Clinical trial NCT03922659: Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence
Official title: Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heroin Dependence
Keywords: Heroin dependence, transcranial magnetic stimulation, cognitive behavioral therapy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recurrence of heroin dependence
timeFrame: 1 month
measure: Recurrence of heroin dependence
timeFrame: 2 month
measure: Recurrence of heroin dependence
timeFrame: 3 month
measure: Recurrence of heroin dependence
timeFrame: 6 month
Secondary outcomes:
measure: Duration of abstinence
timeFrame: 6 months
measure: Heroin consumption
timeFrame: 2 weeks, 1 month, 2 months, 3 months and 6 months
measure: Craving for heroin
timeFrame: 2 weeks, 1 month, 2 months, 3 months and 6 months
measure: Craving for heroin
timeFrame: 2weeks, 1 month, 2 months, 3 months and 6 months
measure: Cognitive assessment
timeFrame: 2 weeks, 1 month, 2 months, 3 months and 6 months
measure: Psychological assessment - Anxiety
timeFrame: 2 weeks, 1 month, 2 months, 3 months and 6 months
measure: Psychological assessment - Depression
timeFrame: 2 weeks, 1 month, 2 months, 3 months and 6 months
measure: Psychological assessment - Sleep
timeFrame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
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.
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.
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.
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.