Encouraging Abstinence Behavior in an Opioid Epidemic: A Pilot Study

Last registered on September 09, 2020

Pre-Trial

Trial Information

General Information

Title
Encouraging Abstinence Behavior in an Opioid Epidemic: A Pilot Study
RCT ID
AEARCTR-0005000
Initial registration date
November 06, 2019

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
November 08, 2019, 10:16 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
September 09, 2020, 3:30 PM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

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Primary Investigator

Affiliation
UC Santa Cruz

Other Primary Investigator(s)

PI Affiliation
Advocate Aurora Health
PI Affiliation
University of Chicago

Additional Trial Information

Status
On going
Start date
2020-08-15
End date
2022-12-31
Secondary IDs
Abstract
Numerous studies have shown that providing incentives can encourage abstinence from drugs in drug-treatment settings. Despite evidence that incentives are effective and the increasing need for effective approaches to combat the addiction crisis, incentive programs have not been widely implemented. A key barrier is that while the benefits are largely borne by patients and taxpayers, there are large logistical costs that must be borne by clinics. We propose to conduct the first randomized evaluation of an innovative, scalable incentives program for opioid addiction delivered through a mobile application. The efficacy of this approach has not been tested rigorously before.
External Link(s)

Registration Citation

Citation
Dizon-Ross, Rebecca, Mindy Waite and Ariel Zucker. 2020. "Encouraging Abstinence Behavior in an Opioid Epidemic: A Pilot Study." AEA RCT Registry. September 09. https://doi.org/10.1257/rct.5000
Sponsors & Partners

Sponsors

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Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2020-08-15
Intervention End Date
2022-12-31

Primary Outcomes

Primary Outcomes (end points)
Duration of abstinence as measured by in-clinic urinalysis, percentage of urine drug tests negative, enrollment rates
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
To answer our research questions, we will conduct a randomized controlled trial of temporary incentives to encourage either abstinence, or inputs to abstinence, among 600 adults with opioid use disorders in Milwaukee, Wisconsin. Participants will be recruited from outpatients with substance use disorders in treatment at the Adult Behavioral Health Program within the Aurora Health Care System. Incentivized behaviors will be monitored and rewarded through a mobile application developed by our implementing technology partner, Dynamicare Management. We will evaluate the incentives using a combination of administrative data and surveys. In preparation for this experiment, we will conduct a Phase 1 pilot of 30 individuals to test and fine-tune our study protocols. The full experimental design will be developed following this pilot.
Experimental Design Details
Not available
Randomization Method
Ordered treatment assignment lists are randomly generated in the office by a computer using Stata 15, and treatments are assigned to participants on rolling basis.
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
1 clinic
Sample size: planned number of observations
We aim to enroll approximately 30 individuals in the pilot.
Sample size (or number of clusters) by treatment arms
The following treatment group distribution in the pilot is approximate, since enrollees will be assigned to treatments in a pre-determined order but may withdraw.

Treatment Groups:
T1 – Inputs: 1/3
T2 – Outcomes: 1/3
T3 – Combined: 1/3
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Part of the aim of this pilot is to determine MDEs for the main experiment.
IRB

Institutional Review Boards (IRBs)

IRB Name
Aurora IRB
IRB Approval Date
2020-04-30
IRB Approval Number
19-127E
Analysis Plan

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