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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
XR-NTX 380 mg, intramuscular injection
DrugTwo doses of XR-NTX 380 mg, intramuscular injection.
Medical Management
BehavioralAll 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.
Placebo intramuscular injection
DrugTwo doses of XR-NTX 380 mg, intramuscular injection.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: XR-NTX 380 mg, intramuscular injectionActive comparator 2 interventions
Group B: Inactive placebo intramuscular injectionPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Frequency of heavy drinking days by medication group (timeline follow back calendar).
The number of Heavy Drinking Days during 8 weeks of treatment in the Naltrexone and placebo groups.
Time frame
8 weeksSecondary outcomes
1
Frequency of drinking days, and drinks/drinking day by medication group (timeline follow back calendar).
The number of Drinking Days, drinks/drinking day by medication group during 8 weeks of treatment in the Naltrexone and placebo groups.
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
Alkermes, Inc.
Collaborator
Source ClinicalTrials.gov