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Helping Those With Mental Illness Quit Smoking

Primary Purpose

Smoking, Nicotine Dependence, Mental Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cognitive / Motivational Individual Sessions
Attention Control Individual Sessions
Nicotine Patch
Group Curriculum
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring Smoking, Nicotine Dependence, Mental Disorders

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • current smoker (smoking daily or smoking at least 10 cigarettes per week) (use of other tobacco products permitted such as chew and snuz in addition to smoking)
  • not willing to make a quit attempt
  • willingness to use the nicotine patch
  • plans to remain in the area for the next five four months.

Exclusion Criteria:

  • current use of any cessation medicine (nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler, nicotine nasal spray, bupropion, Wellbutrin, Zyban,Chantix or varenicline)
  • previous serious skin reaction or other allergic reaction to using the nicotine patch
  • stroke, heart attack or abnormal electrocardiogram in past four weeks
  • pregnancy, plans to get pregnant or nursing
  • exclusive use of other tobacco products (non-smoker tobacco user)
  • having a court-ordered guardian, or an activated power of attorney for health or observation by researchers during the consent procedure that suggests diminished decision making capacity

Sites / Locations

  • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Cognitive/Motivational Intervention Group

Attention Control Group

Motivated Smokers Comparison Group

Arm Description

This arm of the project will address the following questions: After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group? After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?

This arm of the project will address the following question: After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group? After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?

This arm of the project will address the following question: Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group? Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group? Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services.

Outcomes

Primary Outcome Measures

Acceptance of Wisconsin Tobacco Quit Line Services
The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2013
Last Updated
January 29, 2016
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01783912
Brief Title
Helping Those With Mental Illness Quit Smoking
Official Title
Preparing Those With Significant and Persistent Mental Illness to Quit Smoking
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study tests whether pre-cessation interventions known to be effective in the general population will increase acceptance of evidence-based treatment, engagement and compliance with that treatment and initial quitting success. One hundred and seventy two patients will be recruited from 13 Community Support Programs (CSPs). CSPs provide community based care to those diagnosed with persistent and serious mental illness. All participants will receive two group sessions (40 minutes each) modeled after "Kicking Butts", a group-based quitting preparation program used for the past four years in two Milwaukee CSP programs run by Wisconsin Community Services. Individuals will then be randomly assigned to the experimental and control conditions (n=86 each). Experimental subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each). Attention control subjects will also receive four individual sessions of the same duration. However their individual sessions' content will be a discussion of the personal relevance of the group material and will not include any of the preparatory interventions. Data will be collected via brief surveys taken pre-intervention, at the end of the last individual session, and three months later and from a database provided by the Wisconsin Tobacco Quit Line (WTQL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Nicotine Dependence, Mental Disorders
Keywords
Smoking, Nicotine Dependence, Mental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive/Motivational Intervention Group
Arm Type
Experimental
Arm Description
This arm of the project will address the following questions: After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group? After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?
Arm Title
Attention Control Group
Arm Type
Active Comparator
Arm Description
This arm of the project will address the following question: After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group? After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?
Arm Title
Motivated Smokers Comparison Group
Arm Type
No Intervention
Arm Description
This arm of the project will address the following question: Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group? Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group? Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive / Motivational Individual Sessions
Intervention Description
Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).
Intervention Type
Behavioral
Intervention Name(s)
Attention Control Individual Sessions
Intervention Description
Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking.
Intervention Type
Drug
Intervention Name(s)
Nicotine Patch
Intervention Description
Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Group Curriculum
Intervention Description
Everyone to be put into the experimental or active comparator group will attend 2 group meetings over two weeks each of which lasts 40 minutes. Experience with the Kicking Butts program indicates that this duration is well tolerated by this population. The content of these two group meetings is based on the Kicking Butts program. The Kicking Butts program was initially developed as a cessation intervention, but consistent with the literature about the need to prepare this population to make a quit attempt, has evolved to emphasize preparation for quitting. Topics addressed include the health consequences of smoking, reasons to quit and methods of quitting.
Primary Outcome Measure Information:
Title
Acceptance of Wisconsin Tobacco Quit Line Services
Description
The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.
Time Frame
4-6 weeks after study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: current smoker (smoking daily or smoking at least 10 cigarettes per week) (use of other tobacco products permitted such as chew and snuz in addition to smoking) not willing to make a quit attempt willingness to use the nicotine patch plans to remain in the area for the next five four months. Exclusion Criteria: current use of any cessation medicine (nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler, nicotine nasal spray, bupropion, Wellbutrin, Zyban,Chantix or varenicline) previous serious skin reaction or other allergic reaction to using the nicotine patch stroke, heart attack or abnormal electrocardiogram in past four weeks pregnancy, plans to get pregnant or nursing exclusive use of other tobacco products (non-smoker tobacco user) having a court-ordered guardian, or an activated power of attorney for health or observation by researchers during the consent procedure that suggests diminished decision making capacity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Christiansen, PhD
Organizational Affiliation
University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ctri.wisc.edu/
Description
University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention Website

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Helping Those With Mental Illness Quit Smoking

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