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CTRI Number  CTRI/2022/01/039182 [Registered on: 05/01/2022] Trial Registered Prospectively
Last Modified On: 30/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Development and Testing a Counseling strategy for drug and alcohol misuse in prisons.  
Scientific Title of Study   Enhanced ASSIST-linked brief intervention and referral to treatment for illicit Drugs and alcohol use in prison population: a double-blind randomized clinical trial (HAMDARD) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Debasish Basu 
Designation  Professor & Head 
Affiliation  Postgraduate Institute of Medical Education and Research Chandigarh accredited by NAAC 
Address  Postgraduate Institute of Medical Education and Research
Department of Psychiatry PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9876826618  
Fax    
Email  db_sm2002@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Debasish Basu 
Designation  Professor & Head 
Affiliation  Postgraduate Institute of Medical Education and Research Chandigarh accredited by NAAC 
Address  Postgraduate Institute of Medical Education and Research
Department of Psychiatry PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9876826618  
Fax    
Email  db_sm2002@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Debasish Basu 
Designation  Professor & Head 
Affiliation  Postgraduate Institute of Medical Education and Research Chandigarh accredited by NAAC 
Address  Postgraduate Institute of Medical Education and Research
Department of Psychiatry PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  9876826618  
Fax    
Email  db_sm2002@yahoo.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V.Ramalingaswami Bhawan,P.O.Box No.4911, Ansari Nagar, New Delhi - 110 029, India.  
Type of Sponsor  Government funding agency 
 
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 Debasish Basu  Postgraduate Institute of Medical Education and Research  Room No: 01 First Floor Drug De-addiction and Treatment Centre. Department of Psychiatry PGIMER, Chandigarh
Chandigarh
CHANDIGARH 		 9876826618

db_sm2002@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ASSIST screening and general information  The control group will also be screened by ASSIST but would not receive brief intervention. In the second and third session, the control group will receive general information on alcohol and drugs, respectively. General information will entail harms associated with drugs and alcohol, availability and effectiveness of treatment services. General information will be told in a didactic manner. A leaflet containing similar information will be given as takeaway to the willing participants. 
Intervention  Screening and brief intervention   It consist of three phases – formative, intervention, and post-intervention process evaluation. The first phase of the study will be done in the Ambala prison in Haryana. It will consist of in-depth interviews (IDI) and focused group discussions (FGD)with the prison inmates using drugs and alcohol, prison health care providers, and administrators. The active ingredients of the evidence-based psychosocial interventions for the treatment of substance use disorders include “support, goal direction, and structure; an emphasis on rewards that compete with substance use, a focus on abstinence-oriented norms and models, and attempts to develop self-efficacy and coping skills. The second phase of the study will determine the feasibility, acceptability and preliminary effectiveness of enhanced SBIRT through a pilot randomized controlled trial. The inmates of one of these prisons will be randomly allocated to receive the experimental intervention (enhanced ASSIST-linked SBIRT) and the inmates of the other prison will receive control intervention (screening and information dissemination). Experimental (enhanced-ASSIST-linked brief intervention and referral to treatment): ASSIST gives a risk score for each substance and the users can be categorized into three risk groups- ‘low’, ‘moderate’, and ‘high.’ For all the illicit drugs a score from 0-3, 4- 26, and 26 are considered to be ‘low’, ‘moderate’, and ‘high’ risk categories, respectively. The ‘low-risk’ category for alcohol is an ASSIST score of 0-10. Moderate and high-risk scores of 11-26 and 26 are kept. The moderate-risk groups will be recruited for the study. The low-risk group will receive a single group session of 20-30minutes on the harmful effects of drug and alcohol and the high-risk group will be referred to the linkage services. Low and high-risk groups will not be included in the study. The ‘moderate risk’ group will receive the enhancedSBIRT consisting of three individual sessions of 20-30 minutes duration. This is “enhanced” SBIRT because it will have two additional components to the traditional SBIRT. The first session will entail screening by ASSIST and brief intervention (feedback, advice on behavior change, providing a menu of options, and working on self-efficacy). The ASSIST feedback report card will be used for the feedback on participants’ substance use. Feedback will also be given regarding the HIV, HCV status (if applicable).The first session is the standard SBIRT. The content of the next two sessions will be developed by the first stage of the study, i.e. the qualitative component. Broadly, these two sessions will consist of modulating the outcome expectancies, self-efficacy and coping, dealing with craving, risk reduction strategies, and establishing and enhancing social networks. Follow-up assessment with ASSIST and other measures(as already discussed) will be done after 12 weeks and 24 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASSIST score in the “moderate risk”. If the participant scores within the moderate-risk range for two or more of the target drugs, the intervention will be focused on the highest-scoring substance or the substance that is of most concern to the participant. Alcohol, in any case, receive the intervention. Inmates who will remain in the prison for at least 6 months following intervention; for under-trial prisoners, it will be decided on the basis of the next date of the court hearing.  
 
