Trial Outcomes & Findings for Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk (NCT NCT00861146)
NCT ID: NCT00861146
Last Updated: 2020-04-03
Results Overview
7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
151 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-04-03
Participant Flow
Enrollment May 2009 to October 2012. Excluded (n=1448): Does not smoke, does not drink (n=678) Declined to participate (n=320) Medical problems (n=297) Otherwise ineligible (n=112) Male non-vet (n=41)
Participant milestones
| Measure |
1 Concurrent Smoking Cessation
smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
2 Deferred Smoking Cessation
smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
46
|
|
Overall Study
Week 2 Assessment
|
97
|
45
|
|
Overall Study
Week 13 Assessment
|
85
|
38
|
|
Overall Study
COMPLETED
|
85
|
38
|
|
Overall Study
NOT COMPLETED
|
20
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Concurrent Alcohol and Smoking Treatment: Effects on Alcohol Relapse Risk
Baseline characteristics by cohort
| Measure |
1 Concurrent Smoking Cessation
n=105 Participants
smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
2 Deferred Smoking Cessation
n=46 Participants
smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 8.68 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
43 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=5 Participants
|
46 participants
n=7 Participants
|
151 participants
n=5 Participants
|
|
Cigarettes smoked/day
|
16.0 cigarettes
STANDARD_DEVIATION 8.0 • n=5 Participants
|
16.8 cigarettes
STANDARD_DEVIATION 10.0 • n=7 Participants
|
16.2 cigarettes
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Proportion days heavy drinking
|
.58 proportion
STANDARD_DEVIATION .33 • n=5 Participants
|
.52 proportion
STANDARD_DEVIATION .38 • n=7 Participants
|
.56 proportion
STANDARD_DEVIATION .35 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Outcome measures
| Measure |
1 Concurrent Smoking Cessation
n=105 Participants
smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
2 Deferred Smoking Cessation
n=46 Participants
smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
|---|---|---|
|
Smoking Abstinence
|
20 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 2 weeks7-day point prevalence smoking abstinence verified by breath carbon monoxide missing coded as smoking
Outcome measures
| Measure |
1 Concurrent Smoking Cessation
n=105 Participants
smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
2 Deferred Smoking Cessation
n=46 Participants
smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
|---|---|---|
|
Smoking Abstinence
|
53 participants
|
1 participants
|
SECONDARY outcome
Timeframe: follow-up weeks 9-12Heavy drinking days were defined as days with \> 6 standard drinks per day for men and \> 4 standard drinks per day for women. This measure examined the proportion of days heavy drinking across 28 days in follow-up weeks 9-12.
Outcome measures
| Measure |
1 Concurrent Smoking Cessation
n=85 Participants
smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
2 Deferred Smoking Cessation
n=38 Participants
smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
|---|---|---|
|
Proportion of Days Heavy Drinking
|
.0332 proportion of days
Standard Deviation .1130
|
.0132 proportion of days
Standard Deviation .0375
|
Adverse Events
1 Concurrent Smoking Cessation
Serious events: 4 serious events
Other events: 60 other events
Deaths: 0 deaths
2 Deferred Smoking Cessation
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Concurrent Smoking Cessation
n=105 participants at risk
smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
2 Deferred Smoking Cessation
n=46 participants at risk
smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
|---|---|---|
|
Psychiatric disorders
Hospitalization psychiatric
|
1.9%
2/105 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
|
Psychiatric disorders
Hospitalization alcohol
|
0.95%
1/105 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Hospitalization stroke
|
0.95%
1/105 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Hospitalization gastrointestinal
|
0.00%
0/105
|
2.2%
1/46 • Number of events 1
|
Other adverse events
| Measure |
1 Concurrent Smoking Cessation
n=105 participants at risk
smoking cessation delivered concurrent with intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
2 Deferred Smoking Cessation
n=46 participants at risk
smoking cessation delivered 12 weeks after intensive alcohol treatment
behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum
|
|---|---|---|
|
Psychiatric disorders
vivid dreams
|
30.5%
32/105 • Number of events 32
|
15.2%
7/46 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
itching or irritation
|
28.6%
30/105 • Number of events 30
|
10.9%
5/46 • Number of events 5
|
|
Gastrointestinal disorders
dry mouth
|
18.1%
19/105 • Number of events 19
|
6.5%
3/46 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
coughing
|
13.3%
14/105 • Number of events 14
|
6.5%
3/46 • Number of events 3
|
|
Psychiatric disorders
insomnia
|
7.6%
8/105 • Number of events 8
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
heartburn or indigestion
|
7.6%
8/105 • Number of events 8
|
2.2%
1/46 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
6.7%
7/105 • Number of events 7
|
4.3%
2/46 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
5.7%
6/105 • Number of events 6
|
4.3%
2/46 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place