Alcohol Use DisorderNCT02135237
Contingency Management for Alcohol Use Disorders
A study testing Prize Contingency Management for Alcohol Abstinence in people with Alcohol Use Disorder and Contingency Management, run by UConn Health at 3 sites in United States.
Trial summary
Contingency management (CM) treatments are highly efficacious in improving outcomes of substance abusing patients. However, CM has rarely been applied to individuals with alcohol use disorders, primarily because of technological limitations in monitoring drinking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Contingency Management
- What is being tested?
- Prize Contingency Management for Alcohol Abstinence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2014to Jun 2019
- 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 years or older
- current diagnosis of alcohol use disorder and self report of recent alcohol use
- pass an informed consent quiz
- agree to wear a SCRAMx monitor for 12 weeks
- have a standard SCRAMx compatible phone line in their home or agree to attend the clinic weekly for brief research visits/downloads
- agree to sign an off-campus property transfer form and return SCRAMx equipment
Who cannot join
- serious, uncontrolled psychiatric illness
- in recovery from pathological gambling
- have an unstable address
- intend to participate in activities incompatible with SCRAMx over the next 3 months
- are wearing SCRAMx for legal purposes
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Hospital of Central Connecticut at New Britain General
New Britain, Connecticut, 06050
Farrell Treatment Center
New Britain, Connecticut, 06051
Behavioral Health Network, Inc.
Springfield, Massachusetts, 01104
About this study
Contingency management (CM) treatments are highly efficacious in improving outcomes of substance abusing patients. However, CM has rarely been applied to individuals with alcohol use disorders, primarily because of technological limitations in monitoring drinking. The Secure Continuous Remote Alcohol Monitor (SCRAMx®) is a new technology designed to continuously monitor alcohol consumption 24 hours a day for 7 days per week. The purpose of this study is to evaluate the efficacy of CM in reducing alcohol use using SCRAMx. In total, 120 alcohol abusing or dependent patients initiating outpatient treatment at community-based clinics will be randomly assigned to one of two conditions: standard care, or standard care plus CM with reinforcement based on results of SCRAMx readings. Compared with standard care, it is expected that CM will result in fewer drinking days and longer durations of continuous non-drinking days.
- Conditions
- Alcohol Use Disorder, Contingency Management
- Being tested
- Prize Contingency Management for Alcohol Abstinence, Standard Care
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prize Contingency Management for Alcohol AbstinenceBehavioural
The systematic reinforcement of desired behaviors and the withholding of reinforcement for undesired behaviors
Standard CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standard Care Receives: Behavioral: Standard Care |
| Experimental Group | Experimental | Standard Care plus Prize Contingency Management for Alcohol Abstinence Receives: Behavioral: Prize Contingency Management for Alcohol Abstinence; Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
longest duration of abstinence from alcohol
objective report of alcohol use as measured by SCRAMx device
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- 120 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, Sheila Alessi, UConn Health
- Investigators
- Sheila Alessi, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135237
- Sponsor's protocol ID
- 12-204H-2
- Other IDs
- R01AA021446
- Status last verified
- Oct 2019
- First submitted
- 24 Feb 2014
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management for Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT02135237
- Acronym / sponsor ID
- 12-204H-2
- Conditions
- Alcohol Use Disorder, Contingency Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 9 May 2014 (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.
Contingency management (CM) treatments are highly efficacious in improving outcomes of substance abusing patients. However, CM has rarely been applied to individuals with alcohol use disorders, primarily because of technological limitations in monitoring drinking. The Secure Continuous Remote Alcohol Monitor (SCRAMx®) is a new technology designed to continuously monitor alcohol consumption 24 hours a day for 7 days per week. The purpose of this study is to evaluate the efficacy of CM in reducing alcohol use using SCRAMx. In total, 120 alcohol abusing or dependent patients initiating outpatient treatment at community-based clinics will be randomly assigned to one of two conditions: standard care, or standard care plus CM with reinforcement based on results of SCRAMx readings. Compared with standard care, it is expected that CM will result in fewer drinking days and longer durations of continuous non-drinking days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Standard CareStandard Care |
| Experimental Group | Experimental | Behavioral: Prize Contingency Management for Alcohol Abstinence, Behavioral: Standard CareStandard Care plus Prize Contingency Management for Alcohol Abstinence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 years or older
- current diagnosis of alcohol use disorder and self report of recent alcohol use
- pass an informed consent quiz
- agree to wear a SCRAMx monitor for 12 weeks
- have a standard SCRAMx compatible phone line in their home or agree to attend the clinic weekly for brief research visits/downloads
Key exclusion criteria (5 listed)
- serious, uncontrolled psychiatric illness
- in recovery from pathological gambling
- have an unstable address
- intend to participate in activities incompatible with SCRAMx over the next 3 months
- are wearing SCRAMx for legal purposes
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 |
|---|---|---|
| Prize Contingency Management for Alcohol AbstinenceThe systematic reinforcement of desired behaviors and the withholding of reinforcement for undesired behaviors | Behavioural | Experimental Group |
| Standard Care | Behavioural | Control Group, Experimental Group |
Primary outcome
longest duration of abstinence from alcohol
Time frame: three months
objective report of alcohol use as measured by SCRAMx device
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 1 Nov 2019.
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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.
Sheila Alessi, Ph.D. principal investigator
UConn Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prize Contingency Management for Alcohol Abstinence in people with Alcohol Use Disorder and Contingency Management, run by UConn Health at 3 sites 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 6 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
longest duration of abstinence from alcohol (time frame: three months). 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 1 Nov 2019.