| CTRI Number |
CTRI/2024/01/062107 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Family Counselling for Opioid Addiction |
|
Scientific Title of Study
|
A Randomized Control Trial of Family Intervention for patients with Opioid Dependence |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yesh Chandra Singh |
| Designation |
Senior Resident |
| Affiliation |
Department of Psychiatry and NDDTC, AIIMS, New Delhi |
| Address |
Department of Psychiatry and NDDTC, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
yeshsingh91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Siddharth Sarkar |
| Designation |
Additional Professor |
| Affiliation |
Department of Psychiatry and NDDTC, AIIMS Delhi |
| Address |
Department of Psychiatry and NDDTC, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
sidsarkar22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yesh Chandra Singh |
| Designation |
Senior Resident |
| Affiliation |
Department of Psychiatry and NDDTC, AIIMS, New Delhi |
| Address |
Department of Psychiatry and NDDTC, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
yeshsingh91@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Psychiatry and NDDTC, Room No. 4096, 4th floor, Teaching Block, AIIMS New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Yesh Chandra Singh |
AIIMS |
Room No. 4096, 4th floor, Department of Psychiatry and NDDTC
South
DELHI |
9458253089
yeshsingh91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F112||Opioid dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family Intervention |
3 sessions of family intervention each spaced 2 weeks apart |
| Comparator Agent |
Nil |
Treatment as usual |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
For patients:
Diagnosis of opioid dependence syndrome
In early phase of maintenance treatment, either buprenorphine or naltrexone (initiated within 3 months)
Willing to engage in the intervention
Access to phone
For family members:
1.Family member staying with the patient
2.Aged 18 and above
3.Planning to stay with the patient during the course of intervention and willing to participate in the family intervention
4.Patient willing to participate with the particular member in the intervention
|
|
| ExclusionCriteria |
| Details |
For patients
1. Exposure to any structured psycho-social intervention for opioid use
2. Those who are intoxicated or in severe withdrawal which precludes an interview
3. Currently suffering from a psychotic illness
4. Psychiatric or medical comorbidity that precludes an interview
For family members
1. Suffering from any substance use disorder except tobacco use disorder
2. Psychiatric or medical comorbidity that precludes an interview
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in family functioning of the family intervention group with the control group as measured on Family assessment device. |
At 0 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the change of opioid use in the family intervention group with the control group. |
Baseline, 4 weeks, 8 weeks, 12 weeks |
| To ascertain the therapist, patient and family member’s perspectives on family intervention |
after sessions |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/02/2024 |
| 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="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim - To compare the change in family functioning of patients and family members who receive family intervention, to treatment as usual in patients with opioid use disorder. Objectives - To compare the change in family functioning of the family intervention group with the control group. To compare the change of opioid use in the family intervention group with the control group. To ascertain the therapist, patient and family member’s perspectives on family Rationale - Family members in India are often involved in the treatment and their wishes are an important factor in the decision making and treatment process. They provide support for treatment of the substance user in many ways. There is sufficient evidence for involving family members for the treatment of patients with substance use disorders. Psychological interventions have been found to be useful for treatment of opioid use disorders. Intervention with family members, in the Indian context, can be a helpful approach to provide treatment to patients with opioid use disorder.
Procedure: Screening will be performed to recruit patients with opioid use disorder registered at NDDTC OPD. The purpose of screening is to assess the suitability of the patient for inclusion in this study based on the inclusion criteria. The patients meeting the recruitment criteria for the study will be informed about the aims and objectives of the research, study procedures, nature of participation and rights of the study participants. If the patient is willing to participate in the study after receiving adequate information, he would be invited to sign the consent form for the study which is available in both English and Hindi. A detailed assessment of the subjects recruited into the study will be performed on the 1st day only after taking written informed consent. The patients would be randomized to either of the study arms by the simple random allocation (1:1). Computerized random sequences would be generated and allocated into group A (Intervention group) or B (Control group). Intervention would comprise of sessions with family members (up to 3), conducted over a period of 4 weeks. Assessments of both of the groups would be conducted using Maudsley Addiction Profile at Week 4 and 8. At week 12, assessment will be done with Family Assessment Device and Maudsley Addiction Profile.
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