Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02588703
Other study ID # R01MD007762
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2015
Est. completion date April 2020

Study information

Verified date April 2020
Source RAND
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 351
Est. completion date April 2020
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive Behavioral Therapy
Coping Skills Treatment
Usual Care
Existing DUI program group counseling

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
RAND

Outcome

Type Measure Description Time frame Safety issue
Primary heavy drinking (Survey) frequency of 5 drinks per day for men and 4 drinks per day for women 6 months
Secondary DUI Behaviors and Attitudes (Survey) 6 months
See also
  Status Clinical Trial Phase
Completed NCT03165942 - Neuroendocrine Response to Oral Alcohol Administration Phase 1
Recruiting NCT05343039 - Technology Enhanced Adolescent Mental Health (TEAM) N/A
Active, not recruiting NCT04070521 - EEG Monitoring in the Emergency Department
Completed NCT03169244 - Buproprion for Binge Drinking Phase 2
Recruiting NCT05246202 - Personalized Feedback Intervention for Latinx Drinkers With Anxiety N/A
Completed NCT05036499 - PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain N/A
Recruiting NCT04368416 - Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
Not yet recruiting NCT04557631 - Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
Terminated NCT00890149 - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults Phase 2
Completed NCT02179749 - Mifepristone Treatment of Alcohol Use Disorder Phase 2
Completed NCT02681406 - Smartphone Based Continuing Care for Alcohol N/A
Completed NCT02448134 - A Community-Based Strategy for Preventing Underage Drinking N/A
Withdrawn NCT01847300 - cSBI-M for Young Military Personnel N/A
Withdrawn NCT01796158 - Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Withdrawn NCT01511679 - Brain-imaging and Adolescent Neuroscience Consortium N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Withdrawn NCT01275391 - cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use Phase 1/Phase 2
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Completed NCT01207258 - Brief Intervention for Problem Drinking and Partner Violence Phase 2