NCT03701204

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

October 8, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2019

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

October 7, 2018

Last Update Submit

August 10, 2020

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (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)

    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.

    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)

    12-week intervention period

  • Longest continuous period of abstinence from alcohol and from drugs and alcohol

    12-week intervention period

  • Retention in treatment

    12-week intervention period

Study Arms (2)

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.

Behavioral: DynamiCare Rewards

Control

NO INTERVENTION

Treatment as usual

Interventions

DynamiCare RewardsBEHAVIORAL

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.

DynamiCare Rewards

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gosnold on Cape Cod

Centerville, Massachusetts, 02632, United States

Location

Gosnold

Falmouth, Massachusetts, 02540, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Eric Gastfriend, MBA

    DynamiCare Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2018

First Posted

October 9, 2018

Study Start

October 8, 2018

Primary Completion

August 21, 2019

Study Completion

August 21, 2019

Last Updated

August 11, 2020

Record last verified: 2020-08

Locations

US(2)