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Interventions for Unemployed Hazardous Drinkers

Interventions for Unemployed Hazardous Drinkers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02559609
Enrollment
240
Registered
2015-09-24
Start date
2016-04-19
Completion date
2022-06-01
Last updated
2024-04-23

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

Conditions

Hazardous Drinking, Unemployment

Brief summary

Despite recent improvements in the US economy, unemployment remains a significant concern, and estimates indicate that one-third of unemployed persons drink at hazardous levels, adversely impacting their health and abilities to find jobs. Reinforcement interventions are highly efficacious in reducing substance use, and they can be applied to increase job-seeking activities as well. In partnership with CT United Labor Agency, this project is designed to reduce hazardous drinking and enhance active participation in job-seeking activities among those with job loss. It will evaluate the independent and combined effects of reinforcing negative breathalyzer samples and job-seeking activities to ascertain the simplest and most cost-effective approach to improving outcomes in this population. Unemployed individuals with hazardous drinking (N = 280) will be randomly assigned to one of four conditions using a 2 x 2 design: standard care, standard care with reinforcement for submitting negative breathalyzer samples, standard care with reinforcement for job-seeking activities, or standard care plus reinforcement for both negative breathalyzer samples and job-seeking activities. Participants in all conditions will receive usual services part of CT United Labor Agency, along with a novel remote breath alcohol monitoring procedure. The study interventions will be in effect for three months, and participants will be followed for one year. Alcohol and other drug use, employment, psychiatric symptoms, and global measures of health will be assessed throughout treatment and follow-up. Reinforcing negative breathalyzer samples is expected to significantly reduce drinking, and reinforcing job-seeking activities is expected to increase re-employment rates and reduce time until job attainment. Reinforcing both negative breathalyzer samples and job-seeking activities is hypothesized to improve outcomes along both domains. The reinforcement interventions may also decrease psychiatric distress and slow progression of physical decline, common among the unemployed. If efficacious and cost-effective, results from this study may stimulate adoption of reinforcement interventions in the context of unemployment services. Reducing the adverse consequences of hazardous drinking and improving job re-entry may have pronounced benefits in a highly vulnerable segment of the US population.

Interventions

BEHAVIORALContingency management for completing job related activities

Participants will earn reinforcement (incentives) for completing specific job-related activities during the 12-week intervention period.

BEHAVIORALContingency management for alcohol abstinence

Participants will earn reinforcement (incentives) for each alcohol negative breath test provided (when prompted to submit a test) during the 12-week intervention period.

BEHAVIORALJob relelated activity contracting

Participants will complete job-related activity contracts each week with the goal of obtaining employment.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
UConn Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* age 18-65 years * not worked for pay in the formal economy for \>4 weeks * willing to participate in a workforce training program and willing to accept either part-time or full-time work * hazardous alcohol use defined by AUDIT scores \>8, a mean of \>2 drinks/drinking day or \>14 drinks/week in men (\>1 drink/drinking day or \>7 drinks/week in women) in the past 2 months, or submission of an alcohol positive breathalyzer (\>0.02 g/dl) or EtG positive urine sample * English or Spanish speaking and able to read at 5th grade level * have a valid photo ID * willing and able to use study equipment and sign an off-campus property transfer form

Exclusion criteria

* have begun receiving unemployment benefits within the past 4 weeks * worked full- or part-time \<3 months in the past 3 years in the formal or informal economy * physiological alcohol withdrawal symptoms (score \>10 on Clinical Institute Withdrawal Assessment for Alcohol-revised) * physiological withdrawal symptoms from an illicit drug use disorder * serious untreated psychiatric illness * in recovery from gambling disorder

Design outcomes

Primary

MeasureTime frameDescription
Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure)12 weeksGreatest number of consecutive breath tests submitted on-time (within 1 hour of prompt) and reading alcohol negative (BAL \< 0.02)
Percent Alcohol Negative Breath Tests12 weeksOf alcohol breath tests requested, the percentage submitted on-time (within 1-hour of prompt) and reading alcohol-negative (BAL \< .02)
Percent of Days Worked for Pay (Missing Data Treated as Missing)12 weeksThe percentage of days of work for pay (in the formal or informal economy), with the number of days of data in the denominator (missing data considered missing)
Time to First Worked12 weeksFrom study day 1, the number of days until first worked in the formal or informal economy during the 12-week intervention, censored at day 85.

