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Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder

Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03987581
Enrollment
151
Registered
2019-06-17
Start date
2019-11-26
Completion date
2024-11-18
Last updated
2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Veterans

Brief summary

Alcohol contributes to 88,000 deaths and costs an estimated $223 billion annually in the United States. Alcohol use disorder (AUD) is highly prevalent in veterans. The positive public health impact of reducing heavy drinking among veterans with AUD would prevent significant medical morbidity and mortality. Contingency management (CM) is an intensive behavioral therapy that provides incentives to individuals for reducing substance use. Monitoring alcohol abstinence usually requires daily monitoring. Because of this difficulty, CM approaches for treatment of AUD are not currently available to people with AUD. Our group has developed a mobile smart-phone application that allows patients to video themselves using an alcohol breath monitor and transmit the encrypted data to a secure server. This innovation has made the use of CM for outpatient AUD treatment feasible. The aim of the current study is to evaluate the effectiveness and cost effectiveness of CM as an add-on to cognitive behavioral therapy for AUD. The trial will also explore the potential usefulness of a long-term abstinence incentive ontreatment utilization and alcohol outcomes. Proposed is a trial in which 140 veterans with AUD will be randomized to receive either CM as an add-on to evidence-based CBT or CBT alone. Veterans will also be randomized to one of two long-term incentive conditions (i.e., receipt of a monetary incentive for abstinence/low-risk drinking at 6- months vs. no incentive). This project aims to advance AUD treatment by 1) testing the effectiveness of a mobile health approach that makes CM for AUD feasible, and 2) providing highly needed cost-effectiveness data on the use of behavioral incentives as an adjunct to CBT for the treatment of AUD. These aims are designed to address two significant barriers to the implementation of CM for AUD.

Interventions

BEHAVIORALCognitive Behavioral Therapy (CBT)

Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).

Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values.

BEHAVIORALLong-term incentive

This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* are an enrolled veteran at the DVAHCS for primary care, * have current AUD (meeting past month DSM-5 criteria), and * are willing to make a quit attempt and/or reduce alcohol use to low risk levels.

Exclusion criteria

* have fewer than 3 days of abstinence, * have a history of clinically significant alcohol withdrawal, as indicated by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA), or * are currently receiving professional behavioral treatment for AUD.

Design outcomes

Primary

MeasureTime frameDescription
Average Number of Heavy Drinking Days6-month post quit visitAt the 6-month follow-up visit, participants will self-report the number of heavy drinking (\> 5 drinks in day for men, \> 4 drinks in a day for women) days they have had in the past thirty days.

Secondary

MeasureTime frameDescription
Average Number of Binge Drinking Days6-month post quit visitParticipants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days.
Average Number of Drinking Days6-month post quit visitParticipants will self-report the number of drinking days in the past thirty days.
Average Number of Drinks Per Drinking Day6-month post quit visitParticipants will self-report the number of drinks on drinking days in the past 30 days.
Number of Participants With Self-reported Abstinence6-month post quit visitParticipants will self-report whether or not consumed any alcohol in the past 30 days.
Average Number of Heavy Drinking Days12-month post quit visitAt the 12-month follow-up visit, participants will self-report the number of heavy drinking (\> 5 drinks in day for men, \> 4 drinks in a day for women) days in the past thirty days.
Treatment Utilization as Measured by Number of Treatment Visits6-month post quit visitParticipants will provide self-report on use of adjunct treatments (e.g., Alcoholics Anonymous, group counseling) for alcohol use during the period between post-treatment and follow-ups. Where available, Department of Veterans Affairs administrative data will be used to determine enrollment or involvement in aftercare treatment.
Health Care Related Quality of Life12-month post quit visitHealth care related quality of life will be measured by the EuroQol.
CBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions CompletedPost-treatment, approximately 14 weeksThe number of cognitive behavioral therapy treatment sessions completed by each participant will be measured to determine treatment engagement
Incremental Cost-Effectiveness Ratio12-month post quit visitMeasure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator
Number of Participants With Bioverification of Low-risk Drinking6-month post quit visitParticipants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.

