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

University of Rochester · with National Institute on Drug Abuse (NIDA) · NCT05943171

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · Men only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
40
US sites recruiting
1
Study start
November 27, 2025
Record last updated
January 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Cognitive Behavioral Therapy; Standard CBT

Conditions: Substance Use Disorders; Alcohol Use Disorder; Stimulant-Related Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

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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).

Recruiting US locations

  • Strong Recovery - Part Of Strong Memorial Hospital

    Rochester, NY 14623

    Site contact: Sage Garcia Agrait · Sage_GarciaAgrait@urmc.rochester.edu

Study contacts (from the official record)

  • Caroline J Easton, PhD · 585-475-4065 · caroline_easton@urmc.rochester.edu
  • Cory Crane, PhD · 585- · cory_crane@urmc.rochester.edu
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