT condition will achieve better outcomes than the PEER condition in a) treatment entry and retention, b) Concerned Significant Others' (CSO) health and wellbeing, c) CSO-IP relationship, and d) CRAFT knowledge.

Key facts

Study ID: NCT05666856
Run by: We The Village, Inc.
People needed: 212
Starts: 2022-11-29
Expected to finish: 2024-09-22
Last updated by the study team: 2024-08-09

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Is a concerned significant other (CSO) of a loved one with an OUP
Be 19 years or older
No substance use disorder
Has concern about the opioid use of a loved one (IP)
Plans to be in close contact (phone/face-to-face) with the IP (i.e., 12 days out of 30)
The IP is not currently receiving treatment, or is in treatment, but the CSO perceives they may benefit from additional treatment (e.g., in residential treatment, but will need to enter outpatient treatment upon discharge or receiving drug free outpatient but not progressing, so may benefit from MAT).

You may not qualify if…

Does not agree to all procedures and sign the consent form
Is not English-speaking
Is not able to understand the consent form
Pass a multiple-choice consent quiz (i.e., 100% correct responses) that tests the participant's comprehension of basic elements of informed consent and the requirements of the protocol administered by the research team over the phone.
Participants will be given up to three opportunities to pass the consent quiz
Does not have personal access to a smart phone with data or a computer with internet to be able to access the digital platform for the study conditions, quizzes, questionnaires, and follow-up communication
Reports that they have a drug abuse problem or a history of drug abuse or dependence and that they have not been in recovery for at least 2 years
Resides outside the United States
Participated in previous We The Village pilot study

Where it is running

We The Village, Inc. — New York, New York, United States

Full record on ClinicalTrials.gov

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