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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

300

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

April 17, 2019

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed

2 months until next milestone

Study Start

First participant enrolled

June 30, 2019

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed

Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

2.4 years

First QC Date

April 17, 2019

Last Update Submit

March 19, 2021

Conditions

Heroin Dependence

Keywords

Heroin dependence, transcranial magnetic stimulation, cognitive behavioral therapy

Outcome Measures

Primary Outcomes (4)

Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
1 month
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
2 month
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
3 month
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
6 month

Secondary Outcomes (8)

Duration of abstinence
6 months
Heroin consumption
2 weeks, 1 month, 2 months, 3 months and 6 months
Craving for heroin
2 weeks, 1 month, 2 months, 3 months and 6 months
Craving for heroin
2weeks, 1 month, 2 months, 3 months and 6 months
Cognitive assessment
2 weeks, 1 month, 2 months, 3 months and 6 months
+3 more secondary outcomes