NCT03620708

Tobacco and Socioeconomic Disadvantage

Completed Phase 4 Results posted Last updated 15 November 2019

What this trial tests

Phase 4 trial testing Motivational Interviewing in Tobacco Smoking in 58 participants. Completed in 1 October 2018.

Timeline

30 May 2018

Primary endpoint
1 October 2018

1 October 2018

Quick facts

Lead sponsor	Rutgers, The State University of New Jersey
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	58
Start date	30 May 2018
Primary completion	1 October 2018
Estimated completion	1 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Motivational Interviewing
• Nicotine Replacement Therapy Sampling — full drug profile →
• Referral Only

Conditions studied

• Tobacco Smoking — all drugs for Tobacco Smoking →

Sponsor

Rutgers, The State University of New Jersey

Who can join

Adults 18 to 65, any sex, with Tobacco Smoking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire' Primary · 30 days

A self-described "serious" attempt to quit smoking cigarettes since the initial study appointment, measured by the "Quitting Preparation and Actions Questionnaire."

Group	Value	95% CI
Motivational Interviewing	5
Nicotine Replacement Therapy Sampling	10
Referral Only	6

Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire' Primary · 30 days

Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment

Group	Value	95% CI
Motivational Interviewing	0
Nicotine Replacement Therapy Sampling	1
Referral Only	3

Self-reported Cigarettes Per Day Secondary · 30 days

Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide \< 5ppm

Group	Value	95% CI
Motivational Interviewing	13.0	± 7.1
Nicotine Replacement Therapy Sampling	7.6	± 6.3
Referral Only	10.3	± 6.9

Importance, Confidence, & Readiness Questionnaire Secondary · 30 days

Motivation and Self-efficacy for quitting smoking measured via Importance, Confidence, \& Readiness Questionnaire" (rated on a 0 to 10 scale with higher numbers indicating greater importance, confidence, or readiness to quit)

Confidence in ability to quit (0-10)

Group	Value	95% CI
Motivational Interviewing	4.8	± 2.8
Nicotine Replacement Therapy Sampling	5.5	± 3.2
Referral Only	6.5	± 2.8

Importance of Quitting (0-10)

Group	Value	95% CI
Motivational Interviewing	7.6	± 2.9
Nicotine Replacement Therapy Sampling	7.3	± 3.4
Referral Only	8.1	± 3.0

Readiness to Quit (0-10)

Group	Value	95% CI
Motivational Interviewing	3.8	± 3.1
Nicotine Replacement Therapy Sampling	5.1	± 3.2
Referral Only	5.6	± 3.0

Readiness to Quit Ladder Secondary · 30 days

"Readiness to Quit Ladder" (with 10 non-numbered choices, ranging from 0 to 10 reflecting varying degrees of readiness to quit smoking; higher numbers reflect greater readiness to quit smoking)

Group	Value	95% CI
Motivational Interviewing	5.7	± 1.3
Nicotine Replacement Therapy Sampling	6.6	± 2.1
Referral Only	6.4	± 2.0

Sponsor's own description

Randomized clinical trial comparing 3 brief interventions designed to increase motivation to quit smoking in socioeconomically disadvantaged smokers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.