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Contingency Management for Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03701204
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Eric Gastfriend, DynamiCare Health

Brief 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)

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Behavioral: DynamiCare Rewards Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Integrating Contingency Management Into Routine Care for Alcohol Use Disorder
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: DynamiCare Rewards
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.
Behavioral: DynamiCare Rewards

Participants 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.

No Intervention: Control
Treatment as usual



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    Groups will be compared using Generalized Estimating Equation (GEE) analysis on the percent of participants abstinent over time at each time point.

  2. Longest continuous period of abstinence from alcohol and from drugs and alcohol [ Time Frame: 12-week intervention period ]
    Groups will be compared using GEE analysis on the percent of participants abstinent over time at each time point.

  3. Retention in treatment [ Time Frame: 12-week intervention period ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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
  • 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.

Exclusion Criteria:

• Participants must not currently be suicidal or actively psychotic, by clinician judgement.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701204


Contacts
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Contact: Daniel Cato 5083313697 dcato@gosnold.org
Contact: Eric Gastfriend, MBA egastfriend@dynamicarehealth.com

Locations
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United States, Massachusetts
Gosnold on Cape Cod Recruiting
Centerville, Massachusetts, United States, 02632
Contact: Daniel Cato    508-331-3697    dcato@gosnold.org   
Gosnold Recruiting
Falmouth, Massachusetts, United States, 02540
Contact: Daniel Cato    508-331-3697    dcato@gosnold.org   
Sponsors and Collaborators
DynamiCare Health
Johns Hopkins University
Investigators
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Principal Investigator: Eric Gastfriend, MBA DynamiCare Health

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Responsible Party: Eric Gastfriend, Principal Investigator, DynamiCare Health
ClinicalTrials.gov Identifier: NCT03701204    
Other Study ID Numbers: DCH001
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We intend to make participant data available by request as long as it is unidentifiable.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs