Enhancing Smoking Cessation in the Homeless Population
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/14/2018 |
| Start Date: | January 2015 |
| End Date: | March 31, 2019 |
The goal of this research study is to enhance smoking cessation rates for homeless smokers.
The original study design proposed to test the effects of 1) an Intensive Smoking
Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will
utilize a 3-group randomized design to test study hypotheses. The three study conditions are
1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy
(CBT), CBT—(IS+A); 2) Intensive Smoking Intervention using CBT—(IS); or 3) Usual Care (brief
smoking cessation and brief alcohol counseling both based on the United States Public Health
Service's Guidelines)—(UC). Due to low enrollment because of the addition of an alcohol use
screening criteria, the study was changed to a two arm study and the study time frame
changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol
intervention using cognitive behavioral therapy (CBT), CBT—(IS+A) and 2) Usual Care (brief
smoking cessation and brief alcohol counseling both based on the United States Public Health
Service's Guidelines)—(UC). The study length is reduced to 26 weeks from 52 weeks. All
participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge.
Counseling will follows the protocol used in a recent study of alcohol dependent smokers and
will include weekly individual sessions for 3 months followed by study data collection visits
3 months. Both study conditions will have equal number of study contacts. Study staff will
make retention contacts with participants in the community during weeks that do not have
study visits scheduled. Primary smoking outcome is cotinine-verified 7-day smoking abstinence
at week 26 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 16,
and 26. Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90
days at week 26. Recruitment and retention will be enhanced by use of gift cards, bus passes,
other non-monetary incentives, attractive intervention materials, collaboration with homeless
shelters, and advice from a Community Advisory Board. Participants will be enrolled from
homeless shelters and facilities in the 7-county greater Minneapolis/St. Paul metro area. Our
power calculation indicates that a sample size of 215 per study condition is needed to detect
proposed treatment effects.
The original study design proposed to test the effects of 1) an Intensive Smoking
Intervention, and 2) integrating alcohol abuse treatment with smoking cessation We will
utilize a 3-group randomized design to test study hypotheses. The three study conditions are
1) Integrated Intensive Smoking plus Alcohol intervention using cognitive behavioral therapy
(CBT), CBT—(IS+A); 2) Intensive Smoking Intervention using CBT—(IS); or 3) Usual Care (brief
smoking cessation and brief alcohol counseling both based on the United States Public Health
Service's Guidelines)—(UC). Due to low enrollment because of the addition of an alcohol use
screening criteria, the study was changed to a two arm study and the study time frame
changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol
intervention using cognitive behavioral therapy (CBT), CBT—(IS+A) and 2) Usual Care (brief
smoking cessation and brief alcohol counseling both based on the United States Public Health
Service's Guidelines)—(UC). The study length is reduced to 26 weeks from 52 weeks. All
participants will receive 12-week treatment with nicotine patch plus nicotine gum/lozenge.
Counseling will follows the protocol used in a recent study of alcohol dependent smokers and
will include weekly individual sessions for 3 months followed by study data collection visits
3 months. Both study conditions will have equal number of study contacts. Study staff will
make retention contacts with participants in the community during weeks that do not have
study visits scheduled. Primary smoking outcome is cotinine-verified 7-day smoking abstinence
at week 26 follow-up while secondary outcome is prolonged smoking abstinence at weeks 12, 16,
and 26. Secondary alcohol outcome will be self-reported continuous alcohol abstinence for 90
days at week 26. Recruitment and retention will be enhanced by use of gift cards, bus passes,
other non-monetary incentives, attractive intervention materials, collaboration with homeless
shelters, and advice from a Community Advisory Board. Participants will be enrolled from
homeless shelters and facilities in the 7-county greater Minneapolis/St. Paul metro area. Our
power calculation indicates that a sample size of 215 per study condition is needed to detect
proposed treatment effects.
