Helping Those With Mental Illness Quit Smoking
Condition: Smoking; Nicotine Dependence; Mental Disorders
MeSH terms: Tobacco Use Disorder; Mental Disorders; Psychotic Disorders
Intervention: Cognitive / Motivational Individual Sessions; Attention Control Individual Sessions; Nicotine Patch; Group Curriculum
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).; 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.; Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks.; 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.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Smoking; Nicotine Dependence; Mental Disorders

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).
    

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