Alcohol AbuseSKNCT02499913
Contingency Management to Reduce Alcohol Use in a Soup Kitchen Sample
A study testing breath alcohol monitoring and contingency management in people with Alcohol Abuse and Contingency Management, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Contingency Management
- What is being tested?
- breath alcohol monitoring and contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alcohol Abuse, Contingency Management
- Being tested
- breath alcohol monitoring, contingency management
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breath alcohol monitoringBehavioural
Daily breath alcohol monitoring
contingency managementBehavioural
Participants can earn chance to win prizes for negative breath alcohol samples.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: breath alcohol monitoring; Behavioral: contingency management |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of contingency management relative to monitoring only
longest duration of abstinence
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Carla Rash, UConn Health
- Investigators
- Carla Rash, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499913
- Sponsor's protocol ID
- 15-177-1
- Other IDs
- P60AA003510
- Acronym
- SK
- Status last verified
- Jun 2017
- First submitted
- 14 Jul 2015
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management to Reduce Alcohol Use in a Soup Kitchen Sample
- ClinicalTrials.gov ID
- NCT02499913
- Acronym / sponsor ID
- SK / 15-177-1
- Conditions
- Alcohol Abuse, Contingency Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jul 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breath alcohol monitoring | Active comparator | Behavioral: breath alcohol monitoringBreath 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. |
| breath monitoring plus prize contingency management | Experimental | Behavioral: breath alcohol monitoring, Behavioral: contingency managementBreath 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breath alcohol monitoringDaily breath alcohol monitoring | Behavioural | breath alcohol monitoring, breath monitoring plus prize contingency management |
| contingency managementParticipants can earn chance to win prizes for negative breath alcohol samples. | Behavioural | breath monitoring plus prize contingency management |
Primary outcome
efficacy of contingency management relative to monitoring only
Time frame: week 4
longest duration of abstinence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Rash, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breath alcohol monitoring and contingency management in people with Alcohol Abuse and Contingency Management, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of contingency management relative to monitoring only (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.