Tobacco Use DisorderNCT02968095
Text Message Support to Prevent Smoking Relapse
A study testing Text Message Craving Program in people with Tobacco Use Disorder, run by Miami University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Text Message Craving Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 23 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Significant cognitive impairment
- Current therapy or pharmacological intervention for smoking or nicotine cravings
- Inability to read English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Text Message Craving Program, Self-Help Manual Plus Control Texts
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message Craving ProgramBehavioural
Text messages targeting cravings delivered 2-3 times per day.
Self-Help Manual Plus Control TextsBehavioural
Self-help manual plus motivational text messages delivered 2-3 times per day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-Help Manual Plus Control Texts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of Treatment (6-week) Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start7 Aug 2018
- Primary completion23 Aug 2019
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Cincinnati
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968095
- Sponsor's protocol ID
- K23DA037320
- Other IDs
- K23DA037320
- Status last verified
- Nov 2019
- First submitted
- 15 Nov 2016
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Message Support to Prevent Smoking Relapse in Community Treatment Settings
- ClinicalTrials.gov ID
- NCT02968095
- Acronym / sponsor ID
- K23DA037320
- Conditions
- Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Miami UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Cincinnati
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Message Craving Program | Experimental | Behavioral: Text Message Craving ProgramText messages designed to help smokers to modify their thinking styles to be more adaptive, delivered 2-3 times per day. |
| Self-Help Manual Plus Control Texts | Active comparator | Behavioral: Self-Help Manual Plus Control TextsA print, self-help manual plus general motivational text messages delivered 2-3 times per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Significant cognitive impairment
- Current therapy or pharmacological intervention for smoking or nicotine cravings
- Inability to read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Message Craving ProgramText messages targeting cravings delivered 2-3 times per day. | Behavioural | Text Message Craving Program |
| Self-Help Manual Plus Control TextsSelf-help manual plus motivational text messages delivered 2-3 times per day. | Behavioural | Self-Help Manual Plus Control Texts |
Primary outcome
7-Day Point Prevalence Abstinence
Time frame: End of Treatment (6-week) Follow-Up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message Craving Program in people with Tobacco Use Disorder, run by Miami University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Day Point Prevalence Abstinence (time frame: End of Treatment (6-week) Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.