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Sublingual Dexmedetomidine for Opioid Withdrawal
Study Summary
This trial will study a new non-opioid medication to ease opioid withdrawal symptoms like anxiety, nausea, and insomnia. It will compare safety and efficacy against a current non-opioid and placebo in OUD patients.
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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- You have a severe psychiatric disorder, such as depression or mania, that may make it difficult for you to complete the study requirements.You have participated in another clinical trial with a drug in the last 30 days before screening.I have a history of significant heart issues or my heart rate/blood pressure doesn't meet the specified range.I cannot provide a drug-free urine test for methadone or buprenorphine.I have liver issues, such as fluid in the abdomen, high bilirubin, or swollen veins in my esophagus.I have taken oral naltrexone for at least a week in the last two months.I am not on any medication that could affect my safety or the study's results.I understand and can follow the study's requirements.I am between 18 and 60 years old.I agree to use birth control during the study.You currently need to stop drinking alcohol or taking benzodiazepines, and require medical assistance to do so.
- Group 1: Lofexidine (Positive Control)
- Group 2: BXCL501 (240 micrograms)
- Group 3: BXCL501 (180 micrograms)
- Group 4: Placebo
- 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
Does this clinical investigation cater to adults above 18 years of age?
"Eligible participants must be of the age of majority or older, but not exceeding 60 years."
Is there an opportunity for individuals to volunteer as participants in this medical experiment?
"According to clinicaltrials.gov, this current medical trial went live on February 28th 2023 and was last modified a month later on March 27th of the same year. The study is actively seeking participants for enrolment."
Is it possible for me to join this research endeavor?
"This investigation seeks 160 eligible participants with opioid withdrawal syndrome between ages 18 and 60. Those wishing to apply must be capable of adhering to the study protocol, have a DSM-V diagnosis of moderate or severe opioid use disorder, demonstrate physiological dependence on opioids, and female applicants will need to agree upon using contraception for the duration of the trial."
What is the current sample size of this research trial?
"Correct. According to the clinicaltrials.gov records, this medical trial opened on February 28th 2023 and is still recruiting patients as of March 27th 2023. A total of 160 people must be enrolled at one designated location for the study to proceed."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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