NCT05028062 · University of Pennsylvania
Naltrexone in AUD Reward Drinkers
What this study is about
This study is a phase IV, two-treatment group$1, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment 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.
View original scientific description
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. All subjects will also receive 4 sessions of Medical Management (MM). Post-treatment follow-up visits will be conducted at 4 weeks after the scheduled completion of treatment.
Interventions
DRUG
XR-NTX 380 mg, intramuscular injection
Two doses of XR-NTX 380 mg, intramuscular injection.
BEHAVIORAL
Medical Management
All subjects will receive 8 weeks of medical management (Pettinati et al. 2004) will support subjects' efforts to reduce or stop their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the subject's drinking, and make recommendations to follow until the next visit. Men will be advised to consume no more than 3 drinks 4 times per week; women will be advised to consume no more than 2 drinks 4 times per week.
DRUG
Placebo intramuscular injection
Two doses of XR-NTX 380 mg, intramuscular injection.
Primary outcome measures
Frequency of heavy drinking days by medication group (timeline follow back calendar).
Time frame: 8 weeks
The number of Heavy Drinking Days during 8 weeks of treatment in the Naltrexone and placebo groups.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Collaborators
Alkermes, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations