Helping Those With Mental Illness Quit Smoking

Smoking Clinical Trial

Official title:

Preparing Those With Significant and Persistent Mental Illness to Quit Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783912
• Other study ID #: 2011-0604
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2013
• Last updated: January 29, 2016
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Mental Disorders
• Nicotine Dependence
• Psychotic Disorders
• Smoking
• Tobacco Use Disorder

Intervention

Behavioral:
• Cognitive / Motivational Individual Sessions
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).
• Attention Control Individual Sessions
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.

Drug:
• Nicotine Patch
Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks.

Behavioral:
• Group Curriculum
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.

Locations

Country	Name	City	State
United States	University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4-6 weeks after study enrollment	No

External Links

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