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Clinical Trials/NCT03922659
NCT03922659UnknownNot Applicable

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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 site in 1 country300 target enrollmentStarted: June 30, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
1
Primary Endpoint
Recurrence of heroin dependence

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Regular treatment (symptomatic treatment) with blank TMS

Placebo Comparator

Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation

Intervention: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)

Regular treatment (RT) with blank TMS and CBT

Active Comparator

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

Intervention: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)

RT with right DLPFC hf-rTMS and CBT

Active Comparator

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

Intervention: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)

RT with left DLPFC hf-rTMS

Active Comparator

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

Intervention: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)

RT with left DLPFC hf-rTMS and CBT

Active Comparator

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

Intervention: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)

RT with right DLPFC hf-rTMS

Active Comparator

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

Intervention: Transcranial magnetic stimulation and Cognitive behavioral therapy (Combination Product)

Outcomes

Primary Outcomes

Recurrence of heroin dependence

Time Frame: 6 month

The rate of relapse of heroin dependence after discharge from hospital

Recurrence of heroin dependence

Time Frame: 3 month

The rate of relapse of heroin dependence after discharge from hospital

Recurrence of heroin dependence

Time Frame: 1 month

The rate of relapse of heroin dependence after discharge from hospital

Recurrence of heroin dependence

Time Frame: 2 month

The rate of relapse of heroin dependence after discharge from hospital

Secondary Outcomes

  • Duration of abstinence(6 months)
  • Heroin consumption(2 weeks, 1 month, 2 months, 3 months and 6 months)
  • Craving for heroin(2weeks, 1 month, 2 months, 3 months and 6 months)
  • Cognitive assessment(2 weeks, 1 month, 2 months, 3 months and 6 months)
  • Psychological assessment - Anxiety(2 weeks, 1 month, 2 months, 3 months and 6 months)
  • Psychological assessment - Depression(2 weeks, 1 month, 2 months, 3 months and 6 months)
  • Psychological assessment - Sleep(2 weeks, 1 month, 2 months, 3 months and 6 months)
  • Craving for heroin(2 weeks, 1 month, 2 months, 3 months and 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ying Peng

Professor, Director of Department of Neurology

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Sites (1)

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