- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02499913
Contingency Management to Reduce Alcohol Use in a Soup Kitchen Sample (SK)
June 22, 2017 updated by: Carla Rash, UConn Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Britain, Connecticut, United States, 06051
- Friendship Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: breath alcohol monitoring
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.
|
Daily breath alcohol monitoring
|
|
Experimental: breath monitoring plus prize contingency management
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.
|
Daily breath alcohol monitoring
Participants can earn chance to win prizes for negative breath alcohol samples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
efficacy of contingency management relative to monitoring only
Time Frame: week 4
|
longest duration of abstinence
|
week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Carla Rash, Ph.D., UConn Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
July 14, 2015
First Submitted That Met QC Criteria
July 14, 2015
First Posted (Estimate)
July 16, 2015
Study Record Updates
Last Update Posted (Actual)
June 26, 2017
Last Update Submitted That Met QC Criteria
June 22, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-177-1
- P60AA003510 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Contingency Management
-
University of VirginiaNot yet recruitingContingency Management | Stimulant Use
-
UConn HealthNational Institute on Drug Abuse (NIDA)CompletedContingency Management | Cocaine Use DisorderUnited States
-
Queen's Medical CenterNot yet recruitingWhy Wait? Initiating Contingency Management in Traumatically Injured Patients During HospitalizationContingency Management | Methamphetamine Use DisorderUnited States
-
University of OklahomaEnrolling by invitationTobacco Cessation | Tobacco Use | Tobacco Smoking | Smoking Cessation Financial Incentives | Socioeconomic Status | Contingency Management | PregnancyUnited States
-
UConn HealthNational Heart, Lung, and Blood Institute (NHLBI)CompletedWeight Loss | Contingency ManagementUnited States
-
UConn HealthNational Institute on Minority Health and Health Disparities (NIMHD)CompletedContingency Management | HIV | HIV Testing | WomenUnited States
-
UConn HealthNational Institute on Drug Abuse (NIDA)CompletedContingency Management | Exercise | Substance AbuseUnited States
-
UConn HealthNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedContingency Management | Alcohol Use DisorderUnited States
-
UConn HealthNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedContingency Management | Alcohol Use DisorderUnited States
-
Washington University School of MedicineNational Institute on Drug Abuse (NIDA)RecruitingContingency Management | Pregnancy | Postpartum | Substance Use Disorder (SUD)United States
Clinical Trials on breath alcohol monitoring
-
Trabzon UniversityCompletedHealthy Adult MaleTurkey (Türkiye)
-
Centre d'Investigation Clinique et Technologique...Adep AssistanceTerminatedRespiratory FailureFrance
-
Masonic Cancer Center, University of MinnesotaNational Institutes of Health (NIH)RecruitingFanconi Anemia | Oral Cavity Carcinoma | Alcohol-Related CarcinomaUnited States
-
St. Luke's Hospital and Health Network, PennsylvaniaCompletedAlcohol IntoxicationUnited States
-
University of PennsylvaniaCompletedAlcohol Drinking | Drinking Behavior | Perception, Self | Drinking, Alcohol | Alcohol Intoxication | Driving Under the InfluenceUnited States
-
University of ZurichCompletedGastroesophageal Reflux Disease | Healthy VolunteersSwitzerland
-
West German Center of Diabetes and HealthNot yet recruitingOverweight and Obese VolunteersGermany
-
Massachusetts General HospitalNot yet recruitingAlcohol Use Disorder | Liver Cirrhosis, Alcoholic | Alcohol-associated Liver Disease | Alcohol-Associated Hepatitis
-
Mebo Research, Inc.Aurametrix; Menssana Research, Inc.CompletedNutritional and Metabolic DiseasesUnited States, United Kingdom
-
University of North Texas, Denton, TXThe University of Texas Health Science Center at San AntonioRecruitingContingency Management | Alcohol Abuse | Alcohol Intervention | Transdermal Alcohol Monitoring | Deposit ContractUnited States