Countries

United States

Participant flow

Pre-assignment details

Eleven participants were deemed eligible to participate in the study but were not randomized. Seven voluntarily withdrew, and four were lost to contact.

Participants by arm

ArmCount
CBT + mCM + Incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment, mobile contingency management for alcohol abstinence, and a monetary incentive for 30-day abstinence at the 6-month follow-up. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values. Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date
35
CBT + mCM + no Incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values.
35
CBT Alone + Incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date
35
CBT Alone + no Incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).
35
Total140

Baseline characteristics

CharacteristicTotalCBT + mCM + IncentiveCBT + mCM + no IncentiveCBT Alone + IncentiveCBT Alone + no Incentive
Age, Continuous49 years
STANDARD_DEVIATION 13
48 years
STANDARD_DEVIATION 12
49 years
STANDARD_DEVIATION 14
50 years
STANDARD_DEVIATION 15
50 years
STANDARD_DEVIATION 12
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants3 Participants0 Participants3 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
132 Participants32 Participants35 Participants32 Participants33 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants0 Participants1 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
65 Participants17 Participants12 Participants21 Participants15 Participants
Race (NIH/OMB)
More than one race
3 Participants0 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
69 Participants18 Participants22 Participants12 Participants17 Participants
Region of Enrollment
United States
140 Participants35 Participants35 Participants35 Participants35 Participants
Sex/Gender, Customized
Sex
Female
27 Participants6 Participants7 Participants7 Participants7 Participants
Sex/Gender, Customized
Sex
Male
112 Participants29 Participants27 Participants28 Participants28 Participants
Sex/Gender, Customized
Sex
Unknown, not reported
1 Participants0 Participants1 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 350 / 350 / 35
other
Total, other adverse events
2 / 354 / 353 / 351 / 35
serious
Total, serious adverse events
0 / 350 / 350 / 350 / 35

Outcome results

Primary

Average Number of Heavy Drinking Days

At the 6-month follow-up visit, participants will self-report the number of heavy drinking (\> 5 drinks in day for men, \> 4 drinks in a day for women) days they have had in the past thirty days.

Time frame: 6-month post quit visit

Population: Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveAverage Number of Heavy Drinking Days15.1 daysStandard Deviation 12.2
CBT + mCM + no IncentiveAverage Number of Heavy Drinking Days15.9 daysStandard Deviation 10
CBT Alone + IncentiveAverage Number of Heavy Drinking Days13.2 daysStandard Deviation 11.2
CBT Alone + no IncentiveAverage Number of Heavy Drinking Days11.3 daysStandard Deviation 11.2
Secondary

Average Number of Binge Drinking Days

Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days.

Time frame: 12-month post quit visit

Population: Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveAverage Number of Binge Drinking Days0.5 daysStandard Deviation 1.5
CBT + mCM + no IncentiveAverage Number of Binge Drinking Days0.7 daysStandard Deviation 2.8
CBT Alone + IncentiveAverage Number of Binge Drinking Days0.8 daysStandard Deviation 3.4
CBT Alone + no IncentiveAverage Number of Binge Drinking Days4.0 daysStandard Deviation 10.5
Secondary

Average Number of Binge Drinking Days

Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days.

Time frame: 6-month post quit visit

Population: Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveAverage Number of Binge Drinking Days0.9 daysStandard Deviation 4.8
CBT + mCM + no IncentiveAverage Number of Binge Drinking Days3.4 daysStandard Deviation 7.6
CBT Alone + IncentiveAverage Number of Binge Drinking Days1.8 daysStandard Deviation 6.5
CBT Alone + no IncentiveAverage Number of Binge Drinking Days2.2 daysStandard Deviation 6.7
Secondary

Average Number of Drinking Days

Participants will self-report the number of drinking days in the past thirty days.

