None
Conditions
Interventions
Experimental group:1.5 g of naltrexone hydrochloride was surgically implanted subcutaneously into the abdomen
Sponsors
Second Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign the informed consent form and be capable of complying with the follow-up schedule and completing study assessments; 2.Male or female subjects aged 18 to 65 years (inclusive); 3.Meet the diagnostic criteria for Opioid Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), meet the diagnostic criteria for opioid withdrawal, and have completed detoxification treatment; 4.Test negative in the qualitative urine test for opioids; 5.Have abstained from opioid use for 7–14 days and tested negative on the naloxone challenge test.
Exclusion criteria
Exclusion criteria: (1) known or suspected allergic or serious adverse reactions to naltrexone hydrochloride and its excipients; (2) women who are pregnant, lactating, or of childbearing age who plan to become pregnant during the study period; (3) significant abnormal liver function (e.g., AST or ALT > 3 times the upper limit of normal) or liver failure (including but not limited to: Ascites, prolonged prothrombin time, international normalized ratio (INR) >=1.7, esophageal varices disease, or the results of hepatobiliary B-ultrasound had a greater impact on the judgment of the efficacy and safety of the study drugs. (4) patients with clinically uncontrolled active infectious diseases, such as active hepatitis B [hepatitis B surface antigen (HBsAg) positive, and hepatitis B virus (HBV) DNA copy number > 1000 IU/ml], active hepatitis C [hepatitis C virus antibody positive, And hepatitis C virus (HCV) -RNA positive]; (5) clinical or laboratory evidence of human immunodeficiency virus (HIV) or syphilis infection; (6) The participant has any severe/uncontrollable systemic or mental illness (including suicide risk/severe depression) or other serious medical conditions that the investigator considers would prevent the provision of informed consent, make the study participation unsafe, or affect the study results; (7) patients using opioid analgesics; (8) patients currently receiving opioid replacement therapy; (9) patients with thrombocytopenia or any coagulation disorders such as hemophilia and severe liver failure; (10) diabetic patients with severe complications; (11) patients with surgical treatment plan during treatment; (12) patients with severe scar constitution and highly allergic; (13) skin infection at the implantation site or systemic skin disease, which could affect the efficacy and safety evaluation of the study drug; (14) are participating in a study drug or device, or have used a study drug or device within 30 days before dose; (15) other conditions considered by the investigator to be inappropriate for participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the relapse rate of opioids in patients at 24 weeks;To evaluate the incidence and severity of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the proportion of patients with negative urine drug tests for opioids at 12 weeks;Evaluate the proportion of patients with negative urine drug tests for opioids at 20 weeks;Evaluate the proportion of days with no opioid use;Evaluate the change in psychological craving scores; | — |
Countries
China
Contacts
Public ContactHao Wei
The Second Xiangya Hospital, Central South University
Outcome results
None listed