Alcohol Use DisorderNCT03701204
Contingency Management for Alcohol Use Disorder
A study testing DynamiCare Rewards in people with Alcohol Use Disorder, run by DynamiCare Health at 2 sites in United States.
Trial summary
Randomized pilot study of a device (smartphone app) that poses non-significant risk to participants and is exempt from Investigational Device Exemption regulations [21 Code of Federal Regulations 812.2(c) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- DynamiCare Rewards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2018to 21 Aug 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
- Participants in the pilot study will be 60 new intakes to Gosnold's outpatient Substance Use Disorder (SUD) program who:
- are >18 years old;
- meet DSM-5 criteria for current (past year) alcohol use disorder, at least moderate severity;
- identify alcohol as the primary drug problem;
- Currently use alcohol (past 7 days) or have been in treatment 14 days or less and used alcohol within 7 days of treatment entry;
- have and use an Android or iOS smartphone with acceptable
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- capability;
- are willing to participate in home testing and use of the smartphone,
- speak and read the English language adequately to understand smartphone commands and responses and
- are willing to be randomly assigned to receive treatment with or without the smartphone app as an added feature.
Who cannot join
- Participants must not currently be suicidal or actively psychotic, by clinician judgement.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gosnold on Cape Cod
Centerville, Massachusetts, 02632
Gosnold
Falmouth, Massachusetts, 02540
About this study
Official title: Integrating Contingency Management Into Routine Care for Alcohol Use Disorder
Randomized pilot study of a device (smartphone app) that poses non-significant risk to participants and is exempt from Investigational Device Exemption regulations [21 Code of Federal Regulations 812.2(c)
Read the detailed description
To test the feasibility/acceptability and efficacy of a minimum viable product (MVP) of a smartphone app for patients with alcohol use disorder who are in active treatment and recovery to perform self-tracking of their recovery behavior (e.g., abstinence) and focus on their motivation to maintain their desired health behaviors (i.e., abstinence).
- Conditions
- Alcohol Use Disorder
- Being tested
- DynamiCare Rewards
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynamiCare RewardsBehavioural
Participants assigned to the DynamiCare Rewards group will receive the following:
- App on their smartphone
- Substance Testing Devices: BACTrack Mobile Pro - submits BAC results directly to smartphone via Bluetooth and Saliva Test Kits.
- Next Step debit card to receive financial incentives
- Participant will be prompted via the app to conduct breathalyzer/saliva tests, using the devices camera to take "selfie" photo/videos to prevent cheating.
- Negative tests result in participant receiving electronic virtual "coins", which can be transferred from reserve account (reserve account inaccessible to participant) to the spendable Next Step debit card.
- The amount of coins and funds are available on a progressive variable reward schedule.
| Study group | Role | What they receive |
|---|---|---|
| DynamiCare Rewards | Experimental | The study will test the feasibility/acceptability and efficacy of DynamiCare Rewards™. DynamiCare Rewards is an iOS/Android app which automates Contingency Management (CM) to help the patient self-monitor and focus attention on his/her behavioral goals (i.e., abstinence) for alcohol or other substance use disorders. Receives: Behavioral: DynamiCare Rewards |
| Control | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants abstinent from alcohol at each monthly assessment time point (negative urine test and self-report of no use in past 30 days)
The pilot efficacy study will utilize alcohol abstinence at each assessment time point as the primary outcome. This is defined as a negative ethyl glucuronide urine test (witnessed) at the monthly assessment time points and self-report of no alcohol use in the past 30 days.
Measured: 12-week intervention period
Secondary outcomes (3)
Percent of participants abstinent from all drugs at each monthly assessment time point (negative urine test and self-report of no use in past 30 days)
Groups will be compared using Generalized Estimating Equation (GEE) analysis on the percent of participants abstinent over time at each time point.
Measured: 12-week intervention period
Longest continuous period of abstinence from alcohol and from drugs and alcohol
Groups will be compared using GEE analysis on the percent of participants abstinent over time at each time point.
Measured: 12-week intervention period
Retention in treatment
Groups will be compared on the number of days retained in treatment according to the site's Electronic Health Record data, and also on the graduation rate from treatment vs. leaving against medical advice.
Measured: 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start8 Oct 2018
- Primary completion21 Aug 2019
- Study completion21 Aug 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- DynamiCare Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Eric Gastfriend, DynamiCare Health
- Investigators
- Eric Gastfriend, MBA, Principal investigator, DynamiCare Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701204
- Sponsor's protocol ID
- DCH001
- Status last verified
- Aug 2020
- First submitted
- 7 Oct 2018
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We intend to make participant data available by request as long as it is unidentifiable.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Contingency Management Into Routine Care for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03701204
- Acronym / sponsor ID
- DCH001
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- DynamiCare HealthIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 9 Oct 2018 (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.
Randomized pilot study of a device (smartphone app) that poses non-significant risk to participants and is exempt from Investigational Device Exemption regulations [21 Code of Federal Regulations 812.2(c)
Detailed description
To test the feasibility/acceptability and efficacy of a minimum viable product (MVP) of a smartphone app for patients with alcohol use disorder who are in active treatment and recovery to perform self-tracking of their recovery behavior (e.g., abstinence) and focus on their motivation to maintain their desired health behaviors (i.e., abstinence).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DynamiCare Rewards | Experimental | Behavioral: DynamiCare RewardsThe study will test the feasibility/acceptability and efficacy of DynamiCare Rewards™. DynamiCare Rewards is an iOS/Android app which automates Contingency Management (CM) to help the patient self-monitor and focus attention on his/her behavioral goals (i.e., abstinence) for alcohol or other substance use disorders. |
| Control | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants in the pilot study will be 60 new intakes to Gosnold's outpatient Substance Use Disorder (SUD) program who:
- are >18 years old;
- meet DSM-5 criteria for current (past year) alcohol use disorder, at least moderate severity;
- identify alcohol as the primary drug problem;
- Currently use alcohol (past 7 days) or have been in treatment 14 days or less and used alcohol within 7 days of treatment entry;
Key exclusion criteria (1 listed)
- Participants must not currently be suicidal or actively psychotic, by clinician judgement.
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 |
|---|---|---|
| DynamiCare RewardsParticipants assigned to the DynamiCare Rewards group will receive the following: 1. App on their smartphone 2. Substance Testing Devices: BACTrack Mobile Pro - submits BAC results directly to smartphone via Bluetooth and Saliva Test Kits. 3. Next Step debit card to receive financial incentives 4. Participant will be prompted via the app to conduct breathalyzer/saliva tests, using the devices camera to take "selfie" photo/videos to prevent cheating. 5. Negative tests result in participant receiving electronic virtual "coins", which can be transferred from reserve account (reserve account inaccessible to participant) to the spendable Next Step debit card. 6. The amount of coins and funds are available on a progressive variable reward schedule. | Behavioural | DynamiCare Rewards |
Primary outcome
Percent of participants abstinent from alcohol at each monthly assessment time point (negative urine test and self-report of no use in past 30 days)
Time frame: 12-week intervention period
The pilot efficacy study will utilize alcohol abstinence at each assessment time point as the primary outcome. This is defined as a negative ethyl glucuronide urine test (witnessed) at the monthly assessment time points and self-report of no alcohol use in the past 30 days.
3 secondary outcomes
Percent of participants abstinent from all drugs at each monthly assessment time point (negative urine test and self-report of no use in past 30 days)
Time frame: 12-week intervention period
Longest continuous period of abstinence from alcohol and from drugs and alcohol
Time frame: 12-week intervention period
Retention in treatment
Time frame: 12-week intervention period
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 11 Aug 2020.
- Individual participant dataSharing planned: Undecided. We intend to make participant data available by request as long as it is unidentifiable.
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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.
Eric Gastfriend, MBA principal investigator
DynamiCare Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DynamiCare Rewards in people with Alcohol Use Disorder, run by DynamiCare Health at 2 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 10 inclusion and 1 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 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Percent of participants abstinent from alcohol at each monthly assessment time point (negative urine test and self-report of no use in past 30 days) (time frame: 12-week intervention period). 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 11 Aug 2020.