Back to resultsText Message Support to Prevent Smoking Relapse
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message Craving Program
Self-Help Manual Plus Control Texts
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Current daily smoking defined as smoking ≥5 cigarettes per day and having smoked for at least 3 months. During the first visit smoking status will be verified by a Carbon Monoxide level of at least 8 parts per million.
- Have a mobile phone and use text messaging at least monthly
- Be planning to quit smoking without pharmacological help.
Exclusion Criteria:
- Significant cognitive impairment
- Current therapy or pharmacological intervention for smoking or nicotine cravings
- Inability to read English
Sites / Locations
- Miami University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Text Message Craving Program
Self-Help Manual Plus Control Texts
Arm Description
Text messages designed to help smokers to modify their thinking styles to be more adaptive, delivered 2-3 times per day.
A print, self-help manual plus general motivational text messages delivered 2-3 times per day.
Outcomes
Primary Outcome Measures
7-Day Point Prevalence Abstinence
Point prevalence abstinence is defined as the prevalence of not experiencing a full relapse in the period immediately preceding measurement. A full relapse will be defined as 7 continuous days of smoking or smoking ≥ 1 day(s) per week for the two consecutive weeks preceding the time of measurement. Self-reported abstinence will be verified by a Carbon Monoxide assay of breath samples and will override self-report in the direction of smoking.
Secondary Outcome Measures
Full Information
NCT ID
NCT02968095
First Posted
November 15, 2016
Last Updated
November 13, 2019
Sponsor
Miami University
Collaborators
National Institute on Drug Abuse (NIDA), University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT02968095
Brief Title
Text Message Support to Prevent Smoking Relapse
Official Title
Text Message Support to Prevent Smoking Relapse in Community Treatment Settings
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
August 23, 2019 (Actual)
Study Completion Date
August 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Miami University
Collaborators
National Institute on Drug Abuse (NIDA), University of Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to test a text message intervention for people who are beginning an attempt to quit smoking. The intervention seeks to teach people to think about their cravings to smoke in more helpful ways. The investigators expect that participants receiving the text message craving program will be less likely to begin smoking again compared to participants in a control condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Text Message Craving Program
Arm Type
Experimental
Arm Description
Text messages designed to help smokers to modify their thinking styles to be more adaptive, delivered 2-3 times per day.
Arm Title
Self-Help Manual Plus Control Texts
Arm Type
Active Comparator
Arm Description
A print, self-help manual plus general motivational text messages delivered 2-3 times per day.
Intervention Type
Behavioral
Intervention Name(s)
Text Message Craving Program
Intervention Description
Text messages targeting cravings delivered 2-3 times per day.
Intervention Type
Behavioral
Intervention Name(s)
Self-Help Manual Plus Control Texts
Intervention Description
Self-help manual plus motivational text messages delivered 2-3 times per day.
Primary Outcome Measure Information:
Title
7-Day Point Prevalence Abstinence
Description
Point prevalence abstinence is defined as the prevalence of not experiencing a full relapse in the period immediately preceding measurement. A full relapse will be defined as 7 continuous days of smoking or smoking ≥ 1 day(s) per week for the two consecutive weeks preceding the time of measurement. Self-reported abstinence will be verified by a Carbon Monoxide assay of breath samples and will override self-report in the direction of smoking.
Time Frame
End of Treatment (6-week) Follow-Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Current daily smoking defined as smoking ≥5 cigarettes per day and having smoked for at least 3 months. During the first visit smoking status will be verified by a Carbon Monoxide level of at least 8 parts per million.
Have a mobile phone and use text messaging at least monthly
Be planning to quit smoking without pharmacological help.
Exclusion Criteria:
Significant cognitive impairment
Current therapy or pharmacological intervention for smoking or nicotine cravings
Inability to read English
Facility Information:
Facility Name
Miami University
City
Oxford
State/Province
Ohio
ZIP/Postal Code
45056
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Text Message Support to Prevent Smoking Relapse
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