Alcohol Use Disorder study: Naltrexone
Official title Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06426303
What this study is testing
What is Naltrexone?
This is an investigational medicine being studied to see if it helps people with Alcohol Use Disorder. It is designed to block certain receptors in the brain that are involved in the reward system.
Also referred to as Revia.
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 study aims to find out how a medication called naltrexone affects alcohol cravings and brain health differently in men and women.
- Who it's for
- The study is looking for men and women who have a diagnosis of alcohol use disorder.
- What's involved
- Participants will take a daily pill for 12 weeks, keep a journal of their usage, and complete brain scans, blood tests, and questionnaires.
- Time commitment
- The study lasts 12 weeks and requires weekly phone calls and medical check-ups every two weeks.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 60. Healthy volunteers may be eligible.
You may be able to join if
- 18-60 years old
- must meet diagnosis for recent alcohol-use disorder (DSM-V)
- must not meet DSM-V criteria for a use disorder other than nicotine
You likely can't join if
- Clinically significant neurological, endocrine, hepatic, or systemic disease that would compromise safe participation or confound outcomes
- Left-handedness
- Axis-1 psychiatric diagnoses other than anxiety, depression or post-traumatic stress disorder
- Recreational or prescriptive use of psychotropic medications
- Recreational or prescriptive use of opioid medications or have a past or current history of abuse or dependence on opioids
- MRI contraindications (e.g. metal in body)
See the full eligibility criteria
- 18-60 years old
- must meet diagnosis for recent alcohol-use disorder (DSM-V)
- must not meet DSM-V criteria for a use disorder other than nicotine
- Clinically significant neurological, endocrine, hepatic, or systemic disease that would compromise safe participation or confound outcomes
- Left-handedness
- Axis-1 psychiatric diagnoses other than anxiety, depression or post-traumatic stress disorder
- Recreational or prescriptive use of psychotropic medications
- Recreational or prescriptive use of opioid medications or have a past or current history of abuse or dependence on opioids
- MRI contraindications (e.g. metal in body)
- Positive urine drug screen, except for nicotine and marijuana, on test days
- Women who are pregnant or breastfeeding
- Participants on hormonal therapy or treatments other than pregnancy contraceptives
- Autoimmune or neurodegenerative diseases that present with neuroinflammation (multiple sclerosis, amyotrophic lateral sclerosis, Alzheimer's, Parkinson's)
- Current participation in an investigational drug study
- Alcohol group: \ 3 weeks of abstinence from alcohol
- Alcohol group: Liver disease requiring medication or medical treatment, and/or aspartate or alanine aminotransferase levels greater than 3 times the upper limit of normal, gastrointestinal or renal disease that would...
- Non-english speaker
The study team makes the final eligibility decision.
Where it is enrolling
- Portland, Oregon, 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, but 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 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.