Health Condition 1: F172- Nicotine dependence
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Males aged 18 years and above (2) Tobacco users with alcohol dependence (ICD-10 diagnosis) (3) Willingness to participate and give informed consent
Exclusion criteria
Exclusion criteria: 1.Severe psychiatric illness (e.g., psychosis, severe depression with suicidality, bipolar disorder) 2.Serious systemic illness (e.g., decompensated liver disease, uncontrolled hypertension, cardiovascular instability, severe COPD/asthma) 3.Women (pregnant or non-pregnant) 4.Individuals currently enrolled in another cessation program or clinical trial 5.Cognitively impaired individuals unable to understand study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess and compare the change in tobacco use in: oGroup A: receiving pharmacotherapy and psychotherapy for 8 weeks oGroup B: receiving pharmacotherapy with 3i Vethathirian Talkless Therapy (first 4 weeks) followed by psychotherapy (next 4 weeks) 2.To verify behavioural outcomes using biochemical markers: oUrinary/salivary cotinine strips for tobacco cessation oCO breath analyser for smoking status ouEtG (Urinary Ethyl Glucuronide) strips for alcohol abstinence 3.To evaluate withdrawal symptoms using the CIWA-Ar scale and compare symptom reduction between the groups at Week 4 and Week 8. Timepoint: At the end of 4th, 8th and 12 th weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To examine the additive effect of staged intervention (3i followed by psychotherapy) on: o Motivation for abstinence o Emotional regulation o Craving reduction 2. To evaluate participant adherence and acceptability of the two-phase protocol. 3. To determine the feasibility of integrating 3i Talk-less Therapy as an alternative / adjunct to standard care in addiction rehabilitation settings. Timepoint: End of 4th, 8th and 12th Weeks | — |
Countries
India
Contacts
JKKN Dental College & Hospital