NCT05666856

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

Active, enrolled NA Last updated 9 August 2024

What this trial tests

NA trial testing Community Reinforcement And Family Training in Community Reinforcement And Family Training in 212 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

29 November 2022

Primary endpoint
4 May 2024

22 September 2024

Quick facts

Lead sponsor	We The Village, Inc.
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	212
Start date	29 November 2022
Primary completion	4 May 2024
Estimated completion	22 September 2024
Sites	1 location across United States

Drugs / interventions tested

• Community Reinforcement And Family Training
• We The Village Peer Community Forum

Conditions studied

• Community Reinforcement And Family Training — all drugs for Community Reinforcement And Family Training →
• Family Health — all drugs for Family Health →
• Substance-Related Disorders — all drugs for Substance-Related Disorders →

Sponsor

We The Village, Inc.

Who can join

19 and older, any sex, with Community Reinforcement And Family Training or Family Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.