| CTRI Number |
CTRI/2024/05/067468 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of Bupropion and Nicotine gum for smokers dependent on Opioids |
|
Scientific Title of Study
|
Effectiveness of Nicotine Replacement Therapy (NRT) and Bupropion for Smoking Cessation amongst opioid dependent subjects on agonist maintenance treatment: A Randomized Open-Label, Parallel-Group Trial |
| 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 Muhammed Jadeer K |
| Designation |
DM Addiction Psychiatry resident |
| Affiliation |
National Drug Dependence Treatment Centre |
| Address |
National Drug Dependence
Treatment Centre, Kamla
Nehru Nagar,
Ghaziabad, Uttar Pradesh, 201002
Ghaziabad
UTTAR PRADESH
201002
India |
| Phone |
9968968753 |
| Fax |
|
| Email |
jadeerpnr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Jhanjee |
| Designation |
Professor of Psychiatry |
| Affiliation |
National Drug Dependence Treatment Centre |
| Address |
Room No 4090, 4th Floor, Teaching Block,
All India Institute of Medical Sciences (AIIMS),
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
911126594997 |
| Fax |
|
| Email |
sonali_arj@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Jhanjee |
| Designation |
Professor of Psychiatry |
| Affiliation |
National Drug Dependence Treatment Centre |
| Address |
Room No 4090, 4th Floor, Teaching Block,
All India Institute of Medical Sciences (AIIMS),
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
911126594997 |
| Fax |
|
| Email |
sonali_arj@hotmail.com |
|
|
Source of Monetary or Material Support
|
| National Drug Dependence
Treatment Centre, Kamla Nehru Nagar,
Ghaziabad,
Uttar Pradesh,
201002
India |
|
|
Primary Sponsor
|
| Name |
National Drug Dependent Treatment Centre |
| Address |
National Drug Dependence
Treatment Centre, Kamla Nehru Nagar,
Ghaziabad,
Uttar Pradesh,
201002,
India |
| 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 Muhammed Jadeer K |
National Drug Dependence Treatment Center, Gaziabad |
National Drug Dependence
Treatment Centre, Outpatient Department, Room number 106/107/110 or 111
Kamla Nehru Nagar,
Ghaziabad,
Uttar Pradesh,
201002,
India
Ghaziabad
UTTAR PRADESH |
9968968753
jadeerpnr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institue Ethics Committee For Postgraduate Research, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupropion |
150mg-300mg, daily, oral route,
for 9 weeks |
| Intervention |
Nicotine Gum |
Nicotine gum 2mg or 4mg
based on the amount of tobacco
use, Every 1-2 hours , Oromucosal
route(chew and keep between
the teeth and buccal mucosa),
for 10 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Age 18 to 60 years
Male
Current (last 1 month) user of tobacco by smoking route
Diagnosed with nicotine dependence, current use as per ICD-11 criteria
Currently following up in NDDTC OPD for Opioid agonist maintenance treatment (Buprenorphine-Naloxone) with 80% medication dispensing
Willing to participate in follow up at 4-6 weeks and 12-14 weeks
|
|
| ExclusionCriteria |
| Details |
History of co-morbid psychiatric illnesses (as per clinical interview)
Current (last 1 month)Dependence on drugs other than opioid and nicotine
Current users of smokeless tobacco
Has ever received tobacco cessation intervention (except simple advice from a health care professional) in the past 3 months
Unwilling to give informed consent
Contraindication for Nicotine replacement therapy (accelerated hypertension, post-myocardial infarction period (2 weeks), hypersensitivity to NRT) or Bupropion (Seizure episode, eating disorder)
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
i. Biochemically confirmed seven-day point prevalence abstinence at 1- and 3-month follow-up
ii. Reduction in smoking use as measured by self-reported amount of tobacco use(number of beedi or cigarettes)
|
1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Continuous abstinence from smoking at 1- and 3-month follow-up (Complete abstinence beginning on the target quit date till the date of assessment)
ii. Change in the stage of motivation
|
1 month and 3 months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
High smoking prevalence among opioid-dependent patients, coupled with
the associated comorbidity leading to elevated mortality rates, underscores
the urgent need for intensified efforts addressing tobacco use in this
population. The persistently low quit rates emphasize the critical gap in
research and intervention. Importantly, a significant proportion of these
patients express a willingness to quit tobacco, highlighting a potential
avenue for targeted support.
Bupropion and Nicotine replacement therapy are effective and first line
pharmacological management methods for tobacco cessation. Opioid
agonist maintenance treatment provides a unique opportunity to provide
comorbid tobacco dependence management. However, the effectiveness
of tobacco cessation strategies in the context of comorbid opioid
dependence syndrome remains inadequately studied, with only one known
study conducted in India, requiring the need for further research and
tailored interventions to effectively manage this condition |