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A Randomized Controlled Trial of Digital CBT to Treat Addiction: Digital RITch®CBT vs. Standard CBT

NCT05943171 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-26

No results posted yet for this study

Summary

Substance Use Disorders continue to increase across the United States with significant adverse effects resulting in more than $700 billion annually (NIDA, 2017) with high co-occurring rates of IPV. The negative consequences are devastating to families and society. This team has developed a digital, interactive platform, RITch®CBT for the convenience of participants' within their own home \& with out of session practice exercises. We propose to conduct a Phase I and II Study: UG3 (Phase I) and UH3 (Phase II) in collaboration with the FDA regarding ongoing feedback and regulatory processes. In Phase I, we propose a feasibility study, a randomized controlled trial to test the efficacy of RITch®CBT (n=20) among SUD-IPV diverse male clients entering addiction treatment comparing it to face to face 1:1 CBT (TAU, n=20). If efficacious, a Phase II (UH3, n=80) trial will be conducted to test the effectiveness of RITch®CBT among SUD-IPV compared to TAU (n=80) in reducing addiction and IPV.

Conditions

Interventions

DEVICE

Cognitive Behavioral Therapy

Digital treatment that deploys CBT.

BEHAVIORAL

Standard CBT

Human Administered Manualized CBT

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Rochester

    lead OTHER

Principal Investigators

  • James Filingeri · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-27
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05943171 on ClinicalTrials.gov