| CTRI Number |
CTRI/2025/02/081434 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A BRIEF MOTIVATIONAL INTERVENTION FOR CANNABIS USE DISORDER |
|
Scientific Title of Study
|
ASSESSING THE EFFICACY OF A BRIEF MOTIVATIONAL INTERVENTION FOR CANNABIS USE DISORDER |
| Trial Acronym |
BMIC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sidharth Mishra |
| Designation |
Research scholar |
| Affiliation |
Kalinga Institute of Medical sciences |
| Address |
Room No: 1 Department Psychiatry
Kalinga institute of medical sciences, KIIT university, Patia
Khordha
ORISSA
751024
India |
| Phone |
9861161128 |
| Fax |
|
| Email |
mishra.sidharth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudipta Das |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Medical sciences |
| Address |
Room No: 1 Department Psychiatry
Kalinga institute of medical sciences, KIIT university, Patia
Khordha
ORISSA
751024
India |
| Phone |
9861161128 |
| Fax |
|
| Email |
sudipta.das@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sidharth Mishra |
| Designation |
Research scholar |
| Affiliation |
Kalinga Institute of Medical sciences |
| Address |
Room No: 1 Department Psychiatry
Kalinga institute of medical sciences, KIIT university, Patia
ORISSA
751024
India |
| Phone |
9861161128 |
| Fax |
|
| Email |
mishra.sidharth@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kalinga Institute of Medical sciences |
| Address |
KIIT deemed to be university |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pranab Mahapatra |
Kalinga Institute of Medical sciences |
Room No 1, Department of Psychiatry
Khordha
ORISSA |
7752085533
pranab.mahapatra@kims.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASSESSING THE EFFICACY OF A BRIEF MOTIVATIONAL INTERVENTION FOR CANNABIS USE DISORDER |
Brief Motivational Intervention for Cannabis Cessation (BMIC) and Treatment as Usual (TAU) |
| Comparator Agent |
Control intervention |
Involves empathic listening, discussion of cannabis use within the context of the participants goals and values, consideration of the costs and benefits of cannabis use, and decision-making support. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be recruited from the inpatient and outpatient departments of KIMS, as well as from residential treatment facilities for substance abuse and cannabis. Participants will range in age from 18 to 60 years old. Patients meeting the DSM-5 criteria for moderate to severe cannabis use disorder,the possibility of having co-morbid substance use disorders, and expressing a willingness to participate and remaining accessible for follow-up assessments are all requirements for participants to be eligible for the study. |
|
| ExclusionCriteria |
| Details |
Severe mental disorders, organic brain pathology, intellectual disability. Comorbid psychiatric disorders before substance use shall be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 2. Cannabis Problems Questionnaires -- quantifies negative social, occupational, physical and legal consequences of cannabis use across 16 items |
Cannabis Problems Questionnaires -- quantifies negative social, occupational, physical and legal consequences of cannabis use across 16 itemss
Drug Toxicology report shall be added for abstinence markers.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in cannabis-related problems, intensity of cannabis craving, withdrawal symptoms, depression, anxiety, stress levels, and perceived social support |
at baseline (before the intervention begins), at 4 weeks (mid-intervention), and at 8 weeks (post-intervention). These assessments capture changes over the course of treatment in areas such as cannabis-related problems, craving intensity, withdrawal symptoms, levels of depression, anxiety, stress (via DASS-21), and perceived social support (via MSPSS), as well as abstinence confirmed through urine tests |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
15/03/2025 |
| 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)
|
Open to Recruitment |
| 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
Modification(s)
|
This is a single-blind randomized controlled trial evaluating the efficacy of a Brief Motivational Intervention for Cannabis (BMIC) among adults with Cannabis Use Disorder (CUD). Participants aged 18–65 years meeting DSM-5/ICD-11 criteria for mild to severe CUD will be randomized to receive either BMIC in addition to Treatment-as-Usual (TAU) or TAU alone. The amended protocol (Version 1.2, November 2025), ratified by the Institutional Ethics Committee, refines the primary outcome to reduction in cannabis craving measured using the Brief Substance Craving Scale (BSCS) at Day 14. Secondary outcomes include frequency and quantity of cannabis use assessed by Timeline Follow-Back, withdrawal severity, psychological distress, and urine-verified abstinence at discharge and follow-up. The intervention comprises structured motivational interviewing sessions with booster follow-up, while the control arm receives TAU only. The revised sample size is 100 participants (50 per arm), powered to detect a clinically meaningful change in craving. Participant safety will be monitored throughout the study, and results will be disseminated through peer-reviewed publications. |