CClinicalTrials.gg
CompletedNCT02559609Updated Apr 23, 2024Results posted

Interventions for Unemployed Hazardous Drinkers

An interventional study of Contingency management for alcohol abstinence and Contingency management for completing job related activities in Unemployment and Hazardous Drinking, sponsored by UConn Health. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by UConn Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Unemployment
  • Hazardous Drinking
03

In context

Lead sponsor

UConn Health is the lead sponsor of 182 studies on the registry; 18 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • Active comparator
    job activity contracting

    Standard services plus job activity contracting and alcohol monitoring

    Behavioral: Job relelated activity contracting

  • Experimental
    reinforcement for negative alcohol samples

    Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings

    Behavioral: Contingency management for alcohol abstinence · Behavioral: Job relelated activity contracting

  • Experimental
    reinforcement for completing activities

    Standard services plus job activity contracting and alcohol monitoring plus reinforcement for completing job-related activities

    Behavioral: Contingency management for completing job related activities · Behavioral: Job relelated activity contracting

  • Experimental
    reinforcement for negative alcohol samples & activities

    Standard services plus job activity contracting and alcohol monitoring plus reinforcement for negative breath alcohol recordings and for completing job-related activities

    Behavioral: Contingency management for alcohol abstinence · Behavioral: Contingency management for completing job related activities · Behavioral: Job relelated activity contracting

Interventions

  • 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.

  • BehavioralContingency management for completing job related activities

    Participants will earn reinforcement (incentives) for completing specific job-related activities 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

07

Results

Posted Jun 22, 2023

Participant flow

Participant flow — Overall Study
MilestoneGroup 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 Activities
Started50655867
Completed50645867
Not completed0100

Outcome measures

PrimaryLongest 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
Reported as:
Median · number of alcohol negative breath tests
Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure)
number of alcohol negative breath testsGroup 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 Activities
Longest Duration of Alcohol Abstinence (Samples) (Physiological Measure)6.0 (3.0 to 14.0)11.0 (5.0 to 26.0)7.0 (4.0 to 17.3)7.5 (5.0 to 18.3)
Statistical analysis
  • Group A - Standard Job Activity Contracting and Alcohol Monitoring vs Group B - Reinforcement for Negative Alcohol Samples vs Group C - Reinforcement for Completing Job Activities vs Group D - Reinforcement for Negative Alcohol Samples & Job Activities · Wilcoxon (Mann-Whitney) · p = .028
PrimaryPercent 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
Reported as:
Mean · percentage of alcohol negative tests
Percent Alcohol Negative Breath Tests
percentage of alcohol negative testsGroup 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 Activities
Percent Alcohol Negative Breath Tests90.8 (48.9 to 100.0)98.1 (78.9 to 100.00)91.2 (66.6 to 100.0)97.1 (67.0 to 100.0)
Statistical analysis
  • Group A - Standard Job Activity Contracting and Alcohol Monitoring vs Group B - Reinforcement for Negative Alcohol Samples vs Group C - Reinforcement for Completing Job Activities vs Group D - Reinforcement for Negative Alcohol Samples & Job Activities · Wilcoxon (Mann-Whitney) · p = .027
PrimaryPercent 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
Reported as:
Median · percentage of days work occurred
Percent of Days Worked for Pay (Missing Data Treated as Missing)
percentage of days work occurredGroup 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 Activities
Percent of Days Worked for Pay (Missing Data Treated as Missing)1.79 (0.00 to 22.99)4.76 (0.00 to 24.40)6.25 (0.00 to 25.77)1.33 (0.00 to 26.19)
Statistical analysis
  • Group A - Standard Job Activity Contracting and Alcohol Monitoring vs Group B - Reinforcement for Negative Alcohol Samples vs Group C - Reinforcement for Completing Job Activities vs Group D - Reinforcement for Negative Alcohol Samples & Job Activities · ANOVA · p = .66df = 1
PrimaryTime 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
Reported as:
Median · days
Time to First Worked
daysGroup 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 Activities
Time to First Worked79.50 (15.00 to 85.0)57.00 (24.00 to 85.0)63.00 (16.50 to 85.0)63.00 (16.00 to 85.0)
Statistical analysis
  • Group A - Standard Job Activity Contracting and Alcohol Monitoring vs Group B - Reinforcement for Negative Alcohol Samples vs Group C - Reinforcement for Completing Job Activities vs Group D - Reinforcement for Negative Alcohol Samples & Job Activities · Regression, Cox · p = .89
SecondaryPercent 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
Reported as:
Median · percentage of days work occurred
Percent of Days Worked for Pay (84 Day Intervention Period in the Denominator)
percentage of days work occurredGroup 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 Activities
Percent of Days Worked for Pay (84 Day Intervention Period in the Denominator)1.19 (0.00 to 18.15)4.17 (0.00 to 22.02)4.76 (0.00 to 23.81)1.19 (0.00 to 22.62)
Statistical analysis
  • Group A - Standard Job Activity Contracting and Alcohol Monitoring vs Group B - Reinforcement for Negative Alcohol Samples vs Group C - Reinforcement for Completing Job Activities vs Group D - Reinforcement for Negative Alcohol Samples & Job Activities · ANOVA · p = .58df = 1
SecondaryLongest 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
Reported as:
Median · days
Longest Duration of Alcohol Abstinence (Days) (Physiological Measure)
daysGroup 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 Activities
Longest Duration of Alcohol Abstinence (Days) (Physiological Measure)4.0 (2.0 to 10.0)9.0 (3.0 to 19.0)5.0 (3.0 to 12.3)6.0 (3.0 to 13.5)
Statistical analysis
  • Group A - Standard Job Activity Contracting and Alcohol Monitoring vs Group B - Reinforcement for Negative Alcohol Samples vs Group C - Reinforcement for Completing Job Activities vs Group D - Reinforcement for Negative Alcohol Samples & Job Activities · Wilcoxon (Mann-Whitney) · p = .024

