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Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence (THED)

Primary Purpose

Heroin Dependence

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial magnetic stimulation and Cognitive behavioral therapy
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring Heroin dependence, transcranial magnetic stimulation, cognitive behavioral therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis as heroin dependence according to DSM-IV criteria
  • No definite history of neurological diseases and psychological problems
  • Volunteer to participate the study, cooperate to be followed up

Exclusion Criteria:

  • Acute withdrawal state and CIWA score > 9
  • With other neurological diseases and psychological problems
  • With ever brain trauma and damage
  • With other psychological medications or other substance dependence
  • With other contraindications to have transcranial magnetic stimulation

Sites / Locations

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Regular treatment (symptomatic treatment) with blank TMS

Regular treatment (RT) with blank TMS and CBT

RT with right DLPFC hf-rTMS

RT with right DLPFC hf-rTMS and CBT

RT with left DLPFC hf-rTMS

RT with left DLPFC hf-rTMS and CBT

Arm Description

Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation

Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy

Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS)

Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)

Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS)

Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)

Outcomes

Primary Outcome Measures

Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital

Secondary Outcome Measures

Duration of abstinence
The total time or period without any intake of heroin during follow-ups
Heroin consumption
Diaries of heroin intake in different time of the follow-ups
Craving for heroin
Craving assessment for heroin by Heroin Craving Questionnaire (HCQ) ranging from 0 to 175. Higher score of HCQ indicates more desire for heroin.
Craving for heroin
Craving assessment by Visual Analogue Scale (VAS) for heroin desire ranging 0 to 10. Higher score indicates more desire for heroin.
Cognitive assessment
Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
Psychological assessment - Anxiety
Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.
Psychological assessment - Depression
Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.
Psychological assessment - Sleep
Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.