Time frame: 6-month post quit visit

Population: Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveAverage Number of Drinking Days11.0 daysStandard Deviation 10.2
CBT + mCM + no IncentiveAverage Number of Drinking Days12.2 daysStandard Deviation 11.6
CBT Alone + IncentiveAverage Number of Drinking Days7.9 daysStandard Deviation 9.3
CBT Alone + no IncentiveAverage Number of Drinking Days9.6 daysStandard Deviation 10.7
Secondary

Average Number of Drinking Days

Participants will self-report the number of drinking days in the past thirty days.

Time frame: 12-month post quit visit

Population: Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveAverage Number of Drinking Days10.5 daysStandard Deviation 10.4
CBT + mCM + no IncentiveAverage Number of Drinking Days8.0 daysStandard Deviation 9.8
CBT Alone + IncentiveAverage Number of Drinking Days8.1 daysStandard Deviation 9.9
CBT Alone + no IncentiveAverage Number of Drinking Days12.3 daysStandard Deviation 11
Secondary

Average Number of Drinks Per Drinking Day

Participants will self-report the number of drinks on drinking days in the past 30 days.

Time frame: 12-month post quit visit

Population: Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveAverage Number of Drinks Per Drinking Day3.5 drinksStandard Deviation 3.7
CBT + mCM + no IncentiveAverage Number of Drinks Per Drinking Day2.3 drinksStandard Deviation 2.5
CBT Alone + IncentiveAverage Number of Drinks Per Drinking Day3.2 drinksStandard Deviation 2.8
CBT Alone + no IncentiveAverage Number of Drinks Per Drinking Day2.8 drinksStandard Deviation 2
Secondary

Average Number of Drinks Per Drinking Day

Participants will self-report the number of drinks on drinking days in the past 30 days.

Time frame: 6-month post quit visit

Population: Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveAverage Number of Drinks Per Drinking Day3.4 drinksStandard Deviation 3.8
CBT + mCM + no IncentiveAverage Number of Drinks Per Drinking Day3.2 drinksStandard Deviation 3.3
CBT Alone + IncentiveAverage Number of Drinks Per Drinking Day2.5 drinksStandard Deviation 2
CBT Alone + no IncentiveAverage Number of Drinks Per Drinking Day2.0 drinksStandard Deviation 2.1
Secondary

Average Number of Heavy Drinking Days

At the 12-month follow-up visit, participants will self-report the number of heavy drinking (\> 5 drinks in day for men, \> 4 drinks in a day for women) days in the past thirty days.

Time frame: 12-month post quit visit

Population: Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveAverage Number of Heavy Drinking Days2.8 daysStandard Deviation 7
CBT + mCM + no IncentiveAverage Number of Heavy Drinking Days1.2 daysStandard Deviation 3.1
CBT Alone + IncentiveAverage Number of Heavy Drinking Days2.4 daysStandard Deviation 6.5
CBT Alone + no IncentiveAverage Number of Heavy Drinking Days4.5 daysStandard Deviation 10.4
Secondary

CBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed

The number of cognitive behavioral therapy treatment sessions completed by each participant will be measured to determine treatment engagement

Time frame: Post-treatment, approximately 14 weeks

Population: Two participants were withdrawn from analyses due to missing data.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveCBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed10.4 CBT sessionsStandard Deviation 2.9
CBT + mCM + no IncentiveCBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed9.6 CBT sessionsStandard Deviation 3.3
CBT Alone + IncentiveCBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed9.1 CBT sessionsStandard Deviation 3.8
CBT Alone + no IncentiveCBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed9.3 CBT sessionsStandard Deviation 3.9
Secondary

Health Care Related Quality of Life

Health care related quality of life will be measured by the EuroQol.

Time frame: 12-month post quit visit

Secondary

Incremental Cost-Effectiveness Ratio

Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator

Time frame: 12-month post quit visit

Secondary

Number of Participants With Bioverification of Low-risk Drinking

Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.

