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Clinical Trials/CTRI/2024/05/067200
CTRI/2024/05/067200Active, not recruitingNot Applicable

Efficacy of nurse delivered brief interventions for tobacco use disorders: A multispecialty open label randomized control trial

Indian Council of Medical Research1 site in 1 country550 target enrollmentStarted: May 21, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
550
Locations
1
Primary Endpoint
Proportion of patients abstinent after intervention (as measured by negative urine cotinine levels)

Study Overview

Brief Summary

Background: Treatment gap for tobacco use disorders is as high as 92%. Training nursing professionals to deliver brief interventions can help is reducing the treatment gap. Evidence for efficacy of such interventions is absent in Indian context.

Novelty: Generating evidence for nurse delivered brief interventions for tobacco use disorders in Indian context will have public health implications.

Objective: The primary objective is to compare the abstinent rates between two groups. The secondary objective is to compare the reduction in tobacco use between the groups and also, to compare the abstinence rates and reduction in the tobacco use among the individual specialties for smokeless and smoking tobacco.

Methods: A prospective, open label, parallel arm, randomized clinical trial in patients with tobacco use disorder attending the OPD of the AIIMS Deoghar in all the participating departments of this study (6 departments), over a period of 24 months. 550 patients with tobacco use disorders, who are currently either smoking or using smokeless tobacco in the last 1 week and fulfilling the inclusion and exclusion criterion will be recruited for the study. Participants will be randomized into group 1 (treatment as usual) and group 2 (treatment as usual with nurse delivered brief intervention). Tobacco use patterns, craving, motivation to quit, urine cotinine level will be assessed at baseline and 4 weeks.

Expected outcome: We expect that proportion of patients abstinent (as measured by negative urine cotinine levels) will be higher among the participants receiving the nurse delivered brief intervention group compared to treatment as usual only group.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients clinically diagnosed with tobacco use disorders according to DSM-5 (19).
  • Patients aged 18-60 years of either sex.
  • Patients who are current tobacco users (using once in last 1 week).
  • Patients giving voluntary written consent for participation.

Exclusion Criteria

  • Presence of comorbid other substance use disorder in dependence pattern.
  • Critically ill patients or patients in acute emergency
  • Patients already on treatment for tobacco use disorders.

Outcomes

Primary Outcomes

Proportion of patients abstinent after intervention (as measured by negative urine cotinine levels)

Time Frame: Baseline & 28th Day

Secondary Outcomes

  • • Proportion of patients reduced tobacco use after intervention(• Proportion of abstinent or reduced tobacco in each specialty)

Investigators

Sponsor Class
Government funding agency
Responsible Party
Principal Investigator
Principal Investigator

Santanu Nath

All India Institute of Medical Sciences- Deoghar

Study Sites (1)

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