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New treatment option for Alcohol Use Disorder
Official title Naltrexone in AUD Reward Drinkers
ClinicalTrials.gov ID: NCT05028062
What this study is testing
What is XR-NTX 380 mg, intramuscular injection?
XR-NTX 380 mg, intramuscular injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for alcohol use disorder.
Also referred to as Vivitrol naltrexone for extended-release injectable suspension.
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 study is a phase IV, two-arm, randomized, double-blind, placebo-controlled study to assess whether individuals identified as primarily reward drinkers are significantly more likely to reduce heavy drinking if they receive XR-NTX than a matching placebo injection. Study subjects will receive monthly injections of long-acting injectable naltrexone 380 mg (4 mL) or matching placebo.
- Phase 4: studies an already-approved treatment
- 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 18 to 65
You may be able to join if
- Age 18-65 years old
- Willing to provide signed, informed consent and commit to completing the study procedures
- Able to read at an 8th grade or higher level
- Current DSM-5 diagnosis of AUD
- Reports consuming 24+ standard drinks (men) or 18+ standard drinks (women) weekly on average over the month prior to consent
You likely can't join if
- Planned surgery within the timeframe of the study
- A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory...
- Chronic or episodic painful conditions that could require opioid medications for pain control
- History of seizure disorder (excluding childhood febrile seizures)
- History of allergy or other serious adverse event due to treatment with XR-NTX
- Current psychotic disorder (bipolar, schizophrenia, major depression with suicidal ideation, or psychotic features) identified by clinical...
See the full eligibility criteria
- Age 18-65 years old
- Willing to provide signed, informed consent and commit to completing the study procedures
- Able to read at an 8th grade or higher level
- Current DSM-5 diagnosis of AUD
- Reports consuming 24+ standard drinks (men) or 18+ standard drinks (women) weekly on average over the month prior to consent
- Expresses a desire to reduce or stop drinking and a willingness to receive two injections of study medication over 8 weeks of treatment.
- Either a reward drinker [i.e., an individual with a score of 19 or greater on the reward subscale and less than or equal to 18 on the relief subscale of the Inventory of Drinking Situations (IDS)] or a relief drinker...
- Has a stable address in the local area; not planning to move; has documents for an ID check
- Women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or are less than two years postmenopausal): must be non-lactating and practicing a reliable method of birth...
- Planned surgery within the timeframe of the study
- A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it...
- Chronic or episodic painful conditions that could require opioid medications for pain control
- History of seizure disorder (excluding childhood febrile seizures)
- History of allergy or other serious adverse event due to treatment with XR-NTX
- Current psychotic disorder (bipolar, schizophrenia, major depression with suicidal ideation, or psychotic features) identified by clinical examination or the structured interview that could interfere with study...
- Current DSM-5 diagnosis of any drug use disorder other than alcohol, nicotine, or cannabis or a urine drug screen that is positive for benzodiazepines, opioids, amphetamines, cocaine or barbiturates.
- Current treatment with a psychotropic, anticonvulsant, opioid, anticoagulant or AUD treatment medication (i.e., naltrexone, acamprosate, disulfiram, topiramate, gabapentin, varenicline, or baclofen)
- Receipt of any experimental medication within the past 30 days
- In need of medical detoxification from alcohol
- people cannot have been mandated by court for alcohol or drug abuse treatment or have pending legal proceedings that could result in incarceration within 6 months of enrollment.
- Homicidal or other behavioral disturbance that requires immediate clinical attention
- Judged by the principal investigator or his designee to be an unsuitable candidate for study participation
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, 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.