Time frame: 12-month post quit visit

Population: Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit. Additionally, 4 participants failed to send in their PEth test kits for analysis.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CBT + mCM + IncentiveNumber of Participants With Bioverification of Low-risk Drinking4 Participants
CBT + mCM + no IncentiveNumber of Participants With Bioverification of Low-risk Drinking13 Participants
CBT Alone + IncentiveNumber of Participants With Bioverification of Low-risk Drinking9 Participants
CBT Alone + no IncentiveNumber of Participants With Bioverification of Low-risk Drinking6 Participants
Secondary

Number of Participants With Bioverification of Low-risk Drinking

Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks.

Time frame: 6-month post quit visit

Population: Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit. Additionally, 7 participants failed to send in their PEth test kits for analysis.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CBT + mCM + IncentiveNumber of Participants With Bioverification of Low-risk Drinking13 Participants
CBT + mCM + no IncentiveNumber of Participants With Bioverification of Low-risk Drinking7 Participants
CBT Alone + IncentiveNumber of Participants With Bioverification of Low-risk Drinking13 Participants
CBT Alone + no IncentiveNumber of Participants With Bioverification of Low-risk Drinking9 Participants
Secondary

Number of Participants With Self-reported Abstinence

Participants will self-report whether or not consumed any alcohol in the past 30 days.

Time frame: 12-month post quit visit

Population: Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CBT + mCM + IncentiveNumber of Participants With Self-reported Abstinence5 Participants
CBT + mCM + no IncentiveNumber of Participants With Self-reported Abstinence8 Participants
CBT Alone + IncentiveNumber of Participants With Self-reported Abstinence5 Participants
CBT Alone + no IncentiveNumber of Participants With Self-reported Abstinence3 Participants
Secondary

Number of Participants With Self-reported Abstinence

Participants will self-report whether or not consumed any alcohol in the past 30 days.

Time frame: 6-month post quit visit

Population: Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CBT + mCM + IncentiveNumber of Participants With Self-reported Abstinence5 Participants
CBT + mCM + no IncentiveNumber of Participants With Self-reported Abstinence6 Participants
CBT Alone + IncentiveNumber of Participants With Self-reported Abstinence10 Participants
CBT Alone + no IncentiveNumber of Participants With Self-reported Abstinence5 Participants
Secondary

Treatment Utilization as Measured by Number of Treatment Visits

Participants will provide self-report on use of adjunct treatments (e.g., Alcoholics Anonymous, group counseling) for alcohol use during the period between post-treatment and follow-ups. Where available, Department of Veterans Affairs administrative data will be used to determine enrollment or involvement in aftercare treatment.

Time frame: 6-month post quit visit

Population: 29 participants were withdrawn from analyses due to missing data.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveTreatment Utilization as Measured by Number of Treatment Visits0.03 treatment visitsStandard Deviation 0.2
CBT + mCM + no IncentiveTreatment Utilization as Measured by Number of Treatment Visits1.5 treatment visitsStandard Deviation 4.5
CBT Alone + IncentiveTreatment Utilization as Measured by Number of Treatment Visits2.1 treatment visitsStandard Deviation 5.2
CBT Alone + no IncentiveTreatment Utilization as Measured by Number of Treatment Visits0.2 treatment visitsStandard Deviation 0.7
Secondary

Treatment Utilization as Measured by Number of Treatment Visits

Participants will provide self-report on use of adjunct treatments (e.g., Alcoholics Anonymous, group counseling) for alcohol use during the period between post-treatment and follow-ups. Where available, Department of Veterans Affairs administrative data will be used to determine enrollment or involvement in aftercare treatment.

Time frame: 12-month post quit visit

Population: 31 participants were withdrawn from analyses due to missing data.

ArmMeasureValue (MEAN)Dispersion
CBT + mCM + IncentiveTreatment Utilization as Measured by Number of Treatment Visits0.6 treatment visitsStandard Deviation 1.6
CBT + mCM + no IncentiveTreatment Utilization as Measured by Number of Treatment Visits8.2 treatment visitsStandard Deviation 29.5
CBT Alone + IncentiveTreatment Utilization as Measured by Number of Treatment Visits2.9 treatment visitsStandard Deviation 8.9
CBT Alone + no IncentiveTreatment Utilization as Measured by Number of Treatment Visits0.3 treatment visitsStandard Deviation 1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026