Actively Recruiting
Naltrexone in AUD Reward Drinkers
Led by University of Pennsylvania · Updated on 2026-01-20
60
Participants Needed
1
Research Sites
329 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
A
Alkermes, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Naltrexone in AUD Reward Drinkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years old
- Willing to provide signed, informed consent and complete study procedures
- Able to read at an 8th grade level or higher
- Current DSM-5 diagnosis of alcohol use disorder
- Men report consuming 24 or more standard drinks weekly; women report 18 or more weekly on average over the prior month
- Desire to reduce or stop drinking and willingness to receive two study medication injections over 8 weeks
- Identified as either a reward drinker (score 19+ on reward subscale and 18 or less on relief subscale of Inventory of Drinking Situations) or a relief drinker (score 21+ on relief subscale and 18 or less on reward subscale)
- Stable local address with plans to remain and valid ID for verification
- Women of childbearing potential must be non-lactating, use reliable birth control, and have a negative urine pregnancy test before starting
You will not qualify if you...
- Planned surgery during the study period
- Significant physical disease or abnormal lab results that could interfere with participation or pose risks (e.g., bleeding disorders, pancreatitis, epilepsy, diabetes, liver or kidney disease, cardiomyopathy)
- Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels more than 3 times the upper limit of normal or elevated direct bilirubin
- Chronic or episodic pain conditions requiring opioid pain medications
- History of seizure disorder (excluding childhood febrile seizures)
- Allergy or serious adverse reaction to XR-NTX
- Current psychotic disorder impacting safety or participation
- Current diagnosis of any drug use disorder other than alcohol, nicotine, or cannabis, or positive urine drug screen for benzodiazepines, opioids, amphetamines, cocaine, or barbiturates
- Current treatment with psychotropic, anticonvulsant, opioid, anticoagulant, or alcohol use disorder medications
- Use of any experimental medication in the past 30 days
- Need for medical detoxification from alcohol
- Court-mandated alcohol or drug treatment or pending legal issues risking incarceration within 6 months
- Behavioral disturbances requiring immediate clinical attention
- Judged unsuitable for study participation by the principal investigator or designee
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
T
Timothy S Pond, MPH
CONTACT
R
Rachel Weyl, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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