Secondary

MeasureTime frameDescription
Percent of Days Worked for Pay (84 Day Intervention Period in the Denominator)12 weeksThe percent of days worked for pay (in the formal or informal economy), with 84 days (intervention period duration; missing treated as not working) in the denominator
Longest Duration of Alcohol Abstinence (Days) (Physiological Measure)12 weeksGreatest number of consecutive days of submitting all breath tests requested on-time and reading alcohol negative

Countries

United States

Participant flow

Participants by arm

ArmCount
Group A - Standard Job Activity Contracting and Alcohol Monitoring
Standard services plus job activity contracting and alcohol monitoring activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
50
Group B - Reinforcement for Negative Alcohol Samples
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment
65
Group C - Reinforcement for Completing Job Activities
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities activity contracting: participants will complete job-related activity contracts each week with the goal of obtaining employment contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
58
Group D - Reinforcement for Negative Alcohol Samples & Job Activities
Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities contingency management for alcohol abstinence: participants will earn chances to win prizes for each negative breath alcohol recording provided contingency management for activity completion: participants will earn chances to win prizes for completing specific job-related activities
67
Total240

Baseline characteristics

CharacteristicGroup A - Standard Job Activity Contracting and Alcohol MonitoringGroup B - Reinforcement for Negative Alcohol SamplesGroup C - Reinforcement for Completing Job ActivitiesGroup D - Reinforcement for Negative Alcohol Samples & Job ActivitiesTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
50 Participants65 Participants58 Participants67 Participants240 Participants
Age, Continuous46.10 years
STANDARD_DEVIATION 9.77
45.94 years
STANDARD_DEVIATION 11.34
42.38 years
STANDARD_DEVIATION 10.89
46.37 years
STANDARD_DEVIATION 10.06
45.23 years
STANDARD_DEVIATION 10.63
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants7 Participants8 Participants10 Participants29 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants58 Participants50 Participants57 Participants211 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
29 Participants37 Participants25 Participants36 Participants127 Participants
Race (NIH/OMB)
More than one race
0 Participants2 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants2 Participants3 Participants6 Participants
Race (NIH/OMB)
White
19 Participants24 Participants31 Participants28 Participants102 Participants
Region of Enrollment
United States
50 participants65 participants58 participants67 participants240 participants
Sex: Female, Male
Female
17 Participants34 Participants30 Participants35 Participants116 Participants
Sex: Female, Male
Male
33 Participants31 Participants28 Participants32 Participants124 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 / 500 / 651 / 580 / 67
other
Total, other adverse events
5 / 505 / 651 / 586 / 67
serious
Total, serious adverse events
6 / 508 / 659 / 589 / 67

Outcome results

Primary

Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure)

Greatest number of consecutive breath tests submitted on-time (within 1 hour of prompt) and reading alcohol negative (BAL \< 0.02)

Time frame: 12 weeks

Population: N=234 analyzed. n=6 with no data: n=1 Group B withdrawal; n=5 had no samples submitted (n=1 Group A, n=1 Group B, n=1 group D) or none submitted on-time (n=2 Group B).

ArmMeasureValue (MEDIAN)
Group A - Standard Job Activity Contracting and Alcohol MonitoringLongest Duration of Alcohol Abstinence (Samples) (Physiological Measure)6.0 number of alcohol negative breath tests
Group B - Reinforcement for Negative Alcohol SamplesLongest Duration of Alcohol Abstinence (Samples) (Physiological Measure)11.0 number of alcohol negative breath tests
Group C - Reinforcement for Completing Job ActivitiesLongest Duration of Alcohol Abstinence (Samples) (Physiological Measure)7.0 number of alcohol negative breath tests
Group D - Reinforcement for Negative Alcohol Samples & Job ActivitiesLongest Duration of Alcohol Abstinence (Samples) (Physiological Measure)7.5 number of alcohol negative breath tests
Comparison: Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1p-value: 0.028Wilcoxon (Mann-Whitney)
Primary

Percent Alcohol Negative Breath Tests

Of alcohol breath tests requested, the percentage submitted on-time (within 1-hour of prompt) and reading alcohol-negative (BAL \< .02)

Time frame: 12 weeks

Population: N=234 analyzed. n=6 with no data: n=1 Group B withdrawal; n=5 had no samples submitted (n=1 Group A, n=1 Group B, n=1 group D) or none submitted on-time (n=2 Group B).

