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

Heroin Dependence Clinical Trial

— THED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03922659
• Other study ID #: 2019-12-TMSCBT-H
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2019
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Ying Peng, MD, PhD
• Phone: +86-13380051581
• Email: pengy2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Heroin Dependence

Intervention

Combination Product:
• Transcranial magnetic stimulation and Cognitive behavioral therapy
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of heroin dependence	The rate of relapse of heroin dependence after discharge from hospital	1 month
Primary	Recurrence of heroin dependence	The rate of relapse of heroin dependence after discharge from hospital	2 month
Primary	Recurrence of heroin dependence	The rate of relapse of heroin dependence after discharge from hospital	3 month
Primary	Recurrence of heroin dependence	The rate of relapse of heroin dependence after discharge from hospital	6 month
Secondary	Duration of abstinence	The total time or period without any intake of heroin during follow-ups	6 months
Secondary	Heroin consumption	Diaries of heroin intake in different time of the follow-ups	2 weeks, 1 month, 2 months, 3 months and 6 months
Secondary	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.	2 weeks, 1 month, 2 months, 3 months and 6 months
Secondary	Craving for heroin	Craving assessment by Visual Analogue Scale (VAS) for heroin desire ranging 0 to 10. Higher score indicates more desire for heroin.	2weeks, 1 month, 2 months, 3 months and 6 months
Secondary	Cognitive assessment	Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.	2 weeks, 1 month, 2 months, 3 months and 6 months
Secondary	Psychological assessment - Anxiety	Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.	2 weeks, 1 month, 2 months, 3 months and 6 months
Secondary	Psychological assessment - Depression	Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.	2 weeks, 1 month, 2 months, 3 months and 6 months
Secondary	Psychological assessment - Sleep	Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.	2 weeks, 1 month, 2 months, 3 months and 6 months