Alcohol AbusePhase 2NCT02588703
Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities
A Phase 2 study testing Cognitive Behavioral Therapy in people with Alcohol Abuse, run by RAND.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- meets criteria for at-risk drinking,
- 21 years+,
- English speaking,
- current client in 3-month DUI program
Who cannot join
- under 21,
- does not speak English,
- does not meet criteria for at-risk drinking
About this study
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.
Read the 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).
- Conditions
- Alcohol Abuse
- Being tested
- Cognitive Behavioral Therapy, Usual Care
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
Coping Skills Treatment
Usual CareBehavioural
Existing DUI program group counseling
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | 9-session 2-hour group cognitive behavioral therapy Receives: Behavioral: Cognitive Behavioral Therapy |
| Usual Care | Active comparator | 9-session 2-hour group counseling Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
heavy drinking (Survey)
frequency of 5 drinks per day for men and 4 drinks per day for women
Measured: 6 months
Secondary outcomes (1)
DUI Behaviors and Attitudes (Survey)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2018
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Osilla, RAND
- Investigators
- Karen C Osilla, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588703
- Sponsor's protocol ID
- R01MD007762
- Status last verified
- Apr 2020
- First submitted
- 17 Aug 2015
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan Osilla K, Watkins KE, Kulesza M, Florez K, Lara-Greenberg M, Miles JN. Study design to evaluate cognitive behavioral therapy among a diverse sample of adults with a first-time DUI offense. Addict Sci Clin Pract. 2016 Mar 31;11(1):7. doi: 10.1186/s13722-016-0053-x.
PubMed 27036221
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Treatment in DUI Programs to Reduce Alcohol-Related Disparities
- ClinicalTrials.gov ID
- NCT02588703
- Acronym / sponsor ID
- R01MD007762
- Conditions
- Alcohol Abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral Therapy9-session 2-hour group cognitive behavioral therapy |
| Usual Care | Active comparator | Behavioral: Usual Care9-session 2-hour group counseling |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- meets criteria for at-risk drinking,
- 21 years+,
- English speaking,
- current client in 3-month DUI program
Key exclusion criteria (3 listed)
- under 21,
- does not speak English,
- does not meet criteria for at-risk drinking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBTCoping Skills Treatment | Behavioural | Cognitive Behavioral Therapy |
| Usual CareExisting DUI program group counseling | Behavioural | Usual Care |
Primary outcome
heavy drinking (Survey)
Time frame: 6 months
frequency of 5 drinks per day for men and 4 drinks per day for women
1 secondary outcome
DUI Behaviors and Attitudes (Survey)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Derived from this study: PubMed 27036221Chan Osilla K, Watkins KE, Kulesza M, Florez K, Lara-Greenberg M, Miles JN. Study design to evaluate cognitive behavioral therapy among a diverse sample of adults with a first-time DUI offense. Addict Sci Clin Pract. 2016 Mar 31;11(1):7. doi: 10.1186/s13722-016-0053-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen C Osilla, PhD principal investigator
RAND
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Behavioral Therapy in people with Alcohol Abuse, run by RAND.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heavy drinking (Survey) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.