Clinical trial NCT01783912: Helping Those With Mental Illness Quit Smoking
Official title: Preparing Those With Significant and Persistent Mental Illness to Quit Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Nicotine Dependence
Mental Disorders
Keywords: Smoking
Nicotine Dependence
Mental Disorders
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Acceptance of Wisconsin Tobacco Quit Line Services
timeFrame: 4-6 weeks after study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention
name: Bruce Christiansen, PhD
role: PRINCIPAL_INVESTIGATOR
References: