| CTRI Number |
CTRI/2025/11/097181 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Can CBD Help People Recover from Opioid Addiction? |
|
Scientific Title of Study
|
Cannabidiol as an Adjunctive Therapy in Opioid Agonist Treatment for
Patients with Opioid Dependence An Open-Label Study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arashdeep Singh |
| Designation |
Junior Resident |
| Affiliation |
Central Institute of Psychiatry, Ranchi |
| Address |
Room No: 58, Al Razi New Postgraduate Hostel, Central institute Of psychiatry, Kanke, Ranchi, Jharkhand, India
Ranchi
JHARKHAND
834006
India |
| Phone |
7888605632 |
| Fax |
|
| Email |
shivam.as499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Pratap |
| Designation |
Professor |
| Affiliation |
Central Institute of Psychiatry, Ranchi |
| Address |
Consultant Room, K.S. Mani CCN lab, Central institute Of psychiatry, Kanke, Ranchi, Jharkhand, India
Ranchi
JHARKHAND
834006
India |
| Phone |
7781803812 |
| Fax |
|
| Email |
dralokpratap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alok Pratap |
| Designation |
Professor |
| Affiliation |
Central Institute of Psychiatry, Ranchi |
| Address |
Consultant Room, K.S. Mani CCN lab, Central institute Of psychiatry, Kanke, Ranchi, Jharkhand, India
Ranchi
JHARKHAND
834006
India |
| Phone |
7781803812 |
| Fax |
|
| Email |
dralokpratap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry,Ranchi 834006 , Jharkhand, India |
|
|
Primary Sponsor
|
| Name |
Central Institute Of Psychiatry, Ranchi |
| Address |
Central Institute Of Psychiatry, Ranchi, Jharkhand, India, Pin: 834006 |
| 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 Arashdeep Singh |
Central Institute of Psychiatry |
Central
Institute of Psychiatry,
Kanke, Ranchi
Ranchi 834006
JHARKHAND
Ranchi
JHARKHAND |
7888605633
shivam.as499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, CIP ranchi |
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 |
OAT + Adjunctive Cannabidiol, Active |
Group 1 receiving-800mg CBD +
Buprenorphine (2mg) + T. Naloxone
(0.5mg) as OAT at day1, day2 and day 3 and Final rating of scales on day 10.
|
| Comparator Agent |
OAT only, control group |
Group 2 receiving- T.
Buprenorphine (2mg) + T.
Naloxone (0.5mg) as OAT, at day1,
day2 and day 3. and Final rating of scales on day 10.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with opioid dependence, current use (6C43.20) in ICD-11.
Male and females
Age : 18-60 year
Ability to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Patient dependent on any other psychoactive drugs other than nicotine and caffeine.
Diagnosis of any Axis I psychiatric condition.
Significant medical history or hypersensitivity to cannabinoids.
Significant medical or neurological illness including severe cardiovascular, hepatic, renal,
anaemia, history of severe head injury or myopathy or untreated thyroid disease.
Not willing to give written informed consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the reduction in opioid craving in patients with opioid dependence at baseline, after first between the patients receiving
adjunctive CBD and T. Buprenorphine (2mg) + T. Naloxone (0.5mg) as OAT (Opioid Agonist Therapy),
Vs patents receiving T. Buprenorphine (2mg) + T. Naloxone (0.5mg). |
primary outcomes are assessed at baseline, day1 ,day2,day3,and on day10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the decline in opioid withdrawal symptoms manifested in patients with opioid dependence
at baseline, post first dose (day 1), second dose (day 2), and third dose (day 3) of CBD and on day 10
among patients receiving adjunctive CBD and T. Buprenorphine 2mg + T. Naloxone (0.5mg) as OAT
(Opioid Agonist Therapy), Vs patents receiving T. Buprenorphine (2mg) + T. Naloxone (0.5mg). |
secondary outcomes are assessed at baseline, day1 ,day2,day3,and on day10 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
21/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Short-term, hospital-based, open-label comparative study designed to assess the effectiveness and safety of adding Cannabidiol (CBD) to standard Opioid Agonist Treatment (OAT) in reducing craving, withdrawal symptoms, and anxiety in individuals with opioid dependence. The study aims to recruit 70 male patients (aged 18-60) diagnosed with Opioid Dependence (ICD-11: 6C43.20). These participants will be randomized into two groups for the 10-day study period: Group 1 (n=35) receiving 800mg CBD plus OAT (T. Buprenorphine 2 mg + T. Naloxone 0.5 mg), and Group 2 (n=35) receiving OAT alone.The core objectives are to compare the reduction in opioid craving, withdrawal symptoms, and anxiety levels between the two groups at five specific time points: baseline, 2 hours post-dose on Day 1, Day 2, Day 3, and on Day 10. A comprehensive set of validated scales will be used for measurement: craving will be assessed by the Heroin Craving Questionnaire-Short Form 14 (HCQ-SF-14), Desire for Drug Questionnaire (DDQ), and Obsessive Compulsive Drug Use Scale (OCDUS); withdrawal severity will be tracked with the Clinical Opioid Withdrawal Scale (COWS); and anxiety will be quantified using the Hamilton Anxiety Rating Scale (HAM-A). The Systematic Assessment for Treatment Emergent Events (SAFTEE) will also be employed to monitor side effects. This research is significant as it seeks to provide formal clinical evidence for CBD in the context of the unique treatment challenges and high prevalence of opioid use in India. |