BridgeMD
New treatment option for Alcohol Use Disorder
Official title Alcohol Use Disorder and Cannabidiol
ClinicalTrials.gov ID: NCT05613608
What this study is testing
What is Cannabidiol?
Cannabidiol is an investigational medicine, being studied as a potential treatment for alcohol use disorder.
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
- This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Must be ≥21 years old.
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate...
- Expresses desire to reduce or quit drinking.
- If male, reports drinking, on average, at least 15 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at...
- Able to attend in-person visits at the study site.
You likely can't join if
- Self-reported DSM-V diagnosis of any other substance use disorder.
- Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.
- Uses CBD products for medical reasons.
- Self-reports or indicates having a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress...
- Endorsing item 2 on the C-SSRS measure of suicide risk.
- Currently taking any of the following medications:
See the full eligibility criteria
- Must be ≥21 years old.
- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms).
- Expresses desire to reduce or quit drinking.
- If male, reports drinking, on average, at least 15 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 10 standard drinks per week prior to screening, or if a male...
- Able to attend in-person visits at the study site.
- Participants reporting current nicotine use in any form will be included.
- Self-reported DSM-V diagnosis of any other substance use disorder.
- Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days.
- Uses CBD products for medical reasons.
- Self-reports or indicates having a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, cluster B...
- Endorsing item 2 on the C-SSRS measure of suicide risk.
- Currently taking any of the following medications:
- Those known to have a major interaction with Epidiolex.
- Acute treatment with any antiepileptic medications.
- Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate).
- Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens).
- Clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion.
- Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer.
- Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
- Current charges pending for a violent crime (not including DUI-related offenses).
- Lack of a stable living situation.
- Lack of access to internet.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, 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, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, 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.