Your session is about to expire
← Back to Search
Naltrexone Injection for Alcoholism
Phase 4
Recruiting
Led By Henry R Kranzler, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-65 years old
Reports consuming 24+ standard drinks (men) or 18+ standard drinks (women) weekly on average over the month prior to consent
Must not have
Planned surgery within the timeframe of the study
Chronic or episodic painful conditions that could require opioid medications for pain control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will test whether an injection of naltrexone reduces heavy drinking in people who are 'reward drinkers'.
Who is the study for?
Adults aged 18-65 with Alcohol Use Disorder (AUD) who drink heavily and want to cut down or stop. They must be able to understand the study, have a stable address, and use reliable birth control if applicable. Excluded are those with certain mental health conditions, on conflicting medications, facing potential incarceration soon, having significant physical diseases or abnormal lab results, drug disorders other than alcohol/nicotine/cannabis, needing detoxification from alcohol or with a history of bad reactions to XR-NTX.
What is being tested?
The trial is testing whether long-acting injectable naltrexone (XR-NTX) helps people who primarily drink for pleasure more than a placebo in reducing heavy drinking. Participants will receive either XR-NTX or placebo injections monthly along with four sessions of Medical Management counseling over eight weeks.
What are the potential side effects?
Possible side effects include nausea, headache, dizziness, fatigue, injection site pain or reaction. There may also be risks related to liver function changes as well as rare but serious allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have been drinking more than the recommended amount of alcohol weekly.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am scheduled for surgery during the study period.
Select...
I have chronic pain that might need opioids for management.
Select...
I have a history of seizures, not including childhood febrile seizures.
Select...
I am currently taking medication for mental health, seizures, pain, blood thinning, or alcohol use disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency of heavy drinking days by medication group (timeline follow back calendar).
Secondary study objectives
Frequency of drinking days, and drinks/drinking day by medication group (timeline follow back calendar).
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: XR-NTX 380 mg, intramuscular injectionActive Control2 Interventions
Subjects will receive an injection of XR-NTX 380 mg (4 mL) repeated once after 4 weeks.
Group II: Inactive placebo intramuscular injectionPlacebo Group2 Interventions
Subjects will receive a placebo injection repeated once after 4 weeks.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,988 Total Patients Enrolled
27 Trials studying Alcoholism
3,620 Patients Enrolled for Alcoholism
Alkermes, Inc.Industry Sponsor
115 Previous Clinical Trials
26,919 Total Patients Enrolled
14 Trials studying Alcoholism
3,137 Patients Enrolled for Alcoholism
Henry R Kranzler, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
344 Total Patients Enrolled
2 Trials studying Alcoholism
343 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any major health issues that could make joining the study unsafe for me.I am between 18 and 65 years old.I am using reliable birth control and not pregnant if I can have children.I want to cut down or stop drinking and am open to getting 2 shots over 8 weeks.I am scheduled for surgery during the study period.I have chronic pain that might need opioids for management.I have a history of seizures, not including childhood febrile seizures.I am currently taking medication for mental health, seizures, pain, blood thinning, or alcohol use disorder.I have been drinking more than the recommended amount of alcohol weekly.
Research Study Groups:
This trial has the following groups:- Group 1: XR-NTX 380 mg, intramuscular injection
- Group 2: Inactive placebo intramuscular injection
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.