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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGRecurrence 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
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