Deep Brain Stimulation of the Bilateral Nucleus Accumbens for Patients With Methadone Maintenance Treatment

Shanghai Jiao Tong University

Status: Unknown

Conditions: Addiction Opiate

Treatments: Procedure: Bilateral surgical implantation of DBS system to Nucleus Accumbens

Study type: Interventional

Funder types: Other

Identifiers

NCT03952455

2019 NAc-DBS MMT

Details and patient eligibility

About

Methadone maintenance treatment (MMT) is one of the main forms of treatments for opioid dependence. Despite its effectiveness and widespread use, people will experience withdrawal if daily dose is insufficient or missed, promoting reluctance to attempt detoxification. In addition, methadone is a full opioid agonist which can induce respiratory depression or sedation without ceiling level, so overdose usage can be fatal. Hence, an alternative therapy is needed to completely reduce the carving for drugs and to relieve the negative affective sate caused by withdrawal.

Deep brain stimulation (DBS) is a reasonable treatment approach for addiction. Since 2009 the first case report emerged, the nucleus accumbens (NAc) is still the only brain target to be investigated in clinical case series of DBS for alcohol and heroin addiction.

This research will mainly investigate the effectiveness and safety of NAc-DBS for patients with methadone maintenance treatment. The investigators will also explore the influence of NAc-DBS on brain activity and cognition.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• MINI diagnosis of substance dependence;
• Proficiency in Mandarin language;
• Failure to detox more than three times;
• Long-term methadone maintenance treatment;
• Capacity to provide informed consent (understanding of the study purpose and methods);

Exclusion criteria

• Schizophrenia(MINI diagnosis);
• Antisocial personality disorder(MINI diagnosis);
• Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator;
• Severe cognitive impairments(MoCA ≤ 22);
• Enrollment in other clinical trials;
• Stereotactic respectively neurosurgical intervention in the past;
• Contraindications of stereotactic intervention, e.g. increased bleeding disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases);
• Serious or instable organic diseases (e.g. instable coronal heart disease);
• Tested positively for HIV;
• Pregnancy and/or lactation;
• Epilepsy or other severe brain trauma or neurological impairments;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

DBS

Experimental group

Description:

All subjects will undergo bilateral surgical implantation of DBS system in the Nucleus Accumbens. The DBS system will be active at two days after surgery.

Treatment:

Procedure: Bilateral surgical implantation of DBS system to Nucleus Accumbens