To achieve the study goal, we have selected a 3-group randomized clinical trial (RCT) design
that includes 1) Usual Care, 2) Intensive smoking cessation, and 3) Integrated Intensive
Smoking and Alcohol Intervention. Due to low enrollment because of the addition of an alcohol
use screening criteria, the study was changed to a two arm study and the study time frame
changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol
intervention using cognitive behavioral therapy (CBT), CBT—(IS+A) and 2) Usual Care (brief
smoking cessation and brief alcohol counseling both based on the United States Public Health
Service's Guidelines)—(UC). The study length is reduced to 26 weeks from 52 weeks. Having
alcohol treatment added to the smoking intervention will enable us assess whether addressing
alcohol abuse will result in improved smoking abstinence, an important scientific question
that has never been studied in homeless populations.
Study conditions: Both study conditions have identical number of contacts; we considered a
design in which the duration of counseling in the UC will be identical to those in the IS+A
condition but decided against this because it will create a usual care condition that exceeds
standard practice for brief interventions. We understand that testing hypothesis 3 confounds
contact time with treatment content, and hence we will not be able to determine that observed
differences in outcome are due to specific treatment components. However, given the current
state of knowledge about treating homeless alcohol abusing smokers, we believe it is
sufficient to show that our intervention led to improved outcome in this group without
knowing if the finding is due to specific intervention content. Subsequent research will be
needed to disentangle various intervention components.
All participants will receive 12-week treatment with nicotine patch plus nicotine
gum/lozenge. Counseling will include weekly individual sessions for 3 months followed by
study data collection visits for 3 months. Each participant will be randomly assigned to a
condition, which will dictate their treatment. Each participant will be asked to engage in
the therapy assigned to their condition, and work to quit smoking and consuming alcohol over
a period of one year.
that includes 1) Usual Care, 2) Intensive smoking cessation, and 3) Integrated Intensive
Smoking and Alcohol Intervention. Due to low enrollment because of the addition of an alcohol
use screening criteria, the study was changed to a two arm study and the study time frame
changed. The two study conditions are 1) Integrated Intensive Smoking plus Alcohol
intervention using cognitive behavioral therapy (CBT), CBT—(IS+A) and 2) Usual Care (brief
smoking cessation and brief alcohol counseling both based on the United States Public Health
Service's Guidelines)—(UC). The study length is reduced to 26 weeks from 52 weeks. Having
alcohol treatment added to the smoking intervention will enable us assess whether addressing
alcohol abuse will result in improved smoking abstinence, an important scientific question
that has never been studied in homeless populations.
Study conditions: Both study conditions have identical number of contacts; we considered a
design in which the duration of counseling in the UC will be identical to those in the IS+A
condition but decided against this because it will create a usual care condition that exceeds
standard practice for brief interventions. We understand that testing hypothesis 3 confounds
contact time with treatment content, and hence we will not be able to determine that observed
differences in outcome are due to specific treatment components. However, given the current
state of knowledge about treating homeless alcohol abusing smokers, we believe it is
sufficient to show that our intervention led to improved outcome in this group without
knowing if the finding is due to specific intervention content. Subsequent research will be
needed to disentangle various intervention components.
All participants will receive 12-week treatment with nicotine patch plus nicotine
gum/lozenge. Counseling will include weekly individual sessions for 3 months followed by
study data collection visits for 3 months. Each participant will be randomly assigned to a
condition, which will dictate their treatment. Each participant will be asked to engage in
the therapy assigned to their condition, and work to quit smoking and consuming alcohol over
a period of one year.
Inclusion Criteria:
- Currently Homeless
- Smoked at least 100 cigarettes in lifetime
- AUDIT score of > or equal to 5, < or equal to 26
- Aged 18 years or older
- Willing to attend study sessions and follow other study protocol
Exclusion Criteria:
- Use of smoking cessation medications or interventions in last 30 days
- Unstable medical illness that requires immediate medical care
- AUDIT score of < 5 or > 26
- Pregnancy or other Nicotine Replacement Therapy (NRT) contraindications
- Current history or in past 6 months of psychotic disorder or major depressive
disorders that is not stable on treatment for past 3 months
- Cognitive impairment
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