Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

PHASE1CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

May 15, 2017

Primary Completion Date

January 17, 2019

Study Completion Date

January 17, 2019

Conditions
Nicotine AddictionSerious Mental Illness
Interventions
DEVICE

Learn to Quit App

A smartphone app designed for individuals with serious mental illness. The main intervention components of the app are skills based on an intervention called Acceptance and Commitment Therapy that will (a) teach smoking cessation skills and (b) help cope with mental health symptoms. The app incorporates gaming features to keep users engaged, and a tracking component to record smoking habits and moods.

DRUG

Nicotine patch

Participants enrolled in the study will be given an 8-week course of Nicotine patches. The 8-week course of trans-dermal nicotine patches starting at 21mg/24h for 4 weeks, then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the last 2 weeks. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.

DRUG

Nicotine lozenge

Each participant will be given a 1-week course of 4mg Nicotine lozenges to be taken orally as nicotine cravings arise (about 10 lozenges per day). They will be directed to use them for the week following their quit date, using no more than once every 1-2 hours. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.

BEHAVIORAL

Technical Coaching

Coaching to assist the user on the use of each assigned smartphone app. This coaching will be delivered by research staff following a coaching procedure. These in-person coaching meetings will be brief (\~15 minutes), done on a weekly basis for 4 weeks, and will have a focus on providing technical assistance.

DEVICE

NCI QuitGuide App

A smartphone app developed by the National Cancer Institute which uses recommendations contained in the US DHHS Clinical Practice Guidelines and smokefree.gov. NCI QuitGuide has the following intervention components: (a) psycho-education about the impact of smoking in health, (b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies).

Trial Locations (1)

27705

Duke University, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Duke University

OTHER