Adverse events

Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group A - Standard Job Activity Contracting and Alcohol Monitoring0/50 (0%)6/50 (12%)5/50 (10%)
Group B - Reinforcement for Negative Alcohol Samples0/65 (0%)8/65 (12.3%)5/65 (7.7%)
Group C - Reinforcement for Completing Job Activities1/58 (1.7%)9/58 (15.5%)1/58 (1.7%)
Group D - Reinforcement for Negative Alcohol Samples & Job Activities0/67 (0%)9/67 (13.4%)6/67 (9%)
Most frequent serious events
Most frequent serious events
EventGroup 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 Activities
Inpatient substance use treatmentGeneral disorders3/503/655/586/67
Inpatient medical treatmentGeneral disorders2/504/654/584/67
Inpatient psychiatric treatmentPsychiatric disorders1/501/652/581/67
Most frequent other events
Most frequent other events
EventGroup 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 Activities
Emergency Room VisitGeneral disorders5/505/651/586/67

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group 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
<=18 years00000
Between 18 and 65 years50655867240
>=65 years00000
Age, Continuous
Age, Continuous(years)Group 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
Mean46.10 ± 9.7745.94 ± 11.3442.38 ± 10.8946.37 ± 10.0645.23 ± 10.63
Sex: Female, Male
Sex: Female, Male(Participants)Group 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
Female17343035116
Male33312832124
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 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
Hispanic or Latino4781029
Not Hispanic or Latino46585057211
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 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
American Indian or Alaska Native11002
Asian00000
Native Hawaiian or Other Pacific Islander10001
Black or African American29372536127
White19243128102
More than one race02002
Unknown or Not Reported01236
Region of Enrollment
Region of Enrollment(participants)Group 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
United States50655867240
08

Study locations

1 site
  • United Labor Agency
    Middletown, Connecticut 06457, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 15, 2021
  • Informed consent form · Apr 29, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02559609
Lead sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Carla Rash (Assistant Professor, UConn Health) — Principal investigator
First posted
Sep 24, 2015
Start date
Apr 19, 2016
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Results posted
Jun 22, 2023
Last update
Apr 23, 2024

Study contacts

Carla J Rash, Ph.D.
principal investigator · UConn Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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