Substance Use DisordersNCT06244329
Repetitive Transcranial Magnetic Stimulation in Drugs Addiction
A study testing Transcranial magnetic stimulation in people with Substance Use Disorders, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study also aims to develop and apply a standard repetitive transcranial magnetic stimulation (rTMS) protocol on drug users. The investigators want to focus on the effects of rTMS on amphetamine and cocaine as they are the most commonly used types of illicit drugs in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Dec 2020to 14 Aug 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 60.
- Illicit drug users in the community (not in institutions).
- Uses either amphetamine (ice) and/or cocaine frequently (at least 4 times per week).
- Craving Visual Analogue Scale (VAS, 11-point from 0 - 10) score of at least 5 or above on either amphetamine or cocaine.
- Interest in participating in drug treatment or rehabilitation or have already engaged in such services offered by health or social services.
- Not engaged in pharmacological or physical treatment related to substance use disorders in past six months.
Who cannot join
- Have a history of seizures or a family history of epilepsy.
- Have severe mental disorders like bipolar disorder or psychosis.
- Have brain damage from illness or injury, such as a brain tumor, a stroke or a traumatic brain injury.
- Have any metal or implanted medical devices in the body.
- Have frequent or severe headaches.
- Pregnant or thinking of becoming pregnant.
- Had prior treatment with rTMS in the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Application of Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunct Therapy in Reduction of Craving and Consumption of Illicit Drugs
This study also aims to develop and apply a standard repetitive transcranial magnetic stimulation (rTMS) protocol on drug users. The investigators want to focus on the effects of rTMS on amphetamine and cocaine as they are the most commonly used types of illicit drugs in Hong Kong.
The primary research question is:
Read more
- To examine if rTMS can reduce craving and consumption of the most commonly used illicit drugs (amphetamine, cocaine) among people with drug use disorders in Hong Kong?
The secondary research questions are:
- What is the association between rTMS protocol (frequency, intensity) and drug craving and consumption?
- Would there be gains in executing functioning among participants who have received rTMS treatment?
- Would there be a reduction in depressive and anxiety symptoms among participants who have received rTMS treatment?
The investigators would use a cross-over design (figure 1) to investigate the effects of rTMS. The investigators would recruit participants through community drug rehabilitation and youth outreach services. Participants who meet the selection and exclusion criteria will be invited to join. Upon obtaining their written consent, the investigators would randomize participants to a treatment (rTMS) group and a sham stimulation (placebo) group. Upon completing the first phase (2 weeks), there would be a washout period of 2 weeks. The two groups will swap (treatment becomes sham, and vice-versa) and the second phase will proceed. A double-blinded procedure will be implemented. Outcome measures will be conducted at baseline, after Phase I, at the start of Phase II, and at the end of Phase II.
- Conditions
- Substance Use Disorders
- Being tested
- Transcranial magnetic stimulation
- Keywords
- Transcranial Magnetic Stimulation, Substance Use Disorders, Craving
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
Transcranial Magnetic Stimulation (TMS) uses magnetic fields to stimulate nerve cells in the brain. TMS uses a small electromagnetic coil controlled by a computer program to deliver short, powerful pulses of magnetic energy focused precisely on parts of the brain's pre-frontal cortex. High-frequency repetitive TMS can enhance the excitability of the stimulated region.
| Study group | Role | What they receive |
|---|---|---|
| High frequency repetitive transcranial magnetic stimulation | Experimental | 10 Hz rTMS is applied to the left dorsolateral prefrontal cortex (DLPFC). The individual DLPFC is located using the Beam F3 method. The stimulation intensity is 100% of the resting motor threshold of the left primary motor cortex. Each session of stimulation lasts for around 9 mins. We apply 6-session rTMS, with 2-3 times per week. Receives: Device: Transcranial magnetic stimulation |
| Sham repetitive transcranial magnetic stimulation | Experimental | Sham rTMS is applied to the left dorsolateral prefrontal cortex (DLPFC). The individual DLPFC is located using the Beam F3 method. The stimulation intensity is 20% of the resting motor threshold of the left primary motor cortex, which is deemed completely ineffective in modulating brain excitability. We apply 6-session sham rTMS, with 2-3 times per week. Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving
An 11-item Craving Experience Questionnaire (CEQ), a theory-based and concise assessment tool for measuring substance cravings, is utilized. Each item is rated on a scale of 0 to 10, resulting in a total score range of 0 to 110. A higher score indicates a higher level of craving.
