New shot may curb heavy drinking in reward-driven people
NCT ID NCT05028062
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a monthly injection of naltrexone (a medication that blocks alcohol's rewarding effects) helps people who drink for pleasure reduce heavy drinking more than a placebo. About 60 adults with alcohol use disorder who drink heavily will receive either the shot or a placebo, plus four counseling sessions. The goal is to see if the medication leads to fewer heavy drinking days over 8 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 (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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pennsylvania Center for Studies of Addiction
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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- Brain scans probe opioid receptor imbalance in alcohol use disorder
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