Treating Smokers With Mental Illness

Study Overview
=================
Brief Summary
-----------------
This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.

Detailed Description
-----------------
At the baseline measurement visit, participants will be asked to complete a survey and an interview. They will be randomly assigned to either the intervention or control group. Both groups will receive a smoking cessation manual and list of resources. The intervention group will also receive smoking cessation counseling and nicotine replacement therapy. Both groups will be seen for in-person assessments again at 8 weeks and 6 months post baseline.

Official Title
-----------------
Treating Tobacco Dependence in Smokers With Severe Mental Illness

Conditions
-----------------
Smoking Cessation, Cigarette Smoking, Schizophrenia, Psychotic Disorders, Major Depressive Disorder, Bipolar Disorder I, Bipolar II Disorder, Mental Illness

Intervention / Treatment
-----------------
* Drug: Nicotine patch
* Drug: Nicotine lozenge
* Behavioral: Therapy
* Other: Information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have a severe mental illness diagnosis be a daily smoker be willing to reduce the number of cigarettes smoked per day leading to a quit attempt want to try to quit smoking be willing to use nicotine replacement therapy be able to communicate in English Exclusion Criteria: anyone who has had an active psychotic episode or been hospitalized due to suicidal ideation in the last six months pregnancy taking Chantix or Clozapine having a terminal illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges. | Drug: Nicotine patch<br>* Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use<br>Drug: Nicotine lozenge<br>* Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use<br>Behavioral: Therapy<br>* In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase<br>Other: Information<br>* Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community<br>|
| Other: Control<br>Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation. | Other: Information<br>* Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-Day Point Prevalence Abstinence | To determine the number of patients in the intervention and control conditions who achieve 7-day point prevalence abstinence at 8 weeks and 6 months after enrollment. | 8 weeks and 6 months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quit Attempts | To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts. | 8 weeks and 6 months post baseline | 
| Smoking Reduction | To determine the mean reduction in cigarettes per day in the intervention and control conditions. | 8 weeks and 6 months post baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mental illness, tobacco treatment