Trial Outcomes & Findings for Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers (NCT NCT01723163)
NCT ID: NCT01723163
Last Updated: 2019-03-01
Results Overview
Non-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
310 participants
Primary outcome timeframe
6-month post-treatment
Results posted on
2019-03-01
Participant Flow
Participants who did not complete a follow-up were not prohibited from participating in the remaining study follow-up periods.
Participant milestones
| Measure |
Intervention
Abstinence Reinforcement Therapy (ART)
Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)
|
Control
Telephone Counseling
Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)
|
|---|---|---|
|
Baseline
STARTED
|
156
|
154
|
|
Baseline
COMPLETED
|
156
|
154
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Treatment Phase
STARTED
|
156
|
154
|
|
Treatment Phase
COMPLETED
|
137
|
147
|
|
Treatment Phase
NOT COMPLETED
|
19
|
7
|
|
3-Month Follow-up
STARTED
|
137
|
147
|
|
3-Month Follow-up
COMPLETED
|
124
|
128
|
|
3-Month Follow-up
NOT COMPLETED
|
13
|
19
|
|
6-Month Follow-up
STARTED
|
136
|
147
|
|
6-Month Follow-up
COMPLETED
|
118
|
132
|
|
6-Month Follow-up
NOT COMPLETED
|
18
|
15
|
|
12-Month Follow-up
STARTED
|
135
|
147
|
|
12-Month Follow-up
COMPLETED
|
111
|
119
|
|
12-Month Follow-up
NOT COMPLETED
|
24
|
28
|
Reasons for withdrawal
| Measure |
Intervention
Abstinence Reinforcement Therapy (ART)
Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)
|
Control
Telephone Counseling
Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)
|
|---|---|---|
|
Treatment Phase
Withdrawal by Subject
|
14
|
6
|
|
Treatment Phase
Withdrawal by PI
|
5
|
1
|
|
3-Month Follow-up
Withdrawal by Subject
|
1
|
0
|
|
3-Month Follow-up
Unable to Contact
|
12
|
19
|
|
6-Month Follow-up
Death
|
1
|
0
|
|
6-Month Follow-up
Unable to Contact
|
17
|
15
|
|
12-Month Follow-up
Death
|
1
|
0
|
|
12-Month Follow-up
Unable to Contact
|
23
|
28
|
Baseline Characteristics
Abstinence Reinforcement Therapy (ART) for Rural Veteran Smokers
Baseline characteristics by cohort
| Measure |
Intervention
n=156 Participants
Abstinence Reinforcement Therapy (ART)
Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)
|
Control
n=154 Participants
Telephone Counseling
Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 11 • n=5 Participants
|
56 years
STANDARD_DEVIATION 11 • n=7 Participants
|
57 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
85 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
More than High School
|
101 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Education
High School or less
|
55 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Distance to nearest VA hospital or clinic (miles)
0-20 Miles
|
56 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Distance to nearest VA hospital or clinic (miles)
21-40 Miles
|
49 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Distance to nearest VA hospital or clinic (miles)
41-60 Miles
|
35 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Distance to nearest VA hospital or clinic (miles)
61-80 Miles
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Distance to nearest VA hospital or clinic (miles)
81-100 Miles
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Distance to nearest VA hospital or clinic (miles)
101 Miles or more
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence
|
4 units on a scale
STANDARD_DEVIATION 2 • n=5 Participants
|
4 units on a scale
STANDARD_DEVIATION 2 • n=7 Participants
|
4 units on a scale
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Self efficacy scale for quitting smoking in next 6 months
|
6 units on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
6 units on a scale
STANDARD_DEVIATION 1 • n=7 Participants
|
6 units on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6-month post-treatmentNon-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.
Outcome measures
| Measure |
Intervention
n=156 Participants
Abstinence Reinforcement Therapy (ART)
Abstinence Reinforcement Therapy (ART): Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)
|
Control
n=154 Participants
Telephone Counseling
Telephone Counseling and NRT: Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)
|
|---|---|---|
|
Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up
Abstinent
|
38 Participants
|
40 Participants
|
|
Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up
Non-Abstinent
|
77 Participants
|
83 Participants
|
|
Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up
Missing
|
41 Participants
|
31 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 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
Adverse event data not reported
Additional Information
Dr. Patrick Calhoun
Durham Veterans Affairs Medical Center
Phone: 919-286-0411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place