Evaluating different doses of naltrexone for alcohol use disorders

Exploring the Pharmacokinetic Characteristics of Different Doses of Naltrexone Implants in Patients With Alcohol Use Disorders

This study is testing different doses of naltrexone implants to see how well they help people with alcohol use disorders.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shenzhen Sciencare Medical Industries Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Changsha, 湖南省)
• Trial ID: NCT05919017 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the pharmacokinetics (PK) of various doses of naltrexone implants in patients diagnosed with alcohol use disorders (AUD). It is a multicenter, randomized, double-blind, placebo-controlled phase II study that will enroll 60 participants. Blood samples will be collected at multiple time points to analyze the drug's characteristics and efficacy. The study will also ensure that participants have completed withdrawal treatment and are stable before administration.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with moderate to severe alcohol use disorders who have completed withdrawal treatment.

Not a fit: Patients with mild alcohol use disorders or those currently experiencing withdrawal symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for individuals struggling with alcohol use disorders.

How similar studies have performed: Other studies have shown promise in using naltrexone for alcohol use disorders, indicating that this approach has potential based on previous findings.

Eligibility criteria

Selection criteria:

1. Volunteer to participate in clinical research; Fully understand and be informed of this experiment and sign informed consent; Willing to follow and capable of completing all testing procedures;
2. The age at the time of signing the informed consent form is ≥ 18 years old;
3. Patients diagnosed as moderate to severe alcohol use disorders based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (four or more items that meet the diagnostic criteria);
4. Have completed withdrawal treatment and have no obvious alcohol withdrawal symptoms for at least one week (≥ 7 days) before randomization/administration \[Clinical Institute Alcohol Dependence Withdrawal Assessment Form (CIWA-Ar) score\<7 points\];
5. Able to provide TLFB alcohol consumption information 2 weeks prior to withdrawal and/or screening;
6. During the 4-week period before withdrawal and/or screening, drink heavily at least twice a week;

Qualified subjects of childbearing age (male and female) must agree to take effective contraceptive measures (hormone or barrier therapy or abstinence) with their partners during the trial period.

Exclusion criteria:

Participants who meet any of the following criteria cannot be selected for the experiment:

1. The researcher determines that participating in this experiment does not comply with the rights and interests of the subjects, or any other circumstances that do not allow the subjects to conduct the study safely;
2. Pregnant and reproductive age women with positive pregnancy tests or lactating women, including those who planned to conceive during the study period. Note: Here, women of childbearing age refer to women with fertility. The following criteria must be met, regardless of their sexual orientation or whether they have undergone tubal ligation: 1) have not undergone hysterectomy or bilateral ovariectomy; Or 2) Have not experienced natural menopause for more than 12 consecutive months (i.e., have menstruated at any time during the previous 12 consecutive months);
3. Significant abnormalities in liver function (such as AST or ALT exceeding twice the upper limit of normal values) or liver failure (including but not limited to: abdominal fluid accumulation, prolonged prothrombin time, international standard ratio (INR) ≥ 1.7, esophageal varicose disease) or liver and gallbladder ultrasound display results have a significant impact on the judgment of the efficacy and safety of the study drug;
4. Suffering from uncontrollable active infectious diseases in clinical practice, such as active hepatitis B (positive for hepatitis B surface antigen (HBsAg) detection and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) copy number\>1000 IU/ml), active hepatitis C (positive for hepatitis C virus antibody and hepatitis C virus (HCV) ribonucleic acid (RNA)), etc;
5. A history of congenital hemorrhagic disease (such as hemophilia) or any clinically significant bleeding, or abnormal platelet function, or prothrombin time (PT) exceeding the upper limit of normal values by more than 3 seconds (sec) during coagulation function testing, or platelet count\<50 × 109/L；
6. Previous history of severe pancreatitis or severe tremor delirium episodes;
7. According to the judgment of the researchers, the subjects have any severe/uncontrollable systemic diseases (such as respiratory, circulatory, digestive, nervous, hematological, urogenital, endocrine system diseases) or mental illnesses (such as severe depression, schizophrenia, bipolar disorder, etc.) or other major diseases that the researchers believe will hinder the provision of informed consent and make participation in the study unsafe Complicating the interpretation of research outcome data or otherwise affecting the achievement of research objectives;
8. Hospitalization or surgery may be required during the study period, including planned elective surgery or hospitalization that cannot be postponed;
9. According to the DSM-5 standard, currently diagnosed (within one year prior to randomization/administration) with substance use disorders other than alcohol, such as benzodiazepines, amphetamines, opioids, or cocaine;
10. Within 30 days before randomization/administration, I have taken drugs to prevent relapse (such as naltrexone) or received systematic psychological support treatment;
11. Currently undergoing treatment for opioid, amphetamine, alcohol, and other substance use disorders, or receiving opioid treatment within 7 days before randomization/administration, opioid treatment may be required during the study period, or on the day of randomization/administration, urine opioid, marijuana, amphetamine, and other drugs tested positive or naloxone challenge test positive;
12. Allergies to research drugs or their excipients (polylactic acid, magnesium stearate), local anesthetics;
13. Participating in any study drug or device research, or having used any study drug or device within 30 days prior to randomization/administration;
14. If there is a skin infection or systemic skin disease at the site of implantation surgery, it is determined that it can affect the effectiveness and safety evaluation of the study drug;
15. Clinical or laboratory evidence suggests that human immunodeficiency virus (HIV) or syphilis are carried/infected.

Where this trial is running

Changsha, 湖南省

• Hunan Second People's Hospital — Changsha, 湖南省, China (Recruiting)

Study contacts

• Principal investigator: zou xuhui, Dr — Hunan Second People's Hospital
• Study coordinator: zou xuhui, Dr

Conditions AUD