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CTRI Number  CTRI/2021/09/036870 [Registered on: 27/09/2021] Trial Registered Prospectively
Last Modified On: 27/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Including the concept of Identifying and giving brief advice for alcohol, tobacco and other drug users into the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke. 
Scientific Title of Study   Integrating Screening and Brief Intervention for Substance Use Disorders into National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anusha Viswanathan 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal, MAHE 
Address  Department of Community Medicine 3rd Floor Kasturba medical College MAHE Opposite tiger circle Manipal Udupi Karnataka-576104

Udupi
KARNATAKA
576104
India 
Phone  9940013215  
Fax    
Email  anusha.viswanathan@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Muralidhar M Kulkarni 
Designation  Associate Professor 
Affiliation  Department of Community Medicine, Kasturba Medical College, Manipal, MAHE 
Address  Department of Community Medicine 3rd Floor Kasturba medical College MAHE Opposite tiger circle Manipal Udupi Karnataka-576104

Udupi
KARNATAKA
576104
India 
Phone  9844810917  
Fax    
Email  murali.kulkarni@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Samir Kumar Praharaj 
Designation  Professor and Head 
Affiliation  Department of Psychiatry, Kasturba Medical College, Manipal, MAHE 
Address  Department of Psychiatry Kasturba Hospital MAHE Manipal Udupi Karnataka-576104

Udupi
KARNATAKA
576104
India 
Phone  8971026304  
Fax    
Email  samir.kp@manipal.edu  
 
Source of Monetary or Material Support  
KMC MANIPAL 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anusha Viswanathan  Kasturba Medical College Manipal  Community Medicine Department Primary Health care settings 1234
Udupi
KARNATAKA 
9940013215

anusha.viswanathan@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee KMC Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Substance Use 
Patients  (1) ICD-10 Condition: F102||Alcohol dependence, (2) ICD-10 Condition: F172||Nicotine dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cessation Trial  The objective is to study the impact of Screening with help of “The Alcohol, Smoking and Substance Involvement Screening Test” (ASSIST) Score and Brief Intervention (BI) in quitting Substance use among substance users (Nicotine and alcohol use only) BRIEF INTERVENTION is a brief motivational conversation between a health care professional and a substance user which focuses on encouraging healthy choices so that the risk behaviours are quit. The Community Medicine department runs five peripheral health centres of which One centre will be chosen as the CONTROL and another centre for INTERVENTION to avoid contamination. There will be 4-time points in this trial -baseline, 1st month, 3rd month and end line (6th month). At baseline – The moderate risk substance users (as identified from the ASSIST TOOL) will be subjected to lab investigations (venous blood sample for GGT among alcohol users and urine sample for urine cotinine among nicotine users) in both arms. Further, BI will be administered to subjects in the intervention arm only. At 1st month and 3rd month- The patients in both the arms will receive a 5-10-minute follow-up phone call, where PI will assess ASSIST score and enquire about the status of substance use. Further, adherence to the BI advice as well as any progress towards change will be enquired in the intervention arm alone. At end line (6th month) personal follow-up- ASSIST scoring and the same lab investigations carried out at baseline will be repeated at the primary care centre to see the impact of Screening and brief intervention in quitting substance use in both arms. The BI will then be given to the control arm so that they are not deprived of the intervention. The total duration to achieve this objective will be 6 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients coming to primary care centres will be included in the study if they are aged 18 and above.
Patients who will be alert and oriented to time, place and person.
Participant whose ASSIST score shows moderate risk during screening
 
 
ExclusionCriteria 
Details  : Planned to leave the area in the next six months;
Not providing reliable contact information to complete the follow-up procedures;
Were currently in a residential substance abuse treatment facility.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of brief intervention (BI) on QUITTING substance use.
 
There will be 4-time points in this trial -baseline, 1st month, 3rd month and end line (6th month) wherein substance usage status, ASSIST score will be evaluated in control and intervention arms. Additionally, at baseline and end-line (6th month) - the lab investigations (GGT among alcohol users and urine cotinine among nicotine users) will be carried out to see the impact of Screening and brief intervention in quitting substance use in both arms.
 
 
Secondary Outcome  
Outcome  TimePoints 
The study outcomes are thus likely to provide us the means to incorporate the Screening and Brief interventions for SUDs into the existing NPCDCS program which will in future ensure provision of tackling the menace of substance use in the country at primary health care level.  2 years 
 
Target Sample Size   Total Sample Size="1120"
Sample Size from India="1120" 
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)   28/09/2021 
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="2"
Months="0"
Days="0" 
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  

This study aims to identify the factors associated with substance use; barriers and facilitators for incorporating Screening and Brief Intervention (SBI) for Substance Use Disorders (SUDs) at primary level; and effectiveness of this intervention on substance use and thereby provide valuable insights for integrating this strategy into the ongoing National Programme for prevention & Control of  Cancer, Diabetes, Cardiovascular diseases & Stroke (NPCDCS).

Objectives of this study:

Objective 1: To explore the barriers and facilitators for implementing screening and brief intervention (SBI) for Substance use disorders at primary health care settings.

Objective 2: To estimate the proportion of substance users among people seeking health care services at primary health care settings and to study the factors associated with substance use.

Objective 3To study the impact of SBI in quitting substance use.

 

Sample size for 3 objectives are mentioned below:-

Objective 1: In-Depth Interview (IDI) will be conducted among 12-15 participants that comprise of Primary care physicians; health care providers like nurses, medical social workers; NCD coordinators and the NPCDCS program officer after obtaining their consent.

Objective 2:  1108 (calculated using prevalence of substance use = 15% (Panda et al)

 

Total sample size is 1120 (12 participants from objective 1 + 1108 participants from objective 2)

 

Objective 3: The Sample size is found to be 82. Thus, the control arm will have 41 and the intervention arm will have 41 participants

 
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