NCT07361731

Evaluating the Feasibility, Acceptability, and Preliminary Outcomes of Heart Rate Variability Biofeedback for Individuals With Opioid Use Disorder.

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Arizona State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary outcomes of a heart rate variability biofeedback (HRVB) intervention among adults with opioid use disorder (OUD) receiving residential treatment. The study aims to learn whether HRVB can be implemented successfully in this setting and whether it may help participants manage stress, emotional regulation, and cravings. The main questions this study aims to answer are: Is HRVB feasible and acceptable for adults with OUD in a residential treatment program, as indicated by recruitment, retention, adherence, and participant satisfaction? Do participants show preliminary improvements in stress, affect, emotional regulation, self-efficacy, and cravings following participation in the HRVB intervention? Participants will be adults with OUD enrolled in a residential treatment program. Participants will: 1. Complete baseline and post-intervention questionnaires assessing stress, affect, emotional regulation, social support, self-efficacy, and cravings 2. Participate in daily HRVB practice using a portable biofeedback device for approximately 3 weeks 3. Complete brief daily diary assessments related to mood, stress, and cravings This is a single-arm pilot study designed to inform the feasibility and future refinement of HRVB as an adjunct intervention for individuals with OUD in residential treatment settings.

Conditions

• Autonomic Nervous System Imbalance
• Heart Rate Variability (HRV)
• Opioid Use Disorder
• Breathing Techniques
• Opioid Craving
• Recovery
• Emotional Regulation
• Positive and Negative Affect
• Stress
• Biofeedback

Interventions

Type	Name	Description
BEHAVIORAL	Heart rate variability biofeedback	Participants non-randomized to the single intervention arm will receive a standardized HRV sensor and accompanying smartphone application, along with a 30-45-minute HRVB training session focused on using biofeedback signals to generate a resonant frequency pattern of HRV (coherence) following baseline data collection. Participants will be asked to practice their HRVB skills at home for 10 minutes per day over a 3-week period.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States