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Behavioral Intervention
Brief Intervention for Opioid Use Disorder with Alcohol Consumption (COAPS Trial)
N/A
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months. changes in alcohol use will be assessed by comparing baseline to month 2. changes in alcohol use will also be assessed by comparing month 2 to month 3.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to develop an intervention to reduce co-use of opioids & alcohol & test its effectiveness. Results will inform a larger trial.
Who is the study for?
This trial is for English-speaking adults over 18 who currently use alcohol and are prescribed opioids, but not for cancer treatment. They must have a reliable phone and stay in the area for the next 3 months. It's not for those using only buprenorphine, pregnant individuals, anyone planning to leave the area soon, or those with recent psychotic/manic episodes.
What is being tested?
The study is testing an intervention adapted from one designed to address opioid misuse. Participants will receive either Alcohol-targeted Brief Intervention-Medication Therapy Management or standard medication counseling to prevent co-use of opioids and alcohol.
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medications, traditional side effects like you'd see with drugs aren't expected. However, participants may experience discomfort discussing personal substance use habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months. changes in alcohol use will be assessed by comparing baseline to month 2. changes in alcohol use will also be assessed by comparing month 2 to month 3.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months. changes in alcohol use will be assessed by comparing baseline to month 2. changes in alcohol use will also be assessed by comparing month 2 to month 3.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alcohol use reductions
Non opioid medication alternative
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Alcohol-targeted Brief Intervention-Medication Therapy ManagementExperimental Treatment1 Intervention
Alcohol-targeted Brief Intervention-Medication Therapy Management (ABI-MTM) intervention is a pharmacy-based medication management intervention, combined with Screening, Brief Intervention, and Referral to Treatment
Group II: Standard medication counselingActive Control1 Intervention
Standard Medication Counseling (SMC) (1) will offer counseling, (2) document counseling was offered, (3) offer a counseling process for patients not present, and (4) discuss generic substitution. Following this session, in the second SMC component, participants will be emailed/mailed (according to participant preference) safety information about co-use of alcohol and opioids
Find a Location
Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
839 Previous Clinical Trials
1,083,731 Total Patients Enrolled
University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,040 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking prescribed opioid medication.I am 18 years old or older.I do not have a phone for study staff to contact me.I am not currently undergoing any cancer treatment.I have had a psychotic or manic episode in the past month.
Research Study Groups:
This trial has the following groups:- Group 1: Alcohol-targeted Brief Intervention-Medication Therapy Management
- Group 2: Standard medication counseling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.