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Completed

NCT Number: NCT04020718

Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.

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Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massacusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥18 years)
  • Smoking status of current smoker in structured field of electronic health record (EHR)
  • Language listed as English in EHR
  • Massachusetts General Hospital patient, Partners healthcare primary care provider (PCP)
  • PCP visit in the past 2 years
  • Mobile telephone number listed in EHR

Exclusion criteria

  • Not a current daily smoker defined as not having smoked ≥100 cigarettes in lifetime or self-report of less than daily current smoking
  • Pregnant, planning to become pregnant in the next 3 months, or breastfeeding.
  • Past 30-day use of nicotine replacement therapy, bupropion, or varenicline.
  • Past 30-day use of Massachusetts state quit-line or SmokefreeTXT programs
  • Prior serious adverse reaction to the nicotine patch or lozenge defined as any reaction that was life-threatening, required hospitalization, or other clinical evaluation
  • Ever had an allergy to nicotine patch
  • Weight < 100 pounds
  • Unstable coronary disease
  • Unstable arrhythmia
  • Dementia or active psychosis or schizoaffective disorder
  • Willing and able to receive and participate with a text message program for up to 12 weeks
  • Unable to read English or unable to write English

Treatment and study plan

Brief telephone advice plus tailored text messages

Behavioral

All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit and quit date. Content is personalized with user's name and Massachusetts General Hospital resources.

Mailed nicotine replacement therapy

Drug

Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette).

Proactive telephone coaching

Behavioral

Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.

Primary outcomes

  1. Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks

    Time frame: 12 weeks post-randomization

    7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"

Secondary outcomes

  1. Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks

    Time frame: 8 weeks post-randomization

    7-day point prevalence abstinence (0, abstinent; 1, smoking)

  2. Exhaled Carbon Monoxide Less Than 8 Parts Per Million

    Time frame: 12 weeks post-randomization

    Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment

  3. Self-reported Number of Days Nicotine Lozenge and/or Patch Used

    Time frame: 12 weeks post-randomization

    Number of days when patch and/or lozenge was used

  4. Self-reported Change in Average Number of Cigarettes Smoked Per Day

    Time frame: 12 weeks post-randomization

    Self-reported change in average cigarettes smoked per day

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 16, 2019
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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