Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness

July 13, 2017 updated by: Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
This project will assess the utility of a brief motivational intervention to engage smokers with schizophrenia in treatment for tobacco dependence treatment. It is hypothesized that a brief motivational intervention will be more effective in engaging smokers with schizophrenia to tobacco dependence treatment than an educational intervention. The educational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by teaching subjects about the negative effects of smoking and the success of tobacco dependence treatment. The motivational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by increasing subjects' motivation to change by presenting objective and personalized information regarding their smoking behaviors in a non-judgmental and supportive manner.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See Brief Summary above.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 1

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

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • UMDNJ- Robert Wood Johnson Medical School

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current smokers must be over the age of 18,
  • Must have a diagnosis of schizophrenia or schizoaffective disorder
  • Must smoke at least 10 cigarettes per day
  • Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22

Exclusion Criteria:

•Those unable to give informed consent.

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: Motivational Interviewing
Behavioral: Motivational Interviewing
Motivational Interviewing
Active Comparator: Psychoeducation
Behavioral: Psychoeducation
Psychoeducation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Attendance at first smoking cessation session
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
Cigarettes per day
Time Frame: 1-Month Follow Up
1-Month Follow Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Marc L. Steinberg, PH.D., Rutgers, the State University of New Jersey

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

May 1, 2006

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria

July 12, 2007

First Posted (Estimate)

July 13, 2007

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220045018
  • K23DA018203 (U.S. NIH Grant/Contract)

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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