NCT05943171 A Randomized Controlled Trial of Digital CBT to Treat Addiction: Digital RITch®CBT vs. Standard CBT
| NCT ID | NCT05943171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Substance Use Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-11-27 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-11-27 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: Participants between the ages of 18-65 will be 40 men entering outpatient treatment who (1) meet current DSM-V criteria substance dependence (and use alcohol and/or stimulants within the 30 days prior to the screening session); (2) report verbal aggression, conflict/aggression in a current intimate relationship (e.g., yelling, screaming, pushing, slapping) within 30 days prior to screening; and (3) can read English at a 6th grade level. Exclusion Criteria: Participants will be excluded if they: 1) Are currently in withdrawal from substance and in need of detoxification (such individuals may be re-evaluated following detoxification); 2) Have cognitive impairment (a mini mental state score \<25); 3) Have psychomotor epilepsy (e.g. impulsivity or rage related symptoms secondary to a seizure disorder, as this medical diagnosis is likely to be a confound in the proposed study); 4) Have major medical complications such as a head injury/trauma, or HIV dementia that may also be a confound in the study interventions; 5) Are currently receiving either substance abuse or IPV treatment elsewhere; 6.) Have a lifetime history of any psychotic or bipolar disorder; or 7) Are currently suicidal or homicidal or 8) severe violence (punching, chocking, use of weapons).
Contact & Investigator
James Filingeri
STUDY CHAIR
University of Rochester
Frequently Asked Questions
Who can join the NCT05943171 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 65 Years, studying Substance Use Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05943171 currently recruiting?
Yes, NCT05943171 is actively recruiting participants. Contact the research team at caroline_easton@urmc.rochester.edu for enrollment information.
Where is the NCT05943171 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05943171 clinical trial?
NCT05943171 is sponsored by University of Rochester. The principal investigator is James Filingeri at University of Rochester. The trial plans to enroll 40 participants.