NCT01882673

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

1.7 years

First QC Date

June 10, 2013

Last Update Submit

July 19, 2016

Conditions

Keywords

Tobacconicotinedependencequitline

Outcome Measures

Primary Outcomes (1)

  • Engaged in tobacco cessation treatment since end of treatment intervention

    3-months

Secondary Outcomes (1)

  • Number of quit smoking attempts since last assessment

    3-months

Other Outcomes (1)

  • Point prevalence smoking abstinence - last 7 days from time of assessment

    3-months

Study Arms (2)

Brief Computer Motivational Interviewing for Smoking Cessation

EXPERIMENTAL

Brief computer motivational interviewing intervention to motivate tobacco quitline use

Behavioral: Brief Computer Motivational Interviewing for Smoking Cessation

Nutrition Control

ACTIVE COMPARATOR

Computer delivered nutrition education

Behavioral: Nutrition Control

Interventions

Brief computer motivational interviewing intervention to motivated tobacco quitline use

Brief Computer Motivational Interviewing for Smoking Cessation

Computer delivered nutrition education control condition

Nutrition Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Richard A. Brown, Ph.D.

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 20, 2013

Study Start

August 1, 2012

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations