NCT03837379

Goal2Quit + NRT Sampling

Completed NA Results posted Last updated 17 May 2023

What this trial tests

NA trial testing Treatment as Usual in Cigarette Smoking in 164 participants. Completed in 18 May 2022.

Timeline

22 June 2020

Primary endpoint
18 May 2022

18 May 2022

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	164
Start date	22 June 2020
Primary completion	18 May 2022
Estimated completion	18 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Treatment as Usual
• Goal2Quit + NRT Sampling

Conditions studied

• Cigarette Smoking — all drugs for Cigarette Smoking →
• Smoking Cessation — all drugs for Smoking Cessation →
• Depression — all drugs for Depression →

Sponsor

Medical University of South Carolina

Who can join

18 and older, any sex, with Cigarette Smoking or Smoking Cessation. 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.

7 Day Point Prevalence Abstinence Primary · From 7 days preceding the 12-week follow-up assessment through the 12-week follow-up assessment.

Patients will self report smoking status (yes/no) for the seven days preceding the 12-week follow-up assessment. The data reported is based on the participants that reported yes.

Group	Value	95% CI
Treatment As Usual	1
Goal2Quit + NRT Sampling	16

Mean Score of Depressive Symptoms Secondary · Change in BDI from baseline to Week 12

Patients will self report depressive symptoms weekly for 8 weeks with final follow-up at 12-weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression.

Group	Value	95% CI
Treatment As Usual	-6.97	± 11.15
Goal2Quit + NRT Sampling	-9.06	± 11.60

Sponsor's own description

The goal of this work is to develop, systematically evaluate, and clinically test an integrated cessation intervention comprised of a depression-specific Behavioral Activation (BA) for cessation mobile app ("Goal2Quit") packaged with nicotine replacement therapy (NRT) sampling. This integrated intervention will address the need for an easily disseminable, evidence-based, depression-specific cessation intervention for delivery via primary care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Behavioral Activation-Based Digital Smoking Cessation Intervention for Individuals With Depressive Symptoms: Randomized Clinical Trial.
   Dahne J, Wahlquist AE, Kustanowitz J, Natale N, et al · · 2023 · cited 11× · PMID 37910157 · DOI 10.2196/49809