By InvitationNot Applicable

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

United States24 participantsStarted 2025-12-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. adults aged 18 to 65,
✓. currently admitted to a transitional living program for opioid use and within the first 30 days of admission
✓. voluntarily agree to participate and demonstrate adequate decision-making capacity as determined by the study team during informed consent
✓. able to read and speak English,
✓. have a clinical diagnosis of OUD at any severity level, whether mild, moderate, or severe,
✓. identify opioids as their primary drug of choice
✓. should have access to smartphones for daily individual practice of the intervention.
✓. must reside at the treatment program for the duration of the study

Exclusion criteria

✕. inability to provide informed consent,
✕. inability to demonstrate adequate decision-making capacity

What they're measuring

Recruitment Rate (Feasibility)

Timeframe: From study launch through completion of recruitment

Retention Rate (Feasibility)

Timeframe: Time Frame: From enrollment through completion of the 3-week intervention

HRVB Practice Adherence (Feasibility)

Timeframe: From enrollment through completion of the 3-week intervention

Daily Diary Compliance (Feasibility)

Timeframe: From enrollment through completion of the 3-week intervention

Intervention Acceptability Rating (Acceptability)

Timeframe: At the post-intervention assessment (T2), immediately following completion of the intervention

Qualitative Acceptability Feedback (Acceptability)

Timeframe: At the post-intervention assessment (T2), immediately following completion

Trial details

NCT IDNCT07361731

SponsorArizona State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03

View on ClinicalTrials.gov More Autonomic Nervous System Imbalance trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. adults aged 18 to 65,
✓. currently admitted to a transitional living program for opioid use and within the first 30 days of admission
✓. voluntarily agree to participate and demonstrate adequate decision-making capacity as determined by the study team during informed consent
✓. able to read and speak English,
✓. have a clinical diagnosis of OUD at any severity level, whether mild, moderate, or severe,
✓. identify opioids as their primary drug of choice
✓. should have access to smartphones for daily individual practice of the intervention.
✓. must reside at the treatment program for the duration of the study

Exclusion criteria

✕. inability to provide informed consent,
✕. inability to demonstrate adequate decision-making capacity

What they're measuring

Recruitment Rate (Feasibility)

Timeframe: From study launch through completion of recruitment

Retention Rate (Feasibility)

Timeframe: Time Frame: From enrollment through completion of the 3-week intervention

HRVB Practice Adherence (Feasibility)

Timeframe: From enrollment through completion of the 3-week intervention

Daily Diary Compliance (Feasibility)

Timeframe: From enrollment through completion of the 3-week intervention

Intervention Acceptability Rating (Acceptability)

Timeframe: At the post-intervention assessment (T2), immediately following completion of the intervention

Qualitative Acceptability Feedback (Acceptability)

Timeframe: At the post-intervention assessment (T2), immediately following completion