Trial Outcomes & Findings for Enhancing Smoking Cessation in the Homeless Population (NCT NCT01932996)
NCT ID: NCT01932996
Last Updated: 2020-11-19
Results Overview
Smoking status is verified by measuring the concentration of carbon monoxide (CO) in expired air. Participants with a breath CO content less than or equal to 8 parts per million are characterized as abstinent from smoking for at least 7 days.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
352 participants
Primary outcome timeframe
7-day smoking abstinence at week 26 follow-up
Results posted on
2020-11-19
Participant Flow
Participant milestones
| Measure |
Integrated Intensive Smoking + Alcohol
IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
|
Usual Care
UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
|
|---|---|---|
|
Overall Study
STARTED
|
172
|
180
|
|
Overall Study
COMPLETED
|
170
|
180
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Integrated Intensive Smoking + Alcohol
IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
|
Usual Care
UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Enhancing Smoking Cessation in the Homeless Population
Baseline characteristics by cohort
| Measure |
Integrated Intensive Smoking + Alcohol
n=172 Participants
IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
|
Usual Care
n=180 Participants
UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
|
Total
n=352 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
|
167 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
46 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
46 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 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
|
127 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-day smoking abstinence at week 26 follow-upSmoking status is verified by measuring the concentration of carbon monoxide (CO) in expired air. Participants with a breath CO content less than or equal to 8 parts per million are characterized as abstinent from smoking for at least 7 days.
Outcome measures
| Measure |
Integrated Intensive Smoking + Alcohol
n=172 Participants
IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
|
Usual Care
n=180 Participants
UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
|
|---|---|---|
|
CO-verified Smoking Status at 26 Weeks
|
16.3 percentage of participants
|
12.6 percentage of participants
|
SECONDARY outcome
Timeframe: at weeks 12Smoking status is verified by measuring the concentration of carbon monoxide (CO) in expired air. Participants with a breath CO content less than or equal to 8 parts per million are characterized as abstinent from smoking for at least 7 days.
Outcome measures
| Measure |
Integrated Intensive Smoking + Alcohol
n=172 Participants
IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
|
Usual Care
n=180 Participants
UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
|
|---|---|---|
|
CO-verified Smoking Status at 12 Weeks
|
21.6 percentage of participants
|
14 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at week 26Participants will use a self-administered timeline-followback instrument, which asks them to retrospectively estimate their alcohol use in the 30 days prior to the report date. Outcome is reported as the mean number of continuous alcohol-free days over the past 30 day period.
Outcome measures
| Measure |
Integrated Intensive Smoking + Alcohol
n=172 Participants
IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
|
Usual Care
n=180 Participants
UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
|
|---|---|---|
|
Self-Reported Continuous Alcohol Abstinence for 30 Days
|
3.4 days
Standard Deviation .71
|
3.9 days
Standard Deviation .71
|
Adverse Events
Integrated Intensive Smoking + Alcohol
Serious events: 0 serious events
Other events: 90 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 101 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Integrated Intensive Smoking + Alcohol
n=172 participants at risk
IS+A: 12-week treatment with nicotine patch plus nicotine gum/lozenge. An integrated intensive smoking along with an intensive alcohol intervention covering smoking cessation + alcohol abstinence using cognitive behavioral therapy, CBT, and will include weekly individual sessions for 3 months followed by study data collection visits for 3 months.