Measured: Baseline (before the phase I intervention)
Craving
An 11-item Craving Experience Questionnaire (CEQ), a theory-based and concise assessment tool for measuring substance cravings, is utilized. Each item is rated on a scale of 0 to 10, resulting in a total score range of 0 to 110. A higher score indicates a higher level of craving.
Measured: 3-week post intervention (after 6-session of the phase I intervention)
Craving
An 11-item Craving Experience Questionnaire (CEQ), a theory-based and concise assessment tool for measuring substance cravings, is utilized. Each item is rated on a scale of 0 to 10, resulting in a total score range of 0 to 110. A higher score indicates a higher level of craving.
Measured: Baseline (before the phase II intervention)
Craving
An 11-item Craving Experience Questionnaire (CEQ), a theory-based and concise assessment tool for measuring substance cravings, is utilized. Each item is rated on a scale of 0 to 10, resulting in a total score range of 0 to 110. A higher score indicates a higher level of craving.
Measured: 3-week post intervention (after 6-session of the phase II intervention)
Secondary outcomes (24)
Readiness for change
The Contemplation Ladder which measures the motivation for change, is used. The motivation for change is rated on a scale of 0 (No thought about quitting. I cannot live without drugs) to 10 (I have changed my drug use and will never go back to the way I used drugs before), with a total score of 10. A higher score means a higher motivation for change.
Measured: Baseline (before the phase I intervention)
Readiness for change
The Contemplation Ladder which measures the motivation for change, is used. The motivation for change is rated on a scale of 0 (No thought about quitting. I cannot live without drugs) to 10 (I have changed my drug use and will never go back to the way I used drugs before), with a total score of 10. A higher score means a higher motivation for change.
Measured: 3-week post intervention (after 6-session of the phase I intervention)
Readiness for change
The Contemplation Ladder which measures the motivation for change, is used. The motivation for change is rated on a scale of 0 (No thought about quitting. I cannot live without drugs) to 10 (I have changed my drug use and will never go back to the way I used drugs before), with a total score of 10. A higher score means a higher motivation for change.
Measured: Baseline (before the phase II intervention)
Readiness for change
The Contemplation Ladder which measures the motivation for change, is used. The motivation for change is rated on a scale of 0 (No thought about quitting. I cannot live without drugs) to 10 (I have changed my drug use and will never go back to the way I used drugs before), with a total score of 10. A higher score means a higher motivation for change.
Measured: 3-week post intervention (after 6-session of the phase II intervention)
Drug Consumption
A self-report questionnaire Set 6 of Beat Drug Fund (BDF)-Hong Kong, which assesses drug use frequency in past two weeks, is used. The patients are required to indicate their usage of each type of drug by selecting one of the following options: Never used, Used occasionally, and Used regularly.
Measured: Baseline (before the phase I intervention)
Drug Consumption
A self-report questionnaire Set 6 of Beat Drug Fund (BDF)-Hong Kong, which assesses drug use frequency in past two weeks, is used. The patients are required to indicate their usage of each type of drug by selecting one of the following options: Never used, Used occasionally, and Used regularly.
Measured: 3-week post intervention (after 6-session of the phase I intervention)
Drug Consumption
A self-report questionnaire Set 6 of Beat Drug Fund (BDF)-Hong Kong, which assesses drug use frequency in past two weeks, is used. The patients are required to indicate their usage of each type of drug by selecting one of the following options: Never used, Used occasionally, and Used regularly.
Measured: Baseline (before the phase II intervention)
Drug Consumption
A self-report questionnaire Set 6 of Beat Drug Fund (BDF)-Hong Kong, which assesses drug use frequency in past two weeks, is used. The patients are required to indicate their usage of each type of drug by selecting one of the following options: Never used, Used occasionally, and Used regularly.
Measured: 3-week post intervention (after 6-session of the phase II intervention)
Trail Making Test
A test of speed of processing
Measured: Baseline (before the phase I intervention)
Trail Making Test
A test of speed of processing
Measured: 3-week post intervention (after 6-session of the phase I intervention)
Trail Making Test
A test of speed of processing
Measured: Baseline (before the phase II intervention)
Trail Making Test
A test of speed of processing
Measured: 3-week post intervention (after 6-session of the phase II intervention)
Continuous Performance Test-Identical Pairs (CPT-IP)
A computer-administered measure of sustained attention
Measured: Baseline (before the phase I intervention)
Continuous Performance Test-Identical Pairs (CPT-IP)
A computer-administered measure of sustained attention
Measured: 3-week post intervention (after 6-session of the phase I intervention)
Continuous Performance Test-Identical Pairs (CPT-IP)
A computer-administered measure of sustained attention
Measured: Baseline (before the phase II intervention)
Continuous Performance Test-Identical Pairs (CPT-IP)
A computer-administered measure of sustained attention
Measured: 3-week post intervention (after 6-session of the phase II intervention)
Mazes test from The Neuropsychological Assessment Battery® (NAB®)
Mazes test is used to measure reasoning and problem-solving.
