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Naltrexone Injection for Alcoholism
Study Summary
This trial will test whether an injection of naltrexone reduces heavy drinking in people who are 'reward drinkers'.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: XR-NTX 380 mg, intramuscular injection
- Group 2: Inactive placebo intramuscular injection
- 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.
- 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.
Frequently Asked Questions
Has XR-NTX 380 mg, intramuscular injection been trialed in any other scientific studies?
"Presently, there are 46 ongoing clinical trials studying the effects of XR-NTX 380 mg, intramuscular injection with 12 at Phase 3. The bulk of research is being conducted in New york City, however a total of 161 sites have launched studies related to this medication."
Do I qualify to partake in this clinical experiment?
"This clinical trial is seeking around 60 volunteers with the diagnosis of alcoholism, aged between 18 and 65."
What therapeutic effects is XR-NTX 380 mg, intramuscular injection used to treat?
"XR-NTX 380 mg, intramuscular injection is often utilised to treat chronic weight management. Additionally, this medication can be beneficial for increasing physical activity levels, alleviating pain and promoting healthy dietary choices."
What is the scope of participation in this research endeavor?
"Affirmative. Clinicaltrials.gov data indicates that the recruitment for this medical trial, which was first released on March 7th 2022, is ongoing and seeking 60 patients from a single site."
Are there any adverse consequences to intramuscular infusion of XR-NTX 380 mg?
"There is ample clinical evidence supporting XR-NTX 380 mg, intramuscular injection's safety profile, thus it achieved a score of 3."
Does this trial accept participants who are younger than 70 years of age?
"All potential participants for this study must fall between the age bracket of 18 and 65 years old."
Is access to this trial open at the present moment?
"The clinical research trial is actively accepting patients, as indicated on the clinicaltrials.gov website. The study was first announced on March 7th 2022 and underwent its last update on June 6th 2022."
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