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
Intensive Alcohol Intervention: Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
|
Usual Care
n=180 participants at risk
UC: 12-week treatment with nicotine patch plus nicotine gum/lozenge along with a one time brief smoking cessation and brief alcohol counseling both based on the USPHS's Guidelines
nicotine patch plus nicotine gum/lozenge: 12-week treatment with nicotine patch plus nicotine gum/lozenge
|
|---|---|---|
|
Psychiatric disorders
Addiction Services
|
0.00%
0/172 • 26 weeks
|
1.1%
2/180 • Number of events 2 • 26 weeks
|
|
Immune system disorders
Allergy
|
0.00%
0/172 • 26 weeks
|
0.56%
1/180 • Number of events 1 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.5%
6/172 • Number of events 7 • 26 weeks
|
1.1%
2/180 • Number of events 2 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Difficulties
|
3.5%
6/172 • Number of events 10 • 26 weeks
|
5.0%
9/180 • Number of events 11 • 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
2/172 • Number of events 2 • 26 weeks
|
0.56%
1/180 • Number of events 1 • 26 weeks
|
|
General disorders
Dehydration
|
0.00%
0/172 • 26 weeks
|
0.56%
1/180 • Number of events 1 • 26 weeks
|
|
General disorders
Dental Pain
|
1.2%
2/172 • Number of events 2 • 26 weeks
|
2.2%
4/180 • Number of events 4 • 26 weeks
|
|
Psychiatric disorders
Depression
|
1.7%
3/172 • Number of events 4 • 26 weeks
|
0.56%
1/180 • Number of events 1 • 26 weeks
|
|
Endocrine disorders
Diabetes
|
2.3%
4/172 • Number of events 4 • 26 weeks
|
0.00%
0/180 • 26 weeks
|
|
Eye disorders
Eye Irritation
|
0.58%
1/172 • Number of events 1 • 26 weeks
|
0.00%
0/180 • 26 weeks
|
|
General disorders
Fainting
|
1.7%
3/172 • Number of events 3 • 26 weeks
|
0.56%
1/180 • Number of events 1 • 26 weeks
|
|
General disorders
Flu-Like Symptoms
|
1.7%
3/172 • Number of events 3 • 26 weeks
|
0.00%
0/180 • 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
2.3%
4/172 • Number of events 4 • 26 weeks
|
2.2%
4/180 • Number of events 4 • 26 weeks
|
|
Injury, poisoning and procedural complications
Frostbite
|
0.58%
1/172 • Number of events 1 • 26 weeks
|
1.1%
2/180 • Number of events 2 • 26 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Issues
|
3.5%
6/172 • Number of events 6 • 26 weeks
|
2.2%
4/180 • Number of events 4 • 26 weeks
|
|
Reproductive system and breast disorders
Gynecological Issues
|
1.2%
2/172 • Number of events 2 • 26 weeks
|
1.1%
2/180 • Number of events 3 • 26 weeks
|
|
General disorders
Headache
|
1.2%
2/172 • Number of events 2 • 26 weeks
|
1.1%
2/180 • Number of events 3 • 26 weeks
|
|
Cardiac disorders
Heart Problems
|
1.2%
2/172 • Number of events 2 • 26 weeks
|
0.56%
1/180 • Number of events 1 • 26 weeks
|
|
Cardiac disorders
High Blood Pressure
|
1.2%
2/172 • Number of events 2 • 26 weeks
|
2.2%
4/180 • Number of events 4 • 26 weeks
|
|
Infections and infestations
Infection
|
2.9%
5/172 • Number of events 5 • 26 weeks
|
5.0%
9/180 • Number of events 10 • 26 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
5.2%
9/172 • Number of events 10 • 26 weeks
|
8.3%
15/180 • Number of events 17 • 26 weeks
|
|
General disorders
Medication Review
|
2.3%
4/172 • Number of events 4 • 26 weeks
|
1.1%
2/180 • Number of events 2 • 26 weeks
|
|
Skin and subcutaneous tissue disorders
NRT Patch Irritation
|
4.1%
7/172 • Number of events 8 • 26 weeks
|
11.7%
21/180 • Number of events 22 • 26 weeks
|
|
General disorders
Pain
|
5.8%
10/172 • Number of events 11 • 26 weeks
|
5.6%
10/180 • Number of events 12 • 26 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/172 • 26 weeks
|
1.7%
3/180 • Number of events 5 • 26 weeks
|
|
Psychiatric disorders
Suicidality
|
1.2%
2/172 • Number of events 4 • 26 weeks
|
0.00%
0/180 • 26 weeks
|
|
Surgical and medical procedures
Surgery
|
2.3%
4/172 • Number of events 4 • 26 weeks
|
0.00%
0/180 • 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place