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Development of a mHealth Intervention for Ambivalent Smokers

Kaiser Permanente logo

Kaiser Permanente

Status and phase

Completed
Phase 1

Conditions

Motivation
Tobacco Use Disorder
Smoking Cessation
Behavior, Smoking

Treatments

Device: Experimental mHealth program
Device: Control mHealth program
Drug: Nicotine patch

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04560868
1401452
R21CA234003 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18 years or older;
  • Can speak/read English;
  • Current smoker;
  • Own and regularly use an eligible smartphone;
  • No vision impairments;
  • Willing to install and use the study program;
  • Willing to use birth control if elect to use nicotine replacement during the study (females);
  • Meet definition for ambivalence
  • Not actively using treatment

Exclusion criteria

  • Smoke less than 10 cigarettes per day
  • Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia;
  • Have medical contraindications for nicotine replacement therapy;
  • Another household member is enrolled in the study
  • Unable to verify contact information
  • Fail to install app

Trial design

Primary purpose

Device Feasibility

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

57 participants in 2 patient groups

Control
Active Comparator group
Treatment:
Device: Control mHealth program
Drug: Nicotine patch
Experimental
Experimental group
Treatment:
Device: Experimental mHealth program
Drug: Nicotine patch

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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