Skip to content

Comparison of effectiveness of Bupropion and Nicotine gum for smokers dependent on Opioids

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 - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067468
Enrollment
100
Registered
2024-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F172- Nicotine dependence

Interventions

Intervention1: 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 Contro

Sponsors

National Drug Dependent Treatment Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
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) Timepoint: 1 month and 3 months

Secondary

MeasureTime frame
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 Timepoint: 1 month and 3 months

Countries

India

Contacts

Public ContactDr Sonali Jhanjee

National Drug Dependence Treatment Centre

sonali_arj@hotmail.com911126594997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026