Smoking CessationMI-SUDNCT01882673
Motivating Quitline Use Among Smokers in Treatment for Substance Use Disorders
A study testing Brief Computer Motivational Interviewing for Smoking Cessation in people with Smoking Cessation, run by Butler Hospital at 1 site in United States.
Trial summary
The long-term goal of this program of research is to disseminate an effective, brief computer-based intervention that can be readily integrated into Substance Use Disorders (SUD) treatment programs to motivate tobacco quitline use in patients who smoke. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Brief Computer Motivational Interviewing for Smoking Cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jul 2014
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18 and 70 years of age
- current smoker (i.e., at least 10 cigarettes per day)
- current DSM-IV alcohol or drug abuse or dependence per SCID-P.
Who cannot join
- history of psychotic disorder or current psychotic symptoms per the Structured Clinical Interview for DSM 4R - Patient version
- cognitive impair-ment sufficient to impair provision of informed consent or study participation
- current suicidality or homicidality
- use of NRT or other pharmacotherapy for smoking cessation
- use of other tobacco products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Computer Intervention to Motivate Quitline Use for Smokers in SUD Treatment
The long-term goal of this program of research is to disseminate an effective, brief computer-based intervention that can be readily integrated into Substance Use Disorders (SUD) treatment programs to motivate tobacco quitline use in patients who smoke. The overall objective of this application, which is the first step in the attainment of this long-term goal, is to fully develop this computer-based intervention, modify it based on initial piloting and feedback to insure its feasibility and acceptability, and obtain preliminary data supporting the efficacy of the intervention. This will be accomplished by pursuing three specific aims: 1) to develop and conduct preliminary pilot testing (n=20) of a brief, computer-based intervention intended to motivate tobacco quitline use among cigarette smokers in SUD treatment (TIME-TQ; Tablet computer Intervention to Motivate Engagement in Tobacco Quitline use) and to develop and pilot test a computer-based, time matched control intervention (CON), 2) to conduct a preliminary randomized controlled trial (RCT) with 60 smokers in SUD treatment, comparing TIME-TQ vs. CON, with predictions that TIME-TQ relative to CON will result in increased readiness, higher rates of tobacco treatment engagement, more quit smoking attempts and higher rates of 7-day point prevalence abstinence rates at 1- and 3-month follow-ups. Substance use outcomes over the course of the 3-month follow-up period will also be examined, and 3) to examine TIME-TQ's effects on key mechanisms during the computer session and their associations with tobacco treatment engagement and smoking outcomes at 1- and 3-month follow-ups.
- Conditions
- Smoking Cessation
- Being tested
- Brief Computer Motivational Interviewing for Smoking Cessation, Nutrition Control
- Keywords
- Tobacco, nicotine, dependence, quitline
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Computer Motivational Interviewing for Smoking CessationBehavioural
Brief computer motivational interviewing intervention to motivated tobacco quitline use
Nutrition ControlBehavioural
Computer delivered nutrition education control condition
| Study group | Role | What they receive |
|---|---|---|
| Brief Computer Motivational Interviewing for Smoking Cessation | Experimental | Brief computer motivational interviewing intervention to motivate tobacco quitline use Receives: Behavioral: Brief Computer Motivational Interviewing for Smoking Cessation |
| Nutrition Control | Active comparator | Computer delivered nutrition education Receives: Behavioral: Nutrition Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engaged in tobacco cessation treatment since end of treatment intervention
Measured: 3-months
Secondary outcomes (1)
Number of quit smoking attempts since last assessment
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard A. Brown, Ph.D., Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882673
- Sponsor's protocol ID
- DA034312
- Acronym
- MI-SUD
- Status last verified
- Jul 2016
- First submitted
- 10 Jun 2013
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Computer Intervention to Motivate Quitline Use for Smokers in SUD Treatment
- ClinicalTrials.gov ID
- NCT01882673
- Acronym / sponsor ID
- MI-SUD / DA034312
- Conditions
- Smoking Cessation
- Keywords
- Tobacco, nicotine, dependence, quitline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Jun 2013 (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 long-term goal of this program of research is to disseminate an effective, brief computer-based intervention that can be readily integrated into Substance Use Disorders (SUD) treatment programs to motivate tobacco quitline use in patients who smoke. The overall objective of this application, which is the first step in the attainment of this long-term goal, is to fully develop this computer-based intervention, modify it based on initial piloting and feedback to insure its feasibility and acceptability, and obtain preliminary data supporting the efficacy of the intervention. This will be accomplished by pursuing three specific aims: 1) to develop and conduct preliminary pilot testing (n=20) of a brief, computer-based intervention intended to motivate tobacco quitline use among cigarette smokers in SUD treatment (TIME-TQ; Tablet computer Intervention to Motivate Engagement in Tobacco Quitline use) and to develop and pilot test a computer-based, time matched control intervention (CON), 2) to conduct a preliminary randomized controlled trial (RCT) with 60 smokers in SUD treatment, comparing TIME-TQ vs. CON, with predictions that TIME-TQ relative to CON will result in increased readiness, higher rates of tobacco treatment engagement, more quit smoking attempts and higher rates of 7-day point prevalence abstinence rates at 1- and 3-month follow-ups. Substance use outcomes over the course of the 3-month follow-up period will also be examined, and 3) to examine TIME-TQ's effects on key mechanisms during the computer session and their associations with tobacco treatment engagement and smoking outcomes at 1- and 3-month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Computer Motivational Interviewing for Smoking Cessation | Experimental | Behavioral: Brief Computer Motivational Interviewing for Smoking CessationBrief computer motivational interviewing intervention to motivate tobacco quitline use |
| Nutrition Control | Active comparator | Behavioral: Nutrition ControlComputer delivered nutrition education |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 18 and 70 years of age
- current smoker (i.e., at least 10 cigarettes per day)
- current DSM-IV alcohol or drug abuse or dependence per SCID-P.
Key exclusion criteria (5 listed)
- history of psychotic disorder or current psychotic symptoms per the Structured Clinical Interview for DSM 4R - Patient version
- cognitive impair-ment sufficient to impair provision of informed consent or study participation
- current suicidality or homicidality
- use of NRT or other pharmacotherapy for smoking cessation
- use of other tobacco products
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 |
|---|---|---|
| Brief Computer Motivational Interviewing for Smoking CessationBrief computer motivational interviewing intervention to motivated tobacco quitline use | Behavioural | Brief Computer Motivational Interviewing for Smoking Cessation |
| Nutrition ControlComputer delivered nutrition education control condition | Behavioural | Nutrition Control |
Primary outcome
Engaged in tobacco cessation treatment since end of treatment intervention
Time frame: 3-months
1 secondary outcome
Number of quit smoking attempts since last assessment
Time frame: 3-months
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 20 Jul 2016.
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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.
Richard A. Brown, Ph.D. principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Computer Motivational Interviewing for Smoking Cessation in people with Smoking Cessation, run by Butler Hospital 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 3 inclusion and 5 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 20 Jul 2016. 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?
Engaged in tobacco cessation treatment since end of treatment intervention (time frame: 3-months). 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 20 Jul 2016.