Naltrexone in AUD Reward Drinkers
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- XR-NTX 380 mg, intramuscular injection
- Medical Management
- Placebo intramuscular injection
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
Alkermes, Inc.
Collaborator
Source ClinicalTrials.gov