ArmMeasureValue (MEAN)
Group A - Standard Job Activity Contracting and Alcohol MonitoringPercent Alcohol Negative Breath Tests90.8 percentage of alcohol negative tests
Group B - Reinforcement for Negative Alcohol SamplesPercent Alcohol Negative Breath Tests98.1 percentage of alcohol negative tests
Group C - Reinforcement for Completing Job ActivitiesPercent Alcohol Negative Breath Tests91.2 percentage of alcohol negative tests
Group D - Reinforcement for Negative Alcohol Samples & Job ActivitiesPercent Alcohol Negative Breath Tests97.1 percentage of alcohol negative tests
Comparison: Group A/C (contrast -1) compared to Group B/D (contrast 1)p-value: 0.027Wilcoxon (Mann-Whitney)
Primary

Percent of Days Worked for Pay (Missing Data Treated as Missing)

The percentage of days of work for pay (in the formal or informal economy), with the number of days of data in the denominator (missing data considered missing)

Time frame: 12 weeks

Population: N=228, n=12 no score: n=1 Group B withdrawal; n=1 Group D on disability (no working allowed); no data for n= 2 Group A, n=4 Group B, n=1 Group C, n=3 Group D

ArmMeasureValue (MEDIAN)
Group A - Standard Job Activity Contracting and Alcohol MonitoringPercent of Days Worked for Pay (Missing Data Treated as Missing)1.79 percentage of days work occurred
Group B - Reinforcement for Negative Alcohol SamplesPercent of Days Worked for Pay (Missing Data Treated as Missing)4.76 percentage of days work occurred
Group C - Reinforcement for Completing Job ActivitiesPercent of Days Worked for Pay (Missing Data Treated as Missing)6.25 percentage of days work occurred
Group D - Reinforcement for Negative Alcohol Samples & Job ActivitiesPercent of Days Worked for Pay (Missing Data Treated as Missing)1.33 percentage of days work occurred
Comparison: Group A/B (contrast -1) was compared to Group C/D (contrast 1) to test Aim 2.p-value: 0.66ANOVA
Primary

Time to First Worked

From study day 1, the number of days until first worked in the formal or informal economy during the 12-week intervention, censored at day 85.

Time frame: 12 weeks

Population: N=228 analyzed. n=12 no score: n=1 Group B withdrawal; n=1 Group D on disability (no working allowed); no data for n= 2 Group A, n=4 Group B, n=1 Group C, n=3 Group D

ArmMeasureValue (MEDIAN)
Group A - Standard Job Activity Contracting and Alcohol MonitoringTime to First Worked79.50 days
Group B - Reinforcement for Negative Alcohol SamplesTime to First Worked57.00 days
Group C - Reinforcement for Completing Job ActivitiesTime to First Worked63.00 days
Group D - Reinforcement for Negative Alcohol Samples & Job ActivitiesTime to First Worked63.00 days
Comparison: Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.p-value: 0.89Regression, Cox
Secondary

Longest Duration of Alcohol Abstinence (Days) (Physiological Measure)

Greatest number of consecutive days of submitting all breath tests requested on-time and reading alcohol negative

Time frame: 12 weeks

ArmMeasureValue (MEDIAN)
Group A - Standard Job Activity Contracting and Alcohol MonitoringLongest Duration of Alcohol Abstinence (Days) (Physiological Measure)4.0 days
Group B - Reinforcement for Negative Alcohol SamplesLongest Duration of Alcohol Abstinence (Days) (Physiological Measure)9.0 days
Group C - Reinforcement for Completing Job ActivitiesLongest Duration of Alcohol Abstinence (Days) (Physiological Measure)5.0 days
Group D - Reinforcement for Negative Alcohol Samples & Job ActivitiesLongest Duration of Alcohol Abstinence (Days) (Physiological Measure)6.0 days
Comparison: Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1.p-value: 0.024Wilcoxon (Mann-Whitney)
Secondary

Percent of Days Worked for Pay (84 Day Intervention Period in the Denominator)

The percent of days worked for pay (in the formal or informal economy), with 84 days (intervention period duration; missing treated as not working) in the denominator

Time frame: 12 weeks

Population: N=228 analyzed. n=12 no score: n=1 Group B withdrawal; n=1 Group D on disability (no working allowed); no data for n= 2 Group A, n=4 Group B, n=1 Group C, n=3 Group D

ArmMeasureValue (MEDIAN)
Group A - Standard Job Activity Contracting and Alcohol MonitoringPercent of Days Worked for Pay (84 Day Intervention Period in the Denominator)1.19 percentage of days work occurred
Group B - Reinforcement for Negative Alcohol SamplesPercent of Days Worked for Pay (84 Day Intervention Period in the Denominator)4.17 percentage of days work occurred
Group C - Reinforcement for Completing Job ActivitiesPercent of Days Worked for Pay (84 Day Intervention Period in the Denominator)4.76 percentage of days work occurred
Group D - Reinforcement for Negative Alcohol Samples & Job ActivitiesPercent of Days Worked for Pay (84 Day Intervention Period in the Denominator)1.19 percentage of days work occurred
Comparison: Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.p-value: 0.58ANOVA

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