Trial Outcomes & Findings for Automated Reinforcement Management System (ARMS) (NCT NCT04656925)
NCT ID: NCT04656925
Last Updated: 2025-02-05
Results Overview
Change in biochemically measured alcohol abstinence assessed through breath samples submitted three times daily.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Daily during 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)
Results posted on
2025-02-05
Participant Flow
Participant milestones
| Measure |
Contingency Management A-B-A
All participants will be assigned a single arm where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods.
Contingency management: Reinforcement, or incentives, in exchange for evidence of not drinking alcohol.
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|---|---|
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Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Automated Reinforcement Management System (ARMS)
Baseline characteristics by cohort
| Measure |
Contingency Management A-B-A
n=12 Participants
All participants will be assigned a single arm where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods.
Contingency management: Reinforcement, or incentives, in exchange for evidence of not drinking alcohol.
|
|---|---|
|
Age, Continuous
|
39.5 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
Employment
Employed
|
9 Participants
n=5 Participants
|
|
Employment
Unemployed
|
3 Participants
n=5 Participants
|
|
Baseline EtG Result
Positive
|
11 Participants
n=5 Participants
|
|
Baseline EtG Result
Negative
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Daily during 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)Population: This is a within subject design (each participant goes through all three phases, the two A phases are control phases and B is the experimental phase). The overall number of units is total BAC submission for all phases. The numbers analyzed below differ based on total number of samples submitted by phase.
Change in biochemically measured alcohol abstinence assessed through breath samples submitted three times daily.
Outcome measures
| Measure |
Contingency Management A-B-A
n=2016 Total BAC samples submitted
All participants will be assigned a single arm where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods.
Contingency management: Reinforcement, or incentives, in exchange for evidence of not drinking alcohol.
|
|---|---|
|
Biochemically Measured Change in Alcohol Abstinence.
First A Phase
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347 Number of negative BAC samples by phase.
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|
Biochemically Measured Change in Alcohol Abstinence.
B Phase
|
615 Number of negative BAC samples by phase.
|
|
Biochemically Measured Change in Alcohol Abstinence.
Second A Phase
|
209 Number of negative BAC samples by phase.
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SECONDARY outcome
Timeframe: 8 weeks (2 weeks of first A phase, 4 weeks of B phase, and 2 second A phase)Population: This is a within subject design (each participant goes through all three phases, the two A phases are control phases and B is the experimental phase). The overall number of units is total BAC submission for all phases. The numbers analyzed below differ based on total number of samples submitted by phase.
Percentage of actual BAC samples submitted by the total number of possible submissions.
Outcome measures
| Measure |
Contingency Management A-B-A
n=2016 Total possible submissions of BAC sample
All participants will be assigned a single arm where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods.
Contingency management: Reinforcement, or incentives, in exchange for evidence of not drinking alcohol.
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|---|---|
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Feasibility Indicator of App Usage
First A Phase
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411 BAC samples actually submitted by phase
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Feasibility Indicator of App Usage
B Phase
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700 BAC samples actually submitted by phase
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Feasibility Indicator of App Usage
Second A Phase
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249 BAC samples actually submitted by phase
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SECONDARY outcome
Timeframe: 8 WeeksDuration in weeks of treatment retention
Outcome measures
| Measure |
Contingency Management A-B-A
n=12 Participants
All participants will be assigned a single arm where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods.
Contingency management: Reinforcement, or incentives, in exchange for evidence of not drinking alcohol.
|
|---|---|
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Treatment Retention
|
7.5 Weeks
Standard Deviation 1.1
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Adverse Events
First A Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
B Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Second A Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
First A Phase
n=12 participants at risk
All participants will be assigned a single arm within subject design, where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods. Participants were asked weekly about adverse events over the course of 8 weeks.
This arm reflects the 2 weeks in first A phase.
|
B Phase
n=12 participants at risk
All participants will be assigned a single arm within subject design, where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods. Participants were asked weekly about adverse events over the course of 8 weeks.
This arm reflects the 4 weeks in the experimental B phase.
|
Second A Phase
n=12 participants at risk
All participants will be assigned a single arm within subject design, where we will utilize an A-B-A, or return to baseline design where all participants will experience the intervention in between two baseline observation periods. Participants were asked weekly about adverse events over the course of 8 weeks.
This arm reflects the 2 weeks in the second A phase.
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|---|---|---|---|
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Renal and urinary disorders
Kidney Pain
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8.3%
1/12 • Number of events 1 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
0.00%
0/12 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
0.00%
0/12 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
|
Nervous system disorders
Mild headache
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8.3%
1/12 • Number of events 1 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
0.00%
0/12 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
0.00%
0/12 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
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0.00%
0/12 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
8.3%
1/12 • Number of events 1 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
0.00%
0/12 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
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0.00%
0/12 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
8.3%
1/12 • Number of events 1 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
0.00%
0/12 • 8 Weeks
Participants were asked once weekly at their visits about potential adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place