Alcohol Use DisorderNCT04182022
Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
A study testing Contingency management: Contingent incentives and Contingency management: Noncontingent incentives in people with Alcohol Use Disorder, run by Virginia Polytechnic Institute and State University.
Trial summary
Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Contingency management: Contingent incentives and Contingency management: Noncontingent incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 10 Jul 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Provide written informed consent
- Meet Diagnostic and Statistical Manual criteria for alcohol use disorder
- Express a desire to cut down or quit drinking
- Be willing to pay a $75 deposit toward their incentive fund
Who cannot join
- Pregnant or lactating
- Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine)
- Score 23 or greater on the Alcohol Withdrawal Symptom Checklist
- Have immediate plans to move out of the area
About this study
Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this feasibility study is to use a breathalyzer and cost-controlling deposit contracts to facilitate a contingency-management intervention to reduce alcohol use that requires no in-person contact between the participants and the study staff during the intervention phase.
- Conditions
- Alcohol Use Disorder
- Being tested
- Contingency management: Contingent incentives, Contingency management: Noncontingent incentives
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency management: Contingent incentivesBehavioural
Monetary incentives are delivered to participants contingent upon on- time breathalyzer submissions and verified abstinence from alcohol.
Contingency management: Noncontingent incentivesBehavioural
Monetary incentives are delivered to participants contingent upon on- time breathalyzer submissions only with no contingency on alcohol use.
| Study group | Role | What they receive |
|---|---|---|
| Contingent | Active comparator | The Contingent group will receive nearly immediate monetary payments over the internet each day they remotely provide negative breathalyzer samples, but will not receive the payments if they provide positive samples or fail to provide samples in a timely manner. Receives: Behavioral: Contingency management: Contingent incentives |
| Noncontingent | Sham comparator | The Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples. Receives: Behavioral: Contingency management: Noncontingent incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent days abstinent from alcohol during intervention
Three breathalyzer assessments will be collected per day during the treatment period. This outcome measure will consist of the percent days when all three breathalyzers were on time and negative for alcohol.
Measured: Percent days abstinent is the aggregate measure throughout the 21-day intervention period
Treatment acceptability
Participant ratings of treatment acceptability will be collected during assessment sessions
Measured: Baseline, one day after treatment end, and at a one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 Dec 2016
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182022
- Sponsor's protocol ID
- R21AA023605
- Status last verified
- Jun 2023
- First submitted
- 26 Nov 2019
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final research data for this project will be made as available as possible, while safeguarding the privacy of participants and protecting all confidential and proprietary data. Data will be available for use after the main findings from the final dataset have been accepted for publication. The data and associated documentation will only be made available to users under a Data Use Agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant and 2) a commitment to destroying or returning the data after analyses are completed. To ensure compliance with HIPAA regulations, only a Limited Data Set will be available for use. The method of data release will be determined on a case-by-case basis depending upon the amount and type of data required.
Publications
Koffarnus MN, Kablinger AS, Kaplan BA, Crill EM. Remotely administered incentive-based treatment for alcohol use disorder with participant-funded incentives is effective but less accessible to low-income participants. Exp Clin Psychopharmacol. 2021 Oct;29(5):555-565. doi: 10.1037/pha0000503. Epub 2021 Jun 10.
PubMed 34110885
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financially Sustainable Remote Treatment for Alcohol Abuse: Feasibility
- ClinicalTrials.gov ID
- NCT04182022
- Acronym / sponsor ID
- R21AA023605
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 2 Dec 2019 (actual)
- 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.
Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this feasibility study is to use a breathalyzer and cost-controlling deposit contracts to facilitate a contingency-management intervention to reduce alcohol use that requires no in-person contact between the participants and the study staff during the intervention phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingent | Active comparator | Behavioral: Contingency management: Contingent incentivesThe Contingent group will receive nearly immediate monetary payments over the internet each day they remotely provide negative breathalyzer samples, but will not receive the payments if they provide positive samples or fail to provide samples in a timely manner. |
| Noncontingent | Sham comparator | Behavioral: Contingency management: Noncontingent incentivesThe Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Provide written informed consent
- Meet Diagnostic and Statistical Manual criteria for alcohol use disorder
- Express a desire to cut down or quit drinking
- Be willing to pay a $75 deposit toward their incentive fund
Key exclusion criteria (4 listed)
- Pregnant or lactating
- Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine)
- Score 23 or greater on the Alcohol Withdrawal Symptom Checklist
- Have immediate plans to move out of the area
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 |
|---|---|---|
| Contingency management: Contingent incentivesMonetary incentives are delivered to participants contingent upon on- time breathalyzer submissions and verified abstinence from alcohol. | Behavioural | Contingent |
| Contingency management: Noncontingent incentivesMonetary incentives are delivered to participants contingent upon on- time breathalyzer submissions only with no contingency on alcohol use. | Behavioural | Noncontingent |
Primary outcome
Percent days abstinent from alcohol during intervention
Time frame: Percent days abstinent is the aggregate measure throughout the 21-day intervention period
Three breathalyzer assessments will be collected per day during the treatment period. This outcome measure will consist of the percent days when all three breathalyzers were on time and negative for alcohol.
Treatment acceptability
Time frame: Baseline, one day after treatment end, and at a one-month follow-up
Participant ratings of treatment acceptability will be collected during assessment sessions
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 7 Jun 2023.
- Derived from this study: PubMed 34110885Koffarnus MN, Kablinger AS, Kaplan BA, Crill EM. Remotely administered incentive-based treatment for alcohol use disorder with participant-funded incentives is effective but less accessible to low-income participants. Exp Clin Psychopharmacol. 2021 Oct;29(5):555-565. doi: 10.1037/pha0000503. Epub 2021 Jun 10.
- Individual participant dataSharing planned: Yes. Final research data for this project will be made as available as possible, while safeguarding the privacy of participants and protecting all confidential and proprietary data. Data will be available for use after the main findings from the final dataset have been accepted for publication. The data and associated documentation will only be made available to users under a Data Use Agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant and 2) a commitment to destroying or returning the data after analyses are completed. To ensure compliance with HIPAA regulations, only a Limited Data Set will be available for use. The method of data release will be determined on a case-by-case basis depending upon the amount and type of data required.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management: Contingent incentives and Contingency management: Noncontingent incentives in people with Alcohol Use Disorder, run by Virginia Polytechnic Institute and State University.
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 5 inclusion and 4 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 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Percent days abstinent from alcohol during intervention (time frame: Percent days abstinent is the aggregate measure throughout the 21-day intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04182022, which also lists 1 linked publication.
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 7 Jun 2023.