Bipolar Disorder I, Bipolar II Disorder, Cigarette Smoking, Major Depressive Disorder, Mental Illness, Psychotic Disorders, Schizophrenia, Smoking Cessation
Conditions
Keywords
mental illness, tobacco treatment
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.
Interventions
DRUGNicotine patch
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
DRUGNicotine lozenge
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
BEHAVIORALTherapy
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
OTHERInformation
Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community
Sponsors
Hennepin County Medical Center, Minneapolis
Brown University
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will not be made aware of the participant's study status, although it may become obvious during the assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Point Prevalence Abstinence | 8 weeks and 6 months post baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quit Attempts | 8 weeks and 6 months post baseline | To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts. |
| Smoking Reduction | 8 weeks and 6 months post baseline | To determine the mean reduction in cigarettes per day in the intervention and control conditions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.
Nicotine patch: 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
Nicotine lozenge: 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
Therapy: 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
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community | 19 |
| Control Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.
Information: Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community | 19 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 19 Participants | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 18 Participants |
| Region of Enrollment United States | 19 participants | 19 participants | 38 participants |
| Sex/Gender, Customized Female | 6 Participants | 12 Participants | 18 Participants |
| Sex/Gender, Customized Male | 11 Participants | 7 Participants | 18 Participants |
| Sex/Gender, Customized Other | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 1 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
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.
Time frame: 8 weeks and 6 months post baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | 7-Day Point Prevalence Abstinence | 8 Weeks | 5 Participants |
| Intervention | 7-Day Point Prevalence Abstinence | 6 Months | 4 Participants |
| Control | 7-Day Point Prevalence Abstinence | 8 Weeks | 3 Participants |
| Control | 7-Day Point Prevalence Abstinence | 6 Months | 5 Participants |
Secondary
Quit Attempts
To determine the number of patients in the intervention and control condition who achieve self-reported minimum 24 hour quit attempts.
Time frame: 8 weeks and 6 months post baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Quit Attempts | 8 Weeks | 13 Participants |
| Intervention | Quit Attempts | 6 Months | 18 Participants |
| Control | Quit Attempts | 8 Weeks | 7 Participants |
| Control | Quit Attempts | 6 Months | 10 Participants |
Secondary
Smoking Reduction
To determine the mean reduction in cigarettes per day in the intervention and control conditions.
Time frame: 8 weeks and 6 months post baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Smoking Reduction | 6 Months | 4.84 cigarettes per day | Standard Deviation 4.56 |
| Intervention | Smoking Reduction | 8 Weeks | 5.6 cigarettes per day | Standard Deviation 7.04 |
| Control | Smoking Reduction | 6 Months | 8.03 cigarettes per day | Standard Deviation 3.23 |
| Control | Smoking Reduction | 8 Weeks | 11.59 cigarettes per day | Standard Deviation 4.15 |