Treating Smokers With Mental Illness

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT03822416
• Collaborator: Hennepin County Medical Center, Minneapolis (Other), Brown University (Other)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.1
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation; Cigarette Smoking; Schizophrenia; Psychotic Disorders; Major Depressive Disorder; Bipolar Disorder I; Bipolar II Disorder; Mental Illness	Drug: Nicotine patch; Drug: Nicotine lozenge; Behavioral: Therapy; Other: Information	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Primary Purpose: Treatment
• Official Title: Treating Tobacco Dependence in Smokers With Severe Mental Illness
• Actual Study Start Date: Mar 1, 2019
• Actual Primary Completion Date: May 4, 2020
• Actual Study Completion Date: May 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.	Drug: 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; Drug: 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; Behavioral: 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; Other: Information; Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community
Other: Control 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; Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Smoking Reduction [8 weeks and 6 months post baseline]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota
• Hennepin County Medical Center, Minneapolis
• Brown University

Investigators

• Principal Investigator: Harry Lando, PhD, University of Minnesota

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 16, 2019
• Informed Consent Form - Jul 15, 2019

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03822416
• Other Study ID Numbers: SPH-2018-26854
• First Posted: Jan 30, 2019
• Last Update Posted: May 25, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Minnesota: mental illness; tobacco treatment
• Additional relevant MeSH terms: Disease; Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Mental Disorders; Psychotic Disorders; Nicotine

Study Results

Participant Flow

Arm/Group Title	Intervention	Control
Arm/Group Description	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 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
Period Title: Overall Study
STARTED	19	19
COMPLETED	18	18
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	19	19	38
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 94.7%	19 100%	37 97.4%
>=65 years	1 5.3%	0 0%	1 2.6%
Sex/Gender, Customized (Count of Participants)
Female	6 31.6%	12 63.2%	18 47.4%
Male	11 57.9%	7 36.8%	18 47.4%
Other	2 10.5%	0 0%	2 5.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 5.3%	0 0%	1 2.6%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 42.1%	3 15.8%	11 28.9%
White	8 42.1%	10 52.6%	18 47.4%
More than one race	1 5.3%	6 31.6%	7 18.4%
Unknown or Not Reported	1 5.3%	0 0%	1 2.6%
Region of Enrollment (participants) [Number]
United States	19 100%	19 100%	38 100%

Outcome Measures

1. Primary Outcome

Title	7-Day Point Prevalence Abstinence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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 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
Measure Participants	19	19
8 Weeks	5 26.3%	3 15.8%
6 Months	4 21.1%	5 26.3%

2. Secondary Outcome

Title	Quit Attempts
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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 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
Measure Participants	19	19
8 Weeks	13 68.4%	7 36.8%
6 Months	18 94.7%	10 52.6%

3. Secondary Outcome

Title	Smoking Reduction
Description	To determine the mean reduction in cigarettes per day in the intervention and control conditions.
Time Frame	8 weeks and 6 months post baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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 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
Measure Participants	19	19
8 Weeks	5.6 (7.04)	11.59 (4.15)
6 Months	4.84 (4.56)	8.03 (3.23)

Adverse Events

Time Frame	6 months
Arm/Group Title	Intervention		Control
Arm/Group Description	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 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
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/19 (5.3%)		0/19 (0%)
Respiratory, thoracic and mediastinal disorders
increased coughing following smoking cessation	1/19 (5.3%)	1	0/19 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.