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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01882673
Other study ID # DA034312
Secondary ID
Status Completed
Phase N/A
First received June 10, 2013
Last updated July 19, 2016
Start date August 2012
Est. completion date July 2014

Study information

Verified date July 2016
Source Butler Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief Computer Motivational Interviewing for Smoking Cessation
Brief computer motivational interviewing intervention to motivated tobacco quitline use
Nutrition Control
Computer delivered nutrition education control condition

Locations

Country Name City State
United States Butler Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

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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