BridgeMD
New treatment option for Alcohol Use Disorder
Official title Emergency Department-Initiated Medications for Alcohol Use Disorder
ClinicalTrials.gov ID: NCT05827159
What this study is testing
What is Naltrexone Pill?
Naltrexone Pill is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alcohol use disorder.
Also referred to as Oral naltrexone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The proposed study will be the first randomized clinical trial to evaluate a comprehensive Emergency Department (ED)-based intervention for moderate to severe Alcohol Use Disorder (AUD) combining Screening, Brief Intervention and Referral to Treatment (SBIRT) with ED-initiated medications for treatment of alcohol use disorder (MAUD). The primary objective of this phase 3 study is to evaluate for differences in treatment engagement 30 days after ED visit between emergency department patients with moderate to severe alcohol use disorder (AUD) who are randomized to initiate medications for the treatment for AUD in the ED in addition to receiving a brief intervention and referral to ongoing treatment, which all participants will receive.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Between 18 and 80 years in age
- Diagnosed with moderate to severe Alcohol Use Disorder
- Stated willingness and ability to comply with all study procedures and availability for the duration of the study
- Reproductive aged females will have a negative pregnancy test within the past 24 hours and agree to use of highly effective family planning during...
- Able to speak English sufficiently to understand study procedures and provide written informed consent to participate in the study.
You likely can't join if
- A current diagnosis of OUD, self-reported past 7 day opioid or opioid pain medication use, or a positive urine opioid screen (opiates, methadone...
- Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery)
- History of complicated alcohol withdrawal
- Condition that precludes interview (i.e., life threatening injury/illness)
- Inability to consent due to cognitive impairment
- Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation
See the full eligibility criteria
- Between 18 and 80 years in age
- Diagnosed with moderate to severe Alcohol Use Disorder
- Stated willingness and ability to comply with all study procedures and availability for the duration of the study
- Reproductive aged females will have a negative pregnancy test within the past 24 hours and agree to use of highly effective family planning during study participation period
- Able to speak English sufficiently to understand study procedures and provide written informed consent to participate in the study.
- Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4.
- A current diagnosis of OUD, self-reported past 7 day opioid or opioid pain medication use, or a positive urine opioid screen (opiates, methadone, buprenorphine, oxycodone, hydrocodone, tramadol and fentanyl)
- Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery)
- History of complicated alcohol withdrawal
- Condition that precludes interview (i.e., life threatening injury/illness)
- Inability to consent due to cognitive impairment
- Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation
- In police custody
- Unable to provide contact information
- Previously enrolled in this study or currently enrolled in another study for which they are currently receiving study medications or active ongoing intervention
- Any contraindication to naltrexone or gabapentin, including known allergy, renal failure, acute hepatitis, hepatic failure,1 or severe lung disease or other chronic conditions such as chronic obstructive pulmonary...
- Creatine Clearance \<60 mL/min within past 72 hours.
- Currently pregnant or breast feeding
- Requiring hospitalization at the time of the index visit
- Past week treatment with medications for the treatment of alcohol use disorder
- Taking gabapentin or naltrexone for any reason
- Appearing unable or unwilling to comply with discharge instructions or complete follow-up
- Current residence outside of the state of Connecticut
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, 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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, 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.