Heroin DependenceTHEDNCT03922659
Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence
A study testing Transcranial magnetic stimulation and Cognitive behavioral therapy in people with Heroin Dependence, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heroin Dependence
- What is being tested?
- Transcranial magnetic stimulation and Cognitive behavioral therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
About this study
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.
- Conditions
- Heroin Dependence
- Being tested
- Transcranial magnetic stimulation and Cognitive behavioral therapy
- Keywords
- Heroin dependence, transcranial magnetic stimulation, cognitive behavioral therapy
- Medical subject headings
- Heroin Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation and Cognitive behavioral therapyCombination product
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Regular treatment (symptomatic treatment) with blank TMS | Placebo comparator | Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation Receives: Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy |
| Regular treatment (RT) with blank TMS and CBT | Active comparator | Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy Receives: Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy |
| RT with right DLPFC hf-rTMS | Active comparator | Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS) Receives: Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy |
| RT with right DLPFC hf-rTMS and CBT | Active comparator | Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT) Receives: Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy |
| RT with left DLPFC hf-rTMS | Active comparator | Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) Receives: Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy |
| RT with left DLPFC hf-rTMS and CBT | Active comparator | Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT) Receives: Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Measured: 1 month
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Measured: 2 month
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Measured: 3 month
Recurrence of heroin dependence
The rate of relapse of heroin dependence after discharge from hospital
Measured: 6 month
Secondary outcomes (8)
Duration of abstinence
The total time or period without any intake of heroin during follow-ups
Measured: 6 months
Heroin consumption
Diaries of heroin intake in different time of the follow-ups
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks, 1 month, 2 months, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start30 Jun 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Peng, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922659
- Sponsor's protocol ID
- 2019-12-TMSCBT-H
- Acronym
- THED
- Status last verified
- Mar 2021
- First submitted
- 17 Apr 2019
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19524780Makani 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.
PubMed 29189190Shen 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.
PubMed 26995024Herremans 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.
PubMed 23709633
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Heroin Dependence
- ClinicalTrials.gov ID
- NCT03922659
- Acronym / sponsor ID
- THED / 2019-12-TMSCBT-H
- Conditions
- Heroin Dependence
- Keywords
- Heroin dependence, transcranial magnetic stimulation, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Regular treatment (symptomatic treatment) with blank TMS | Placebo comparator | Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapyRegular treatment (symptomatic treatment) with blank transcranial magnetic stimulation |
| Regular treatment (RT) with blank TMS and CBT | Active comparator | Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapyRegular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy |
| RT with right DLPFC hf-rTMS | Active comparator | Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapyRegular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS) |
| RT with right DLPFC hf-rTMS and CBT | Active comparator | Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapyRegular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT) |
| RT with left DLPFC hf-rTMS | Active comparator | Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapyRegular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) |
| RT with left DLPFC hf-rTMS and CBT | Active comparator | Combination Product: Transcranial magnetic stimulation and Cognitive behavioral therapyRegular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulation and Cognitive behavioral therapyTranscranial magnetic stimulation on different side with/without cognitive behavioral therapy | Combination product | RT with left DLPFC hf-rTMS, RT with left DLPFC hf-rTMS and CBT, RT with right DLPFC hf-rTMS, RT with right DLPFC hf-rTMS and CBT, Regular treatment (RT) with blank TMS and CBT, Regular treatment (symptomatic treatment) with blank TMS |
Primary outcome
Recurrence of heroin dependence
Time frame: 1 month
The rate of relapse of heroin dependence after discharge from hospital
Recurrence of heroin dependence
Time frame: 2 month
The rate of relapse of heroin dependence after discharge from hospital
Recurrence of heroin dependence
Time frame: 3 month
The rate of relapse of heroin dependence after discharge from hospital
Recurrence of heroin dependence
Time frame: 6 month
The rate of relapse of heroin dependence after discharge from hospital
8 secondary outcomes
Duration of abstinence
Time frame: 6 months
Heroin consumption
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Craving for heroin
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Craving for heroin
Time frame: 2weeks, 1 month, 2 months, 3 months and 6 months
Cognitive assessment
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Psychological assessment - Anxiety
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Psychological assessment - Depression
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Psychological assessment - Sleep
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Background: PubMed 19524780Phillips 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.
- Background: PubMed 29189190Makani 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.
- Background: PubMed 26995024Shen 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.
- Background: PubMed 23709633Herremans 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation and Cognitive behavioral therapy in people with Heroin Dependence, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Peng, MD, PhD (+86-13380051581, pengy2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of heroin dependence (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03922659, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.