Recruiting

RITch®CBT

Sponsor:

University of Rochester

Code:

NCT05943171

Conditions

Substance Use Disorders

Alcohol Use Disorder

Stimulant-Related Disorder

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Cognitive Behavioral Therapy

Standard CBT

Study Details

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.

Conditions

Substance Use Disorders

Alcohol Use Disorder

Stimulant-Related Disorder

Study ID

NCT05943171

Start date

Nov 27, 2025

Status verified date

Jan, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Digital RITch®CBT

(Digital RITch®CBT) is a Digital Avatar Assisted Interactive CBT Treatment

active comparator: Human Administered CBT

Standard CBT is a human administered CBT Treatment

Interventions

Cognitive Behavioral Therapy

Digital treatment that deploys CBT.

Standard CBT

Human Administered Manualized CBT

Primary outcome measure

  • Substance Use Cravings [ Time Frame: 84 days of treatment ]

Central Contacts and Locations

Locations

Strong Recovery - Part Of Strong Memorial Hospital

Recruiting

Rochester, New York, United States, 14623

Contacts

Principal Investigator:

Caroline Easton, PhD

More Information

Sponsor

University of Rochester

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-01-26.