COMPARISON OF EFFICACY OF 4MG NICOTINE GUM AND 4MG NICOTINE LOZENGES IN REDUCTION OF TOBACCO CRAVING, WITHDRAWAL SYMPTOMS AND TOBACCO SELF CONTROL RATE AMONG SMOKELESS TOBACCO CHEWERS AGED 20 â?? 35 YEARS IN DAVANGERE â?? A CONCURRENT PARALLEL RANDOMISED CONTROLLED TRIAL.

COMPARISON OF EFFICACY OF 4MG NICOTINE GUM AND 4MG NICOTINE LOZENGES IN REDUCTION OF CRAVING, WITHDRAWAL SYMPTOMS AND TOBACCO ABSTINENCE RATE AMONG SMOKELESS TOBACCO USERS AGED 20 â?? 35 YEARS IN DAVANGERE â?? A CONCURRENT PARALLEL RANDOMISED CONTROLLED TRIAL.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032000

Enrollment

Registered

2021-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: NICOTINE GUM: 4MG NICOTINE GUM ON SMOKELSS TOBACCO USERS ORAL ROUTE OF ADMINISTRATION FOR 3 MONTHS Control Intervention1: NICOTINE LOZENGE: 4MG NICOTINE LOZENGE ON SMOKELESS TOBACCO USE

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects who will give voluntary written informed consent. 2. Subjects who consume smokeless tobacco in form of pan masala with tobacco (Vimal, G S T, siddhu) and gutka (Star, RMD, Pan Parag). 3. Subjects with a nicotine dependency score of 7 and above will be included. 4. Subjects who never made any quit attempts using nicotine replacement therapy, behavioural therapy or pharmacotherapy. 5. Subjects belong to 20-35 years of age, in good general health. 6. Subjects who are willing to quit the smokeless tobacco habit. 7. Subjects whose salivary thiocyanate nicotine level ranges 6mM will be included.

Exclusion criteria

Exclusion criteria: 1. Subjects who are known to have systemic conditions and diseases such as hypertension, diabetes mellitus, tuberculosis, cancer, cardiovascular diseases, blood disorders. 2. Subjects who are under medication like corticosteroids, anti-retroviral drugs, anti-histamines, anti-asthmatic drugs. 3. Subjects who are Pregnant or lactating. 4. Subjects who had undergone any surgeries like coronary angioplasty in the past 3 months. 5. Subjects have history of smoking, alcohol consumption and other substances like heroin, marijuana, cannabis, benzodiazepines, opioids.

Design outcomes

Secondary

Measure	Time frame
TOBACCO ABSTINENCE RATETimepoint: 12TH WEEK	—

Primary

Measure	Time frame
CRAVING AND WITHDRAWAL SYMPTOMSTimepoint: CRAVING AND WITHDRAWAL SYMPTOMS AT BASELINE FIRST WEEK, SEVENTH WEEK, TENTH WEEK AND TWELVETH WEEK	—

Countries

India

Contacts

Public ContactDR UMBRANIKAR MANJUSHA

BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE

drushe8@yahoo.in7829794198

Outcome results