An interventional study of Transcranial magnetic stimulation and Cognitive behavioral therapy in Heroin Dependence, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-22.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's planned enrollment of 300 is above the median of 87 across 57 interventional studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS)
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Time frame: 1 month
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Time frame: 2 month
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Time frame: 3 month
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Time frame: 6 month
Duration of abstinence
The total time or period without any intake of heroin during follow-ups
Time frame: 6 months
Heroin consumption
Diaries of heroin intake in different time of the follow-ups
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
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.
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Craving for heroin
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
Cognitive assessment
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
Psychological assessment - Anxiety
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
Psychological assessment - Depression
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
Psychological assessment - Sleep
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
Plan to share: No
Started Jun 2019 (actual). Primary completion is estimated for Dec 2021, 30 months after the start.
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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University →