Smoking Cessation Clinical Trial
— GR2QOfficial title:
A Text Messaging Intervention for Smoking Cessation Among Community Health Center Patients
Verified date | January 2020 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a four arm pilot randomized controlled trial testing the effect of a 12 week
text messaging intervention and a mailed nicotine medication intervention, alone and in
combination to a control condition consisting of brief behavioral advice and usual care.
Research Aim 1: To test, in a 4 arm pilot randomized controlled trial (N=50/group), the
effect of a text messaging program and mailed nicotine replacement therapy on smoking
outcomes and medication use.
Hypothesis 1: A text messaging intervention will increase the proportion of smokers making a
quit attempt compared to smokers receiving no text messaging.
Hypothesis 2: A text messaging intervention will increase adherence to nicotine replacement
therapy compared to subjects receiving only 2 weeks of nicotine replacement therapy.
Hypothesis 3: A text messaging intervention will increase the rate of biochemically confirmed
past 7-day point prevalent tobacco abstinence at end of treatment compared to subjects
receiving no text messaging intervention.
Hypothesis 4: A text messaging intervention will increase the number of days not smoking
compared to subjects receiving no text messaging intervention.
Hypothesis 5: A text messaging intervention will decrease the number of cigarettes smoked per
day compared to subjects receiving no text messaging intervention.
Status | Completed |
Enrollment | 153 |
Est. completion date | February 28, 2019 |
Est. primary completion date | January 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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, "QuitWorks" 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 affecting ability to consent - Willing and able to receive and participate with a text message program for up to 12 weeks |
Country | Name | City | State |
---|---|---|---|
United States | Massacusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quit Attempts | Self-reported quit attempt in the last 12 weeks defined as intentional not smoking for 24 hours or more ("During the past 12 weeks, have you quit smoking intentionally for 1 day or longer"). | End of treatment (12 week post-enrollment) | |
Secondary | 7 Day Point Prevalent Abstinence | Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?" | 6 weeks post-enrollment | |
Secondary | 7 Day Point Prevalent Abstinence | Self-reported abstinence "Have you smoked, even a puff, in the past 7 days?" | 12 weeks post-enrollment (end of treatment) | |
Secondary | Milligrams of Nicotine Medication Used | Self-reported milligrams of nicotine medication used | week 2 post enrollment | |
Secondary | Percentage of Days Not Smoked | Self-reported, "In the past 30 days, how many days did you have at least one cigarette?" | 12 weeks post-enrollment (end of treatment) | |
Secondary | Exhaled Carbon Monoxide | Exhaled carbon monoxide measured among self-reported quitters less than or equal to 9 parts per million | 12 weeks post-enrollment (end of treatment) | |
Secondary | Days Nicotine Medication Used | Self-reported number of days nicotine lozenge and/or patch used | Total reported over 2 weeks post-enrollment | |
Secondary | Milligrams Nicotine Medication Used | Self-reported number of milligrams nicotine medication used | Total reported over 1 week post-enrollment | |
Secondary | Change in Cigarettes Per Day | Self-reported number of cigarettes per day on days smoked, change | 12 weeks post enrollment (end of treatment) |
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