Recruiting NA Opioid Use Disorder

New treatment option for Opioid Use Disorder

Official title Brief Digitally-Enhanced Intervention for Reducing Alcohol Use During MOUD

ClinicalTrials.gov ID: NCT06718491

What this study is testing

What it's testing
The goal of this clinical trial is to reduce heavy drinking and enhance medication for opioid use disorder (MOUD) outcomes in individuals receiving MOUD. The main questions it aims to answer are: Does the brief, digitally-enhanced, virtual psychotherapeutic intervention, called Managing Physical Reactions to Overwhelming Emotions (IMPROVE), impact daily alcohol use and MOUD adherence?

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Enrolled in outpatient medication for opioid use disorder (MOUD) program (within the past month)
  • Heavy alcohol user defined using the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria (i.e., consume 8+/15+ drinks per week...
  • Elevated psychological distress defined as a total score of \> 12 on the Kessler Psychological Distress Scale (K10; 0 to 40 range)
  • 18 years of age or older
  • Can read and comprehend English

You likely can't join if

  • Do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent
  • Presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g...
  • Current comorbid moderate to severe substance use disorder other than alcohol and opioids
  • Limited or no access to a smart phone that is compatible with the mobile application
  • Participation in Phase One
  • Possibility of being pregnant (by self-report)
See the full eligibility criteria
Who can join
  • Enrolled in outpatient medication for opioid use disorder (MOUD) program (within the past month)
  • Heavy alcohol user defined using the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria (i.e., consume 8+/15+ drinks per week [women/men] with at least two binge episodes [4/5+ drinks for women/men in a...
  • Elevated psychological distress defined as a total score of \> 12 on the Kessler Psychological Distress Scale (K10; 0 to 40 range)
  • 18 years of age or older
  • Can read and comprehend English
What rules you out
  • Do not pass the informed decision-making capacity screener, suggesting cognitive impairment or an inability to provide informed consent
  • Presence of a psychiatric or medical condition that would prevent them from providing informed consent or participating in the treatments (e.g., psychosis, mania, acute intoxication)
  • Current comorbid moderate to severe substance use disorder other than alcohol and opioids
  • Limited or no access to a smart phone that is compatible with the mobile application
  • Participation in Phase One
  • Possibility of being pregnant (by self-report)
  • Current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer

The study team makes the final eligibility decision.

Where it's taking place

  • Columbus, Ohio, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.