Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention

Addiction Clinical Trial

Official title:

Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention:A Multicenter Randomized Double-Blind Sham-stimulation Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03424616
• Other study ID #: NAcDBSORP
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2018
• Last updated: January 31, 2018
• Start date: February 6, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: January 2018
• Source: Tang-Du Hospital
• Contact: Guodong Gao, M.D.
• Phone: +86 29 84717556
• Email: gguodong[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification.According to the single-centered preliminary open-labeled prospective trial results, the investigators hypothesize that bilateral stimulation of the NAc will effectively reduce the relapse of the opiate dependence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18 years old < Age < 50 years old

• Moderate to severe opiates abuse disorders (fulfilled diagnostic-criteria according to DSM-5)

1. History of opiates abuse no less than 3 years

2. Failure of at least three addiction treatments ( in hospital or compulsive rehabilitation), among which failure of methadone maintenance treatment must be met

3. completion of detoxification ( Negative urine test for morphine, methamphetamine, ketamine and buprenorphine)

• Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance, known the benefit and risk of the treatment)

Exclusion Criteria:

• Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)

• Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator

• Abuse of other type of drugs

• severe cognitive impairments

• Enrollment in other clinical trials

• Stereotactic respectively neurosurgical intervention in the past

• Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)

• Serious and instable organic diseases (e.g. instable coronal heart disease)

• tested positively for HIV

• pregnancy and/or lactation

• Severe disorders for coagulation and liver function

• Epilepsy or other severe brain trauma or neurological impairments

Related Conditions & MeSH terms

• Addiction

Intervention

Device:
• Suzhou Sceneray® DBS System
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.

Locations

Country	Name	City	State
China	National Institute on Drug Dependence, Peking University	Beijing	Beijing
China	West China Hospital	Chengdu	Si Chuan
China	Nanfang Hospital Southern Medical University	Guangzhou	Guangdong
China	Ruijin Hospital	Shanghai	Shanghai
China	Department of neurosurgery, Tangdu Hospital	Xi'an	Shaanxi

Sponsors (6)

Lead Sponsor	Collaborator
Tang-Du Hospital	Nanfang Hospital of Southern Medical University, National Institute on Drug Dependence, Peking University, Peking University First Hospital, Ruijin Hospital, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The abstinent rate at 25 weeks after DBS stimulation on (Urine Tests)	If the participants or their families report no less than 2 times of the drug use in each of two consecutive weeks, or the consecutive 2 times of urine tests showed positive, or lost of follow-up, the case was defined as relapse	At 25 weeks after DBS stimulation on
Secondary	The total days of abstinence for participants	The total days of abstinence for participants	Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	The longest duration for sustained abstinence for participants	The longest duration for sustained abstinence for participants	Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	Visual analog scale (VAS) craving score for opioid drugs	Ranging from 0-10,with 0 indicates no craving while 10 indicates extreme craving	Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	Body weight for participants	Body weight for participants	Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	Hamilton Depression Scale(HAMD-17)	17 items,Total scores<7: normal;7	Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	Scaling for Opiate withdrawal symptoms	There were 19 items for rating 19 withdrawl symptoms, with 0 indicating none and 4 indicating most severe, the total scores are obtained by summary for scores of each items, ranging from 0-76, the higher the total scores indicating the worsen opiate withdrawl symptoms.	Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	The evaluation on MATRICS-test	Software system constructed by MATRICS company, which was used for evaluate the cognitive function of the participants	Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	The rate of positive urine test results	times of positive urine test/ total times of urine test	Baseline (preoperative), 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	Hamilton Anxiety Scale (HAMA)	14 items, Total scores<6: normal;7	Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	Pittsburgh sleep quality index(PSQI)	Scaling for evaluating the sleep quality, the higher total scores indicating the more difficulties on sleep, thus the higher total scores indicating the worsen sleep quality	Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	Fagerstrom Test Nicotine Dependence assessment (FTND)	Scaling for Nicotine Dependence: The higher of scores indicating higher lever of Nicotine Dependence	Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	Social Disability Screening Schedule (SDSS)	Scaling for Social Disability with 10 items, the higher total scores indicating the much severe social disability	Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	Activity of Daily Living Scale (ADL)	Consists of Physical Self-maintenance Scale and Instrumental Activities of Daily Living Scale, ranging from 0-56, total scores <14, normal; total score >14, ADL dysfunction	Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on
Secondary	36-Item Short Form Health Survey (SF-36)	Scaling for Quality of life with 8 subscales, the higher total scores indicating the better quality of life.	Baseline (preoperative), 1week, 4 weeks, 12 weeks, 25 week after DBS stimulation on