Heart Rate Variability Biofeedback for Opioid Use Disorder

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: MAOIs, Alpha/beta blockers, Benzodiazepines

Disqualifiers: Suicidal thoughts, Psychotic symptoms, Serious cardiac condition, Dementia, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether heart rate variability biofeedback (HRVB) can assist individuals with opioid use disorder (OUD) in a residential treatment program in managing stress and cravings. Participants will use a biofeedback device daily for about three weeks and complete questionnaires to assess the treatment's effectiveness. The study seeks adults who have been in a residential program for opioid use for less than 30 days and identify opioids as their primary substance of use. As an unphased trial, it provides a unique opportunity to explore innovative stress management techniques.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications like MAOIs, alpha/beta blockers, or benzodiazepines to participate in this trial.

What prior data suggests that heart rate variability biofeedback is safe for adults with opioid use disorder?

Research has shown that heart rate variability biofeedback (HRVB) is generally safe for most people. Studies have found that HRVB can reduce negative feelings and cravings in individuals with substance use disorders, without reporting any serious side effects.

Participants in these studies practiced HRVB for several weeks and found it manageable, experiencing no harmful effects and continuing the treatment without issues. HRVB uses a device to help control breathing and calm the nervous system, making it a non-invasive and low-risk method.

While individual experiences can vary, current research suggests that HRVB is a safe option for managing stress and cravings, particularly for those recovering from substance use disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about heart rate variability biofeedback for opioid use disorder because it offers a non-drug approach to treatment, which sets it apart from standard medications like methadone and buprenorphine. This biofeedback method helps individuals gain control over their physiological responses, potentially reducing cravings and withdrawal symptoms without the side effects associated with pharmacological treatments. By enhancing self-regulation and emotional resilience, this technique could empower patients to manage their condition more effectively and sustainably.

What evidence suggests that heart rate variability biofeedback is effective for opioid use disorder?

Research shows that heart rate variability biofeedback (HRVB), which participants in this trial will receive, might help people with opioid use disorder (OUD). Studies have found that individuals with OUD often exhibit lower heart rate variability, linked to stress and emotional challenges. Early research suggests that HRVB could reduce cravings and negative feelings in those dealing with substance use disorders. This technique employs a device to help control heart rates, potentially improving stress and emotion management. Initial results are promising, indicating that HRVB may support recovery by easing stress and cravings. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with opioid use disorder (OUD) who are currently in a residential treatment program. It's designed to see if heart rate variability biofeedback (HRVB) can help them manage stress, emotional regulation, and cravings.

Inclusion Criteria

I am between 18 and 65 years old.

Should have access to smartphones for daily individual practice of the intervention

I have been diagnosed with opioid use disorder at any severity.

Exclusion Criteria

Currently enrolled in any other biofeedback program simultaneously

History of receiving previous HRVB training

A known self-reported diagnosis of dementia, a severe brain injury, or a serious neurological condition (e.g., Parkinson's disease)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in daily HRVB practice using a portable biofeedback device and complete daily diary assessments for approximately 3 weeks

3 weeks

Daily practice and assessments

Follow-up

Participants complete post-intervention assessments to evaluate stress, emotional regulation, and cravings

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Heart rate variability biofeedback

Trial Overview

The study tests the feasibility and acceptability of HRVB as an intervention. Participants will practice daily HRVB using a portable device for about three weeks while completing questionnaires on mood and cravings.

How Is the Trial Designed?

Group I: HRVB Intervention group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10234179/

Association Between Opioid Use Disorder and Blunted Heart ...

Results showed that resting HF-HRV was significantly lower for patients with OUD than for those without OUD (p< .001, d = .36), indicating deficits in autonomic ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07361731

Study Details | NCT07361731 | Evaluating the Feasibility, ...

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

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12489796/

Heart Rate Variability Biofeedback for Substance Use Disorder

Preliminary studies suggest heart rate variability biofeedback (HRVB) may reduce craving and negative affect in individuals with substance use disorder ...

4.

researchgate.net

researchgate.net/publication/363274891_Association_between_opioid_use_disorder_and_blunted_heart_rate_variability_among_opioid-treated_chronic_pain_patients

Association between opioid use disorder and blunted heart ...

A study has shown that patients with OUD have lower resting-state high-frequency heart rate variability when compared to patients without OUD, suggesting a ...

5.

docwirenews.com

docwirenews.com/post/heart-rate-variability-biofeedback-shows-promise-for-substance-use-disorder-treatment

Heart Rate Variability Biofeedback Shows Promise for ...

The findings suggest second-generation HRVB can reduce negative affect, craving, and substance use among individuals in early recovery from SUD.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41032322/

Heart Rate Variability Biofeedback for Substance Use Disorder

Intervention: Eight weeks of HRVB. Main outcomes and measures: The primary outcomes were negative affect, positive affect, craving, and ...

7.

researchgate.net

researchgate.net/publication/396050232_Heart_Rate_Variability_Biofeedback_for_Substance_Use_Disorder_A_Randomized_Clinical_Trial

Heart Rate Variability Biofeedback for Substance Use ...

Importance Preliminary studies suggest heart rate variability biofeedback (HRVB) may reduce craving and negative affect in individuals with ...