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Clinical trial of implantable neural stimulation system for preventing relapse after drug addiction withdrawal

Clinical trial of implantable neural stimulation system for preventing relapse after drug addiction withdrawal

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062728
Enrollment
Unknown
Registered
2022-08-16
Start date
2022-08-15
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Addiction

Interventions

Sponsors

The Affiliated Brain Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Enrollment age: 18-50 years old, no gender limitation; 2. Meet the diagnostic criteria of moderate to severe substance use disorder in DSM-5, and meet the following conditions: (1) Drug addiction course of 3 years or more; (2) Three or more times of drug treatment (medical institutions or compulsory drug treatment) failure; (3) After physiological detoxification treatment (after 14 days), urine tests of morphine, methamphetamine, ketamine, methadone and buprenorphine were negative; 3. The patient and his/her relatives or spouse have fully understood the purpose, significance, efficacy, complications and possible risks of the operation and voluntarily request surgical treatment; 4. The patient and his/her relatives have good compliance, and their relatives can assist researchers to complete follow-up and sign informed consent; 5. Sign the informed consent of the subject.

Exclusion criteria

Exclusion criteria: 1. Patients with other drug dependence (except tobacco dependence); 2. The subjects have no strong willingness to voluntarily detoxify themselves; 3. Have severe cognitive impairment (MMSE score: illiteracy < 17, primary school < 20, junior high school < 24); 4. Patients with other mental diseases (including drug-induced mental disorders); 5, Have a history of active epilepsy (i.e., epileptic seizures), have suffered craniocerebral nervous system injury and other obvious neurological defects; 6. Abnormal blood pressure and blood sugar are difficult to control; preoperative anticoagulant drugs are being taken or clinical bleeding tendency is contraindicated; 7. Preoperative test values of main indexes of liver function were 3 times higher than the upper limit of normal value, and those of main indexes of renal function were 1.5 times higher than the upper limit of normal value; Patients diagnosed with malignant tumors; Serious heart disease; Unstable vital signs with BMI <= 12; 8. Confirmed HIV-positive persons; 9. Surgical history: such as stereotactic neuronucleotomy, implantation of similar products, etc., or other surgical procedures that researchers consider to have an impact on the study within six months; 10. Women who are pregnant or planning to be pregnant or breast-feeding; 11. The patient is participating in other clinical trials and has not obtained the clinical study endpoint; 12. The researcher considers it inappropriate to participate in this clinical research.

Design outcomes

Primary

MeasureTime frame
Relapse Rate;

Countries

China

Contacts

Public ContactFan Ni

The Affiliated Brain Hospital of Guangzhou Medical University

fanni2005@126.com+86 1802630968

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026