Measured: Baseline (before the phase I intervention)
Mazes test from The Neuropsychological Assessment Battery® (NAB®)
Mazes test is used to measure reasoning and problem-solving.
Measured: 3-week post intervention (after 6-session of the phase I intervention)
Mazes test from The Neuropsychological Assessment Battery® (NAB®)
Mazes test is used to measure reasoning and problem-solving.
Measured: Baseline (before the phase II intervention)
Mazes test from The Neuropsychological Assessment Battery® (NAB®)
Mazes test is used to measure reasoning and problem-solving.
Measured: 3-week post intervention (after 6-session of the phase II intervention)
The Depression Anxiety Stress Scale (DASS)-short form
The anxiety and depression subscales (13 items) of DASS is used for monitoring the negative emotional states of the participants. The total score is 39 with a higher scores indicating a higher level of emotional problems.
Measured: Baseline (before the phase I intervention)
The Depression Anxiety Stress Scale (DASS)-short form
The anxiety and depression subscales (13 items) of DASS is used for monitoring the negative emotional states of the participants. The total score is 39 with a higher scores indicating a higher level of emotional problems.
Measured: 3-week post intervention (after 6-session of the phase I intervention)
The Depression Anxiety Stress Scale (DASS)-short form
The anxiety and depression subscales (13 items) of DASS is used for monitoring the negative emotional states of the participants. The total score is 39 with a higher scores indicating a higher level of emotional problems.
Measured: Baseline (before the phase II intervention)
The Depression Anxiety Stress Scale (DASS)-short form
The anxiety and depression subscales (13 items) of DASS is used for monitoring the negative emotional states of the participants. The total score is 39 with a higher scores indicating a higher level of emotional problems.
Measured: 3-week post intervention (after 6-session of the phase II intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start3 Dec 2020
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244329
- Sponsor's protocol ID
- HSEARS20210602002
- Status last verified
- Oct 2023
- First submitted
- 27 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunct Therapy in Reduction of Craving and Consumption of Illicit Drugs
- ClinicalTrials.gov ID
- NCT06244329
- Acronym / sponsor ID
- HSEARS20210602002
- Conditions
- Substance Use Disorders
- Keywords
- Transcranial Magnetic Stimulation, Substance Use Disorders, Craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 6 Feb 2024 (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.
This study also aims to develop and apply a standard repetitive transcranial magnetic stimulation (rTMS) protocol on drug users. The investigators want to focus on the effects of rTMS on amphetamine and cocaine as they are the most commonly used types of illicit drugs in Hong Kong.
The primary research question is:
- To examine if rTMS can reduce craving and consumption of the most commonly used illicit drugs (amphetamine, cocaine) among people with drug use disorders in Hong Kong?
The secondary research questions are:
- What is the association between rTMS protocol (frequency, intensity) and drug craving and consumption?
- Would there be gains in executing functioning among participants who have received rTMS treatment?
- Would there be a reduction in depressive and anxiety symptoms among participants who have received rTMS treatment?
The investigators would use a cross-over design (figure 1) to investigate the effects of rTMS. The investigators would recruit participants through community drug rehabilitation and youth outreach services. Participants who meet the selection and exclusion criteria will be invited to join. Upon obtaining their written consent, the investigators would randomize participants to a treatment (rTMS) group and a sham stimulation (placebo) group. Upon completing the first phase (2 weeks), there would be a washout period of 2 weeks. The two groups will swap (treatment becomes sham, and vice-versa) and the second phase will proceed. A double-blinded procedure will be implemented. Outcome measures will be conducted at baseline, after Phase I, at the start of Phase II, and at the end of Phase II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High frequency repetitive transcranial magnetic stimulation | Experimental | Device: Transcranial magnetic stimulation10 Hz rTMS is applied to the left dorsolateral prefrontal cortex (DLPFC). The individual DLPFC is located using the Beam F3 method. The stimulation intensity is 100% of the resting motor threshold of the left primary motor cortex. Each session of stimulation lasts for around 9 mins. We apply 6-session rTMS, with 2-3 times per week. |
| Sham repetitive transcranial magnetic stimulation | Experimental | Device: Transcranial magnetic stimulationSham rTMS is applied to the left dorsolateral prefrontal cortex (DLPFC). The individual DLPFC is located using the Beam F3 method. The stimulation intensity is 20% of the resting motor threshold of the left primary motor cortex, which is deemed completely ineffective in modulating brain excitability. We apply 6-session sham rTMS, with 2-3 times per week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18 to 60.
