| CTRI Number |
CTRI/2026/04/108925 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
04/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Biofeedback] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Effect of single session of breathing-based heart control training on body autonomic functions and thinking ability in people with opioid addiction." |
|
Scientific Title of Study
|
Effect of single session heart rate variability biofeedback on autonomic and cognitive function in patients with opioid use disorder: A pilot study |
| Trial Acronym |
HRV-OUD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
2026A, Teaching block, Department of Physiology, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8377933797 |
| Fax |
|
| Email |
drakanksha111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritesh |
| Designation |
MSc. Student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
2026A, Teaching block, Department of Physiology, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
7206012597 |
| Fax |
|
| Email |
riteshgupta72060@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
2026A, Teaching block, Department of Physiology, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8377933797 |
| Fax |
|
| Email |
drakanksha111@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, INDIA -110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
All India Institute of Medical Sciences (AIIMS), Ansari Nagar, NEW DELHI-110029, INDIA |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akanksha SIngh |
All India Institute of Medical Sciences |
Biofeedback Clinic, Room no. 2050, Department of Physiology, 2nd Floor, Teaching Block, AIIMS, Ansari NAgar, New Delhi - 110029
South
DELHI |
8377933797
drakanksha111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Participants in this group will undergo single session of quiet sitting with regular breathing for 20 minutes. |
| Intervention |
HRV Biofeedback |
Participants will receive single session of HRV Biofeedback of 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Subjects with addictive disorders for duration of at least 12 months as diagnosed by DSM-5 criteria
2. less than 7 days of initiation of buprenorphine therapy
3. Right-handed subjects
4. Subject able to perform computer task.
5. Could give informed consent.
|
|
| ExclusionCriteria |
| Details |
1. H/o any psychiatric disease other than substance related and addictive disorder
2. H/o any neurological disorder
3. Chronic physical illnesses (excluded based on clinical history)
4. HIV seropositivity
5. H/o colour blindness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HF, LF, LF/HF ratio |
2 time points:
1. At baseline
2. Immediately after the HRV biofeedback seesion/control quiet sitting session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
14/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
OUD is characterized by dysregulation of the brain’s reward system, including the mesolimbic dopamine pathway, prefrontal cortex, and amygdala. Its association with maladaptive neuromodulation affecting executive function, emotional regulation, and stress responses, contributes to disease pathophysiological features like craving, relapse and cognitive effects. Studies show positive correlation between stressful life events and high probability of relapse, highlighting the need for stress management techniques that can address the need based acute management of stress at the incidence of high stress life events. Studies have shown that HRV Biofeedback can reduce stress and improve emotional and cognitive functions in healthy subjects.Therefore, the present pilot randomized controlled trial is planned to study the effect of single session HRV Biofeedback training on the autonomic and cognitive function, stress, craving and withdrawal in patients of OUD during early agonist detoxification. The results of the present study can be useful in the determining the role of HRV Biofeedback as an adjunct to the main treatment strategy to support recovery by helping acute management of stressful life events which otherwise are the precipitators of relapse. |