Smoking Cessation Clinical Trial
— MI-SUDOfficial title:
Brief Computer Intervention to Motivate Quitline Use for Smokers in SUD Treatment
Verified date | July 2016 |
Source | Butler Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | July 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Butler Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Butler Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Point prevalence smoking abstinence - last 7 days from time of assessment | 3-months | No | |
Primary | Engaged in tobacco cessation treatment since end of treatment intervention | 3-months | No | |
Secondary | Number of quit smoking attempts since last assessment | 3-months | No |
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