ExclusionCriteria 
Details  Only tobacco use
Unable to provide informed consent for cognitive impairment.
Not willing to participate in the intervention and for follow-up assessments 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To develop the “enhanced” component of SBIRT
2. Feasibility and acceptability of brief intervention for substance use disorders in prison population
3. Reduction in the ASSIST score by more or equal to 7 points in the intervention arm compared to the control arm. 		 Third and Sixth months.  
 
Secondary Outcome  
Outcome  TimePoints 
1. To identify the facilitators and barriers of the uptake of the intervention and to
modify the intervention accordingly.
2. Reduction in the frequency of illicit drug use in the intervention arm compared to
the control
3. Reduction in frequency of drinking days and heavy drinking days in the intervention arm compared to the control.
4. Reduction of re incarceration
5. Reduction of high-risk behavior.
6. Reduction of overdose risk.  		 12 months 
 
Target Sample Size   Total Sample Size="376"
Sample Size from India="376" 
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)   15/01/2022 
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 Yet Recruiting 
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  

Introduction:

A systematic review & meta-analysis found that the prevalence of drug use in prisons ranges from 10%-60% among men and 30%-70% among women. Moreover, many prisoners would have been imprisoned because of their drug use (in countries where drug use has been criminalized, e.g., India). The drug-related deaths increased three to eight-fold in the first two weeks of discharge,6. Therefore substance use in prison poses a severe risk to public health and society. Indian prisons lack a systemic approach to dealing with substance use disorders. An otherwise effective intervention, the ASSIST-linked enhanced SBIRT, could be tested in the resource-limited prison settings of India. If it is effective, it can address the treatment gap and reduce substance use and other substance-related complications in the prison population. A study of the predictors of response to the SBIRT should help optimize the available resources. SBIRTcould also creates a window of opportunity for the decriminalization of drug use by making treatment available, accessible, acceptable, and affordable to those imprisoned for the possession of small quantities of drugs. 

Objectives:  

To develop and test the enhanced-SBIRT for risky substance use. 

To explore the barriers and facilitators of the intervention.

Methods:

 The study will consist of formative, intervention, and post-intervention phases. The formative stage will have in-depth interviews and focus group discussions. The manually coded transcribed data will generate the themes and sub-themes for developing the “enhanced” component of the SBIRT. The intervention phase will be a double-blind, individual-based, parallel-design RCT (n=188 in each arm after power calculation). Results access may begin at 12 and 24 weeks after intervention. This phase is to determine the feasibility and preliminary efficacy of the intervention. Capability, Opportunity, Motivation-Behaviour change theoretical framework will be used to understand the processes in the final phase of the post-intervention process evaluation. 

Expected outcome: 

The newly developed enhanced-SBIRT should be feasible and acceptable to the Indian prison population. It will reduce the severity, frequency of substance use, and will have a significant reduction in high-risk behaviour and overdose risk. The intervention will be tested at the state and even at the national level. 

 
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