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

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Sun Yat-sen University

Status

Unknown

Conditions

Heroin Dependence

Treatments

Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03922659
2019-12-TMSCBT-H

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Triple Blind

300 participants in 6 patient groups, including a placebo group

Regular treatment (symptomatic treatment) with blank TMS
Placebo Comparator group
Description:
Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation
Treatment:
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
Regular treatment (RT) with blank TMS and CBT
Active Comparator group
Description:
Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy
Treatment:
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
RT with right DLPFC hf-rTMS
Active Comparator group
Description:
Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
Treatment:
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
RT with right DLPFC hf-rTMS and CBT
Active Comparator group
Description:
Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
Treatment:
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
RT with left DLPFC hf-rTMS
Active Comparator group
Description:
Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
Treatment:
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
RT with left DLPFC hf-rTMS and CBT
Active Comparator group
Description:
Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
Treatment:
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy

Trial contacts and locations

1

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Central trial contact

Ying Peng, MD, PhD; Hongxuan Wang, MD, PhD

Data sourced from clinicaltrials.gov

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