NCT02968095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1.7 years until next milestone

Study Start

First participant enrolled

August 7, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

November 15, 2016

Last Update Submit

November 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Text Message Craving Program

EXPERIMENTAL

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

Self-Help Manual Plus Control Texts

ACTIVE COMPARATOR

A print, self-help manual plus general motivational text messages delivered 2-3 times per day.

Behavioral: Self-Help Manual Plus Control Texts

Interventions

Text messages targeting cravings delivered 2-3 times per day.

Text Message Craving Program

Self-help manual plus motivational text messages delivered 2-3 times per day.

Self-Help Manual Plus Control Texts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Significant cognitive impairment
  • Current therapy or pharmacological intervention for smoking or nicotine cravings
  • Inability to read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami University

Oxford, Ohio, 45056, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 18, 2016

Study Start

August 7, 2018

Primary Completion

August 23, 2019

Study Completion

August 23, 2019

Last Updated

November 15, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations