Naltrexone for Alcohol Use Disorder in Reward Drinkers
This study is looking at whether a medication called naltrexone (XR-NTX 380 mg), given as an injection, can help people who drink heavily reduce their drinking. You would receive either two doses of naltrexone or a placebo (an inactive injection that looks the same) over 8 weeks. Everyone in the study will also receive 8 weeks of Medical Management, which involves support and recommendations to help you reduce or stop drinking. The main goal is to see if naltrexone helps reduce the number of heavy drinking days compared to the placebo. You might be able to join if you are 18-65 years old, have an Alcohol Use Disorder (AUD), drink a certain amount weekly, and want to reduce or stop drinking. The study is currently unclear on its recruitment status.
- Study design
- This is a randomized, double-blind study, meaning you would be randomly assigned to receive either naltrexone or a placebo, and neither you nor the study staff would know which you are getting. It plans to enroll 60 participants.
- What's involved
- You would have an initial screening visit lasting about three hours, which may include a physical exam, blood and urine tests, and a breathalyzer test. You would also receive two injections and participate in 8 weeks of Medical Management sessions.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have follow-up visits for 4 weeks after your treatment is completed.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05028062
Naltrexone in AUD Reward Drinkers
Recruiting
PHASE4Ages 18–65InterventionalTreatmentUniversity of PennsylvaniaInvestigator-initiated
~60 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:XR-NTX 380 mg, intramuscular injectionMedical ManagementPlacebo intramuscular injection
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of heavy drinking days by medication group (timeline follow back calendar).
Measured over 8 weeks
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Henry R Kranzler, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 (i.e., an individual with a score of 21 or greater on the relief subscale and less than or equal to 18 on the reward subscale of the IDS).
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 control and have a negative urine pregnancy test prior to the initiation of the study procedures. Examples of medically acceptable methods for this protocol include oral contraceptive pills, intrauterine device, injection of Depo-Provera, Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such as condoms and diaphragm/spermicide), male partner sterilization, abstinence (and agreement to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence).
Exclusion
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 hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, diabetes, liver disease, kidney disease, or cardiomyopathy as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or direct bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once).
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 participation or make it hazardous for the subject.
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
Subjects 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
What this trial measures
- Frequency of heavy drinking days by medication group (timeline follow back calendar).8 weeks
The number of Heavy Drinking Days during 8 weeks of treatment in the Naltrexone and placebo groups.