NCT03952455

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 10, 2020

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

May 14, 2019

Last Update Submit

January 7, 2020

Conditions

Addiction Opiate

Keywords

Nucleus AccumbensDeep brain stimulationMethadone

Outcome Measures

Primary Outcomes (1)

  • Changes in Methadone dose

    The volume of daily methadone the patients used.

    Baseline (preoperative),1 month, 3 months,6 months,9 months, 12 months

Secondary Outcomes (16)

  • Hamilton Depression Scale(HAMD-17)

    Baseline(preoperative),1 month, 3 months, 6 months, 9 months, 12 months

  • Hamilton Anxiety Scale (HAMA)

    Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months

  • Young Manic Rating Scale (YMRS)

    Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months

  • Monitoring of Side Effects Scale (MOSES)

    Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months

  • Changes in Subjective Opiate Withdrawal Scale(SOWS)

    Baseline(preoperative),1 month, 3 months, 6 months,9 months, 12 months

  • +11 more secondary outcomes

Other Outcomes (2)

  • Barratt impulsiveness scale

    Baseline(preoperative)

  • UPPS-P impulsive behavior scale

    Baseline(preoperative)

Study Arms (1)

DBS

EXPERIMENTAL

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.

Procedure: Bilateral surgical implantation of DBS system to Nucleus Accumbens

Interventions

Bilateral surgical implantation of DBS system to Nucleus AccumbensPROCEDURE

We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).

DBS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ruijin Hospital Functional Neurosurgery

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23227826BACKGROUND

  • 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.

    PMID: 23337942BACKGROUND

  • 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.

    PMID: 27145161BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Functional Neurosurgery

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 16, 2019

Study Start

May 13, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

January 10, 2020

Record last verified: 2019-05

Locations

CN(1)