Full Information

First Posted
April 17, 2019
Last Updated
March 19, 2021
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03922659
Brief Title
Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence
Acronym
THED
Official Title
Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Heroin dependence is one of most common substance dependence, which brings great burden on health worldwide. Heroin dependence may lead to immunosuppression and cognitive impairments. Once heroin dependence is developed, it will be difficult to recover and easy to relapse. Although many efforts had been made in the treatment of heroin dependence, the annual recurrence of heroin dependence with traditional therapies would be up to 90%. Repetitive transcranial magnetic stimulation (rTMS) on the dorsolateral prefrontal cortex (DLPFC) or cognitive behavioral therapy (CBT) each alone was reported to have some effect on preventing from relapse of substance dependence. In order to test whether combined therapy of high frequency rTMS (hf-rTMS) with CBT is better for preventing from relapse of heroin dependence, we recruit patients with heroin dependence to participate this study. The study is a factorial designed and the patients will be assigned into one of the following six groups randomly: (1) regular treatment (symptomatic treatment) with blank TMS; (2) regular treatment (RT) with blank TMS and CBT; (3) RT with right DLPFC hf-rTMS; (4) RT with right DLPFC hf-rTMS and CBT; (5) RT with left DLPFC hf-rTMS; (6) RT with left DLPFC hf-rTMS and CBT. TMS was given 5 days per week for total 2 weeks using uniform scheme (5 seconds of 10Hz stimulation per train, 30 trains per day with inter-train interval of 20 seconds). CBT will be given once per week for total 8 weeks. The patients will be followed up for 6 months. Recurrence of heroin dependence, duration of abstention, heroin/drug intake, craving for heroin and other cognitive psychological assessments will be recorded and compared among the 6 treatment groups and the efficacy of combined therapy of rTMS with CBT will be evaluated in our study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence
Keywords
Heroin dependence, transcranial magnetic stimulation, cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regular treatment (symptomatic treatment) with blank TMS
Arm Type
Placebo Comparator
Arm Description
Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation
Arm Title
Regular treatment (RT) with blank TMS and CBT
Arm Type
Active Comparator
Arm Description
Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy
Arm Title
RT with right DLPFC hf-rTMS
Arm Type
Active Comparator
Arm Description
Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
Arm Title
RT with right DLPFC hf-rTMS and CBT
Arm Type
Active Comparator
Arm Description
Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
Arm Title
RT with left DLPFC hf-rTMS
Arm Type
Active Comparator
Arm Description
Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
Arm Title
RT with left DLPFC hf-rTMS and CBT
Arm Type
Active Comparator
Arm Description
Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
Intervention Type
Combination Product
Intervention Name(s)
Transcranial magnetic stimulation and Cognitive behavioral therapy
Intervention Description
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Recurrence of heroin dependence
Description
The rate of relapse of heroin dependence after discharge from hospital
Time Frame
1 month
Title
Recurrence of heroin dependence
Description
The rate of relapse of heroin dependence after discharge from hospital
Time Frame
2 month
Title
Recurrence of heroin dependence
Description
The rate of relapse of heroin dependence after discharge from hospital
Time Frame
3 month
Title
Recurrence of heroin dependence
Description
The rate of relapse of heroin dependence after discharge from hospital
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Duration of abstinence
Description
The total time or period without any intake of heroin during follow-ups
Time Frame
6 months
Title
Heroin consumption
Description
Diaries of heroin intake in different time of the follow-ups
Time Frame
2 weeks, 1 month, 2 months, 3 months and 6 months
Title
Craving for heroin
Description
Craving assessment for heroin by Heroin Craving Questionnaire (HCQ) ranging from 0 to 175. Higher score of HCQ indicates more desire for heroin.
Time Frame
2 weeks, 1 month, 2 months, 3 months and 6 months
Title
Craving for heroin
Description
Craving assessment by Visual Analogue Scale (VAS) for heroin desire ranging 0 to 10. Higher score indicates more desire for heroin.
Time Frame
2weeks, 1 month, 2 months, 3 months and 6 months
Title
Cognitive assessment
Description
Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
Time Frame
2 weeks, 1 month, 2 months, 3 months and 6 months
Title
Psychological assessment - Anxiety
Description
Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.
Time Frame
2 weeks, 1 month, 2 months, 3 months and 6 months
Title
Psychological assessment - Depression
Description
Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.
Time Frame
2 weeks, 1 month, 2 months, 3 months and 6 months
Title
Psychological assessment - Sleep
Description
Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.
Time Frame
2 weeks, 1 month, 2 months, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis as heroin dependence according to DSM-IV criteria No definite history of neurological diseases and psychological problems Volunteer to participate the study, cooperate to be followed up Exclusion Criteria: Acute withdrawal state and CIWA score > 9 With other neurological diseases and psychological problems With ever brain trauma and damage With other psychological medications or other substance dependence With other contraindications to have transcranial magnetic stimulation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Peng, MD, PhD
Phone
+86-13380051581
Email
pengy2@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongxuan Wang, MD, PhD
Phone
+86-13824498978
Email
wanghx8@mail.sysu.edu.cn
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19524780
Citation
Phillips MR, Zhang J, Shi Q, Song Z, Ding Z, Pang S, Li X, Zhang Y, Wang Z. Prevalence, treatment, and associated disability of mental disorders in four provinces in China during 2001-05: an epidemiological survey. Lancet. 2009 Jun 13;373(9680):2041-53. doi: 10.1016/S0140-6736(09)60660-7.
Results Reference
background
PubMed Identifier
29189190
Citation
Makani R, Pradhan B, Shah U, Parikh T. Role of Repetitive Transcranial Magnetic Stimulation (rTMS) in Treatment of Addiction and Related Disorders: A Systematic Review. Curr Drug Abuse Rev. 2017;10(1):31-43. doi: 10.2174/1874473710666171129225914.
Results Reference
background
PubMed Identifier
26995024
Citation
Shen Y, Cao X, Tan T, Shan C, Wang Y, Pan J, He H, Yuan TF. 10-Hz Repetitive Transcranial Magnetic Stimulation of the Left Dorsolateral Prefrontal Cortex Reduces Heroin Cue Craving in Long-Term Addicts. Biol Psychiatry. 2016 Aug 1;80(3):e13-4. doi: 10.1016/j.biopsych.2016.02.006. Epub 2016 Feb 12. No abstract available.
Results Reference
background
PubMed Identifier
23709633
Citation
Herremans SC, Vanderhasselt MA, De Raedt R, Baeken C. Reduced intra-individual reaction time variability during a Go-NoGo task in detoxified alcohol-dependent patients after one right-sided dorsolateral prefrontal HF-rTMS session. Alcohol Alcohol. 2013 Sep-Oct;48(5):552-7. doi: 10.1093/alcalc/agt054. Epub 2013 May 24.
Results Reference
background

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Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence

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