Text Message Support to Prevent Smoking Relapse

Text Message Support to Prevent Smoking Relapse in Community Treatment Settings

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Behavioral: Text Message Craving Program; Behavioral: Self-Help Manual Plus Control Texts

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Oxford, Ohio, United States, 45056
      • Miami University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text Message Craving Program; Text messages designed to help smokers to modify their thinking styles to be more adaptive, delivered 2-3 times per day.	Behavioral: Text Message Craving Program; Text messages targeting cravings delivered 2-3 times per day.
Active Comparator: Self-Help Manual Plus Control Texts; A print, self-help manual plus general motivational text messages delivered 2-3 times per day.	Behavioral: Self-Help Manual Plus Control Texts; Self-help manual plus motivational text messages delivered 2-3 times per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	End of Treatment (6-week) Follow-Up

Collaborators and Investigators

• Sponsor: Miami University
• Collaborators: National Institute on Drug Abuse (NIDA); University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Actual): August 23, 2019
• Study Completion (Actual): August 23, 2019

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: K23DA037320 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No