- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01882673
Motivating Quitline Use Among Smokers in Treatment for Substance Use Disorders (MI-SUD)
July 19, 2016 updated by: Butler Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Butler Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief Computer Motivational Interviewing for Smoking Cessation
Brief computer motivational interviewing intervention to motivate tobacco quitline use
|
Brief computer motivational interviewing intervention to motivated tobacco quitline use
|
Active Comparator: Nutrition Control
Computer delivered nutrition education
|
Computer delivered nutrition education control condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Engaged in tobacco cessation treatment since end of treatment intervention
Time Frame: 3-months
|
3-months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of quit smoking attempts since last assessment
Time Frame: 3-months
|
3-months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Point prevalence smoking abstinence - last 7 days from time of assessment
Time Frame: 3-months
|
3-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
June 10, 2013
First Submitted That Met QC Criteria
June 19, 2013
First Posted (Estimate)
June 20, 2013
Study Record Updates
Last Update Posted (Estimate)
July 20, 2016
Last Update Submitted That Met QC Criteria
July 19, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DA034312
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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