Safe & Sound Protocol in Adults With Trauma and SUD

NCT ID
NCT07219056
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Caron Treatment Centers
Conditions
Anxiety, Posttraumatic Stress Symptom, Substance Use Disorders

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: The Effect of the Safe and Sound Protocol on Emotional Regulation in Traumatized Adults With Substance Use Disorders

Enrollment: 100 participants (Estimated).

What is being studied

  • Device: Safe and Sound Protocol

Who may be eligible

Ages
18 Years to 75 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Ages 18 years old to 75 years old * In residential treatment for substance use disorder. * Has a history of trauma and is enrolled in Caron's trauma programming * Is proficient in English * Able to provide written informed consent. * Stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: * Does not speak English * Age \< 18 or \> 75 * Does not have a history of trauma * Active psychosis * Active or uncontrolled seizures * Tinnitus * Active suicidal ideation * Actively engaging in self-injurious behavior * Severe neurological condition * Diagnosis of autism * Has any serious medical disease or mental health condition which, in the judgment of the Principal Investigator or his/her designee, would make study participation unsafe, or would make intervention compliance difficult.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Pennsylvania, United States: 1

Sample of listed locations

  • Caron Treatment Centers — Wernersville, Pennsylvania, 19565, United States — Recruiting

Study details

Start date
December 15, 2025
Primary completion date
December 30, 2026
Completion date
March 15, 2027
First posted
October 21, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07219056
Registry last updated
September 21, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07219056 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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