Clinical trial NCT03952455: Deep Brain Stimulation of the Bilateral Nucleus Accumbens for Patients With Methadone Maintenance Treatment
Official title: Deep Brain Stimulation of the Bilateral Nucleus Accumbens for Patients With Methadone Maintenance Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Addiction Opiate
Keywords: Nucleus Accumbens
Deep brain stimulation
Methadone
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Changes in Methadone dose
timeFrame: Baseline (preoperative),1 month, 3 months,6 months,9 months, 12 months
Secondary outcomes:
measure: Hamilton Depression Scale(HAMD-17)
timeFrame: Baseline(preoperative),1 month, 3 months, 6 months, 9 months, 12 months
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months
measure: Young Manic Rating Scale (YMRS)
timeFrame: Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months
measure: Monitoring of Side Effects Scale (MOSES)
timeFrame: Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months
measure: Changes in Subjective Opiate Withdrawal Scale(SOWS)
timeFrame: Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months
measure: Obsessive compulsive drug use scale(OCDUS)
timeFrame: Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months
measure: The MOS item short from health survey (SF-36)
timeFrame: Baseline(preoperative),1 month, 3 months,6 months,9 months, 12 months
measure: World Health Organization Quality of Life-BREF (WHO-BREF)
timeFrame: Baseline(preoperative),1 month, 3 months,6 months,9 months, 12 months
measure: Fagerstrom Test for Nicotine Dependence assessment (FTND)
timeFrame: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months
measure: Beck depression inventory(BDI)
timeFrame: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months
measure: Beck anxiety inventory(BAI)
timeFrame: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months
measure: Perceived stress scale(PSS-10)
timeFrame: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months
measure: Twenty Item Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months
measure: Work and Social Adjustment Scale(WSAS)
timeFrame: Baseline(preoperative),1 month, 3months,6months,9 months, 12 months
measure: Cognitive performance
timeFrame: Baseline(preoperative),6 months,12 months
measure: Brain activity
timeFrame: Baseline(preoperative), 6 months,12 months
Other outcomes:
measure: Barratt impulsiveness scale
timeFrame: Baseline(preoperative)
measure: UPPS-P impulsive behavior scale
timeFrame: Baseline(preoperative)
Locations:
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital Functional Neurosurgery
state: Shanghai
Study officials:
References:
citation: Muller UJ, Voges J, Steiner J, Galazky I, Heinze HJ, Moller M, Pisapia J, Halpern C, Caplan A, Bogerts B, Kuhn J. Deep brain stimulation of the nucleus accumbens for the treatment of addiction. Ann N Y Acad Sci. 2013 Apr;1282:119-28. doi: 10.1111/j.1749-6632.2012.06834.x. Epub 2012 Dec 10.
citation: Kuhn J, Moller M, Treppmann JF, Bartsch C, Lenartz D, Gruendler TO, Maarouf M, Brosig A, Barnikol UB, Klosterkotter J, Sturm V. Deep brain stimulation of the nucleus accumbens and its usefulness in severe opioid addiction. Mol Psychiatry. 2014 Feb;19(2):145-6. doi: 10.1038/mp.2012.196. Epub 2013 Jan 22. No abstract available.
citation: Muller UJ, Sturm V, Voges J, Heinze HJ, Galazky I, Buntjen L, Heldmann M, Frodl T, Steiner J, Bogerts B. Nucleus Accumbens Deep Brain Stimulation for Alcohol Addiction - Safety and Clinical Long-term Results of a Pilot Trial. Pharmacopsychiatry. 2016 Jul;49(4):170-3. doi: 10.1055/s-0042-104507. Epub 2016 May 4.