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Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities

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. Read our disclaimer for details. Identifier: NCT02588703
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : April 10, 2020
Information provided by (Responsible Party):
Karen Osilla, RAND

Brief Summary:
The current study evaluates the efficacy of Cognitive Behavioral Therapy (CBT) in DUI programs for individuals with a first-time offense. Investigators will utilize a two-group randomized design where individuals enrolled in a DUI program with a first-time conviction will be randomized to Cognitive Behavioral Therapy (CBT; n=150) or Usual Care (UC; n=150). Participants will be assessed at baseline, immediately post-treatment, and 6-months post-treatment. Recidivism data will also be collected using administrative data two years post-treatment.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Behavioral: Cognitive Behavioral Therapy Behavioral: Usual Care Phase 2

Detailed Description:
Enormous unmet needs for alcohol treatment exist among individuals convicted of driving under the influence (DUI) since up to 43% recidivate and 67% meet criteria for alcohol dependence. Investigators will test whether delivering a cognitive behavioral treatment (CBT) for alcohol use disorders (AUDs) as part of a mandated DUI program improves health outcomes, and reduces alcohol use, alcohol-related problems and injuries, and DUI recidivism compared to usual care. The study has the potential to promote the public welfare by providing treatment to individuals with a DUI conviction, while focusing on Latinos, who are disproportionately less likely to access treatment and more likely to be arrested for a DUI, to have higher rates of recidivism, and to die in alcohol-related crashes than their white counterparts. The study is innovative because it would be the first to address effectiveness of treatment for AUDs embedded within a DUI program. Investigators will conduct a randomized trial of a 9-session group-based CBT (n=150) as compared to group-based usual care (UC; n=150) immediately after and 6 months after the end of treatment. Short-term outcomes include alcohol use (rates of heavy drinking, percent days abstinent), alcohol use-related self-efficacy, and intent to drink and drive. Investigators will also examine whether race/ethnicity, gender, acculturation, and alcohol situational norms predict our primary treatment outcomes (rates of heavy drinking, percent days abstinent) and DUI recidivism (alcohol-related violations).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities
Actual Study Start Date : October 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
9-session 2-hour group cognitive behavioral therapy
Behavioral: Cognitive Behavioral Therapy
Coping Skills Treatment
Other Name: CBT

Active Comparator: Usual Care
9-session 2-hour group counseling
Behavioral: Usual Care
Existing DUI program group counseling

Primary Outcome Measures :
  1. heavy drinking (Survey) [ Time Frame: 6 months ]
    frequency of 5 drinks per day for men and 4 drinks per day for women

Secondary Outcome Measures :
  1. DUI Behaviors and Attitudes (Survey) [ Time Frame: 6 months ]

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

Inclusion Criteria:

  • meets criteria for at-risk drinking,
  • 21 years+,
  • English speaking,
  • current client in 3-month DUI program

Exclusion Criteria:

  • under 21,
  • does not speak English,
  • does not meet criteria for at-risk drinking

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 identifier (NCT number): NCT02588703

Sponsors and Collaborators
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Principal Investigator: Karen C Osilla, PhD RAND
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Karen Osilla, Senior Behavioral Scientist, RAND Identifier: NCT02588703    
Other Study ID Numbers: R01MD007762 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders