NCT03638596

Brief Summary

The current study will evaluate the efficacy of contingency management (i.e., reinforcement for avoiding heavy drinking) among adults arrested for drunk driving and who are at risk for ongoing heavy drinking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

2.9 years

First QC Date

August 16, 2018

Last Update Submit

May 6, 2024

Conditions

Keywords

Alcohol Impaired DrivingDriving While IntoxicatedDriving Under the InfluenceDriving While Impaired

Outcome Measures

Primary Outcomes (1)

  • Percent heavy drinking days

    Percent of days with estimated breath alcohol concentration .08% or higher or self-reported drinks \> 5 for men and \> 4 for women

    8-weeks

Secondary Outcomes (4)

  • Percent drinking days

    8-weeks

  • Follow-up percent heavy drinking days

    12-months

  • Follow-up percent drinking days

    12-months

  • Measurement of alcohol biomarker

    Baseline to 8-weeks

Study Arms (2)

Contingency Management

EXPERIMENTAL

Incentive delivery contingent upon maintaining transdermal alcohol concentration below cut-off

Behavioral: Contingency Management

Control

PLACEBO COMPARATOR

Incentive delivery not contingent on transdermal alcohol concentration

Behavioral: Control

Interventions

Incentive provided for changing alcohol drinking patterns based on ankle monitor

Contingency Management
ControlBEHAVIORAL

Incentive provided is not contingent on alcohol drinking patterns based on ankle monitor

Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • arrested for drunk driving offense

You may not qualify if:

  • significant alcohol withdrawal symptoms
  • medical condition that would contraindicate participation (e.g., pregnancy, scheduled surgery)
  • inability to comprehend the informed consent process or study instructions
  • presence of a DSM-5 psychiatric disorder with symptoms of psychosis and/or delirium
  • incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Driving Under the Influence

Condition Hierarchy (Ancestors)

Criminal BehaviorBehaviorDangerous Behavior

Study Officials

  • Nathalie Hill-Kapturczak, PhD

    The University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: random assignment to treatment and control arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 20, 2018

Study Start

May 1, 2017

Primary Completion

March 15, 2020

Study Completion

March 15, 2021

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations