Interventions for Unemployed Hazardous Drinkers

Hazardous Drinking Clinical Trial

Official title:

Interventions for Unemployed Hazardous Drinkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559609
• Other study ID #: 15-041-2
• Secondary ID: R01AA023502
• Status: Completed
• Phase: N/A
• Start date: April 19, 2016
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2024
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hazardous Drinking
• Unemployment

Intervention

Behavioral:
• Contingency 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.
• Contingency management for completing job related activities
Participants will earn reinforcement (incentives) for completing specific job-related activities during the 12-week intervention period.
• Job relelated activity contracting
Participants will complete job-related activity contracts each week with the goal of obtaining employment.

Locations

Country	Name	City	State
United States	United Labor Agency	Middletown	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	12 weeks
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)	12 weeks
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)	12 weeks
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.	12 weeks
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	12 weeks
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	12 weeks