Goal2Quit + NRT Sampling

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Cigarette Smoking; Depression; Smoking Cessation

Treatments: Behavioral: Treatment as Usual; Combination Product: Goal2Quit + NRT Sampling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03837379

K23DA045766 (U.S. NIH Grant/Contract)

00074015

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current elevated depressive symptoms defined as a score of > 10 (at least mild depression) on the Patient Health Questionnaire-8 (PHQ-8)
• Current smoking, defined as smoking 10+ cigarettes/day, for 25+ days out of the last 30, for the last 6+ months
• Ownership of an Android or iOS smartphone
• Age 18+
• Possess a valid e-mail address that is checked daily to access follow-up assessments
• English fluency

Exclusion criteria

• Contraindications for NRT (pregnancy/intention to become pregnant/breastfeeding, recent cardiovascular trauma/uncontrolled hypertension) - Severe visual impairment, which may limit ability to utilize an app

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

164 participants in 2 patient groups

Treatment As Usual

Other group

Description:

Participants in the Treatment As Usual condition will receive educational material on quitting smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.

Treatment:

Behavioral: Treatment as Usual

Goal2Quit + NRT Sampling

Experimental group

Description:

Participants in the Goal2Quit + NRT Sampling condition will receive a download code to download the Goal2Quit mobile application. Goal2Quit is a mobile app for cigarette smokers with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, rate mood daily, and track cigarette smoking. Participants in Group B will also receive a two-week "starter kit" sample of nicotine replacement therapy (NRT; 14mg patch and 4mg lozenge). Participants will be asked to utilize Goal2Quit regularly, at least once per day, as well as the NRT sample in an attempt to quit smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.

Treatment:

Combination Product: Goal2Quit + NRT Sampling