Deep Brain Stimulation of the Bilateral Nucleus Accumbens for Patients With Methadone Maintenance Treatment
- Conditions
- Addiction Opiate
- Interventions
- Procedure: Bilateral surgical implantation of DBS system to Nucleus Accumbens
- Registration Number
- NCT03952455
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
- 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);
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DBS Bilateral surgical implantation of DBS system to Nucleus Accumbens 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.
- Primary Outcome Measures
Name Time Method Changes in Methadone dose Baseline (preoperative),1 month, 3 months,6 months,9 months, 12 months The volume of daily methadone the patients used.
- Secondary Outcome Measures
Name Time Method Monitoring of Side Effects Scale (MOSES) Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months To evaluate side effects. The higher score means more severity of side effects.
Perceived stress scale(PSS-10) Baseline(preoperative),1 month, 3months,6months,9 months, 12 months The PSS-10 is a classic stress assessment instrument. Each item is rated on a 5-likert scale ranging form 0(never) to 4(often). Higher score indicate more severity of stress symptom.
Work and Social Adjustment Scale(WSAS) Baseline(preoperative),1 month, 3months,6months,9 months, 12 months Self-rated scale. The maximum score of the WSAS is 40, lower scores are better.
Obsessive compulsive drug use scale(OCDUS) Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months Obsessive compulsive drug use scale is a 13-item self-rating scale measuring opiate craving. The total score ranges from 0 to 52. The higher score indicates stronger carving.
Fagerstrom Test for Nicotine Dependence assessment (FTND) Baseline(preoperative),1 month, 3months,6months,9 months, 12 months To evaluate Nicotine Dependence. The higher of scores indicates higher level of Nicotine Dependence
Twenty Item Positive and Negative Affect Schedule (PANAS) Baseline(preoperative),1 month, 3months,6months,9 months, 12 months The PANAS contains two subscales: positive and negative subscale. Each item is rated on a 5-likert scale ranging from 1(Not at all) to 5(severely, it bothered me a lot).
Young Manic Rating Scale (YMRS) Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition.
Changes in Subjective Opiate Withdrawal Scale(SOWS) Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months Subjective Opiate Withdrawal Scale is a 16-item self-reported scale assessing severity of opiate withdrawal. Each item is rated on a 5-point Likert scale, ranging form 0(not at all) to 4(extremely).
Beck depression inventory(BDI) Baseline(preoperative),1 month, 3months,6months,9 months, 12 months The BDI contains 21 questions, each answer scored on a scale value of 0 to 3. 0-13: minimal depression;14-19:mild depression; 20-28:moderate depression; and 29-63:severe depression. Higher total score indicate more severe depressive symptoms.
Cognitive performance Baseline(preoperative),6 months,12 months Cognitive performance is measured by a series of tasks which include stop signal task, paired associated memory, spatial working memory, stocking of Cambridge, intra-extra dimensional set shift, Bart, Beads, Delay discounting task, model-based and model-free task, avoid-approach task, dot-probe task, drug rating task.
Hamilton Depression Scale(HAMD-17) Baseline(preoperative),1 month, 3 months, 6 months, 9 months, 12 months 17 items, Total scores\<7: normal; 7\<Total scores≤17: possible depression; 17\<Total scores≤24: definite depression; Total score\>24: severe depression
Hamilton Anxiety Scale (HAMA) Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months 14 items, Total scores\<6: normal; 7\<Total scores≤14: possible anxiety; 14\<Total scores≤21:definite anxiety; Total score\>21: severe anxiety
The MOS item short from health survey (SF-36) Baseline(preoperative),1 month, 3 months,6 months,9 months, 12 months 36 items. To evaluate the quality of life and the higher score indicates better quality of life.
World Health Organization Quality of Life-BREF (WHO-BREF) Baseline(preoperative),1 month, 3 months,6 months,9 months, 12 months 26 items. The higher score means the better quality of life.
Brain activity Baseline(preoperative), 6 months,12 months PET(Positron Emission Tomography) or fMRI(functional Magnetic Resonance Imaging) are used in this study.
Beck anxiety inventory(BAI) Baseline(preoperative),1 month, 3months,6months,9 months, 12 months The BAI contains 21 questions, each answer scored on a scale value of 0 to 3. 0-21: mild anxiety;22-35: moderate anxiety;36-63:severe anxiety. Higher total score indicate more severe anxiety symptoms.
Trial Locations
- Locations (1)
Shanghai Ruijin Hospital Functional Neurosurgery
🇨🇳Shanghai, Shanghai, China