NCT02499913

Brief Summary

Alcohol use and alcohol-related disorders are highly prevalent in soup kitchen users, and this population is overrepresented by minorities and disproportionately affected by alcohol-related morbidity and mortality. Contingency management is a behavioral intervention effective in reducing substance use, but few studies have evaluated the efficacy of contingency management in the context of soup kitchens or homeless programs. The investigators found that contingency management, using a twice weekly testing and reinforcement schedule, had benefits for decreasing drinking in individuals receiving services at a homeless shelter. This study will replicate and extend these earlier findings to a soup kitchen population using more sophisticated alcohol monitoring procedures to better assess the extent of drinking in this group and in response to a contingency management intervention reinforcing submission of negative breath samples. Specifically, 40 hazardous drinkers recruited from a soup kitchen will be randomly assigned to one of two conditions: alcohol monitoring or the same plus reinforcement for provision of daily negative breath alcohol samples. The interventions will be in effect for 3 weeks, and all participants will also wear transdermal continuous alcohol monitors during the intervention period. Objective and subjective indices of alcohol consumption will be evaluated and compared between and within the treatment conditions. This pilot project will provide information regarding the effect size of contingency management reinforcing negative breath samples in an important health disparities group, and results from this study will guide subsequent grant applications focusing on methods to decrease drinking in this underserved population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

July 14, 2015

Last Update Submit

June 22, 2017

Conditions

Alcohol AbuseContingency Management

Outcome Measures

Primary Outcomes (1)

  • efficacy of contingency management relative to monitoring only

    longest duration of abstinence

    week 4

Study Arms (2)

breath alcohol monitoring

ACTIVE COMPARATOR

Breath alcohol samples and self-reports of drinking will be collected once daily at lunch and will be used as objective indicators of recent alcohol use.

Behavioral: breath alcohol monitoring

breath monitoring plus prize contingency management

EXPERIMENTAL

Breath alcohol samples and self-reports of drinking will be collected once daily at lunch and will be used as objective indicators of recent alcohol use. Participants of this group earn opportunities to draw cards from a prize bowl for negative breath samples.

Behavioral: breath alcohol monitoringBehavioral: contingency management

Interventions

breath alcohol monitoringBEHAVIORAL

Daily breath alcohol monitoring

breath alcohol monitoringbreath monitoring plus prize contingency management
contingency managementBEHAVIORAL

Participants can earn chance to win prizes for negative breath alcohol samples.

breath monitoring plus prize contingency management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥18
  • frequent soup kitchen users who drink alcohol
  • willing to wear transdermal alcohol monitor for 3 weeks
  • willing to sign a property transfer form and return SCRAMx equipment

You may not qualify if:

  • uncontrolled, severe psychopathology and/or severe cognitive impairment
  • non-English speaking
  • in recovery for pathological gambling
  • has a medical condition that would interfere with transdermal alcohol readings
  • legal charges pending that are likely to lead to incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friendship Center

New Britain, Connecticut, 06051, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Carla Rash, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 16, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 26, 2017

Record last verified: 2017-06

Locations

US(1)