Trial Outcomes & Findings for Treating Smokers With Mental Illness (NCT NCT03822416)

NCT ID: NCT03822416

Last Updated: 2021-05-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: 8 weeks and 6 months post baseline
• Results posted on: 2021-05-25

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	19	19
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Treating Smokers With Mental Illness

Baseline characteristics by cohort

Measure	Intervention n=19 Participants 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	Control n=19 Participants 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	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex/Gender, Customized Female	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Sex/Gender, Customized Male	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Sex/Gender, Customized Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=19 Participants 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	Control n=19 Participants 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
7-Day Point Prevalence Abstinence 8 Weeks	5 Participants	3 Participants
7-Day Point Prevalence Abstinence 6 Months	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=19 Participants 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	Control n=19 Participants 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
Quit Attempts 8 Weeks	13 Participants	7 Participants
Quit Attempts 6 Months	18 Participants	10 Participants

SECONDARY outcome

Timeframe: 8 weeks and 6 months post baseline

To determine the mean reduction in cigarettes per day in the intervention and control conditions.

Outcome measures

Measure	Intervention n=19 Participants 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	Control n=19 Participants 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
Smoking Reduction 8 Weeks	5.6 cigarettes per day Standard Deviation 7.04	11.59 cigarettes per day Standard Deviation 4.15
Smoking Reduction 6 Months	4.84 cigarettes per day Standard Deviation 4.56	8.03 cigarettes per day Standard Deviation 3.23

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=19 participants at risk 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	Control n=19 participants at risk 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
Respiratory, thoracic and mediastinal disorders increased coughing following smoking cessation	5.3% 1/19 • Number of events 1 • 6 months	0.00% 0/19 • 6 months

Additional Information

Harry Lando, PhD

University of Minnesota

Phone: 612-624-1877

Email: lando001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place