- Illicit drug users in the community (not in institutions).
- Uses either amphetamine (ice) and/or cocaine frequently (at least 4 times per week).
- Craving Visual Analogue Scale (VAS, 11-point from 0 - 10) score of at least 5 or above on either amphetamine or cocaine.
- Interest in participating in drug treatment or rehabilitation or have already engaged in such services offered by health or social services.
Key exclusion criteria (7 listed)
- Have a history of seizures or a family history of epilepsy.
- Have severe mental disorders like bipolar disorder or psychosis.
- Have brain damage from illness or injury, such as a brain tumor, a stroke or a traumatic brain injury.
- Have any metal or implanted medical devices in the body.
- Have frequent or severe headaches.
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 stimulationTranscranial Magnetic Stimulation (TMS) uses magnetic fields to stimulate nerve cells in the brain. TMS uses a small electromagnetic coil controlled by a computer program to deliver short, powerful pulses of magnetic energy focused precisely on parts of the brain's pre-frontal cortex. High-frequency repetitive TMS can enhance the excitability of the stimulated region. | Device | High frequency repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation |
Primary outcome
Craving
Time frame: Baseline (before the phase I intervention)
An 11-item Craving Experience Questionnaire (CEQ), a theory-based and concise assessment tool for measuring substance cravings, is utilized. Each item is rated on a scale of 0 to 10, resulting in a total score range of 0 to 110. A higher score indicates a higher level of craving.
Craving
Time frame: 3-week post intervention (after 6-session of the phase I intervention)
An 11-item Craving Experience Questionnaire (CEQ), a theory-based and concise assessment tool for measuring substance cravings, is utilized. Each item is rated on a scale of 0 to 10, resulting in a total score range of 0 to 110. A higher score indicates a higher level of craving.
Craving
Time frame: Baseline (before the phase II intervention)
An 11-item Craving Experience Questionnaire (CEQ), a theory-based and concise assessment tool for measuring substance cravings, is utilized. Each item is rated on a scale of 0 to 10, resulting in a total score range of 0 to 110. A higher score indicates a higher level of craving.
Craving
Time frame: 3-week post intervention (after 6-session of the phase II intervention)
An 11-item Craving Experience Questionnaire (CEQ), a theory-based and concise assessment tool for measuring substance cravings, is utilized. Each item is rated on a scale of 0 to 10, resulting in a total score range of 0 to 110. A higher score indicates a higher level of craving.
24 secondary outcomes
Readiness for change
Time frame: Baseline (before the phase I intervention)
Readiness for change
Time frame: 3-week post intervention (after 6-session of the phase I intervention)
Readiness for change
Time frame: Baseline (before the phase II intervention)
Readiness for change
Time frame: 3-week post intervention (after 6-session of the phase II intervention)
Drug Consumption
Time frame: Baseline (before the phase I intervention)
Drug Consumption
Time frame: 3-week post intervention (after 6-session of the phase I intervention)
Drug Consumption
Time frame: Baseline (before the phase II intervention)
Drug Consumption
Time frame: 3-week post intervention (after 6-session of the phase II intervention)
Trail Making Test
Time frame: Baseline (before the phase I intervention)
Trail Making Test
Time frame: 3-week post intervention (after 6-session of the phase I intervention)
Trail Making Test
Time frame: Baseline (before the phase II intervention)
Trail Making Test
Time frame: 3-week post intervention (after 6-session of the phase II intervention)
Continuous Performance Test-Identical Pairs (CPT-IP)
Time frame: Baseline (before the phase I intervention)
Continuous Performance Test-Identical Pairs (CPT-IP)
Time frame: 3-week post intervention (after 6-session of the phase I intervention)
Continuous Performance Test-Identical Pairs (CPT-IP)
Time frame: Baseline (before the phase II intervention)
Continuous Performance Test-Identical Pairs (CPT-IP)
Time frame: 3-week post intervention (after 6-session of the phase II intervention)
Mazes test from The Neuropsychological Assessment Battery® (NAB®)
Time frame: Baseline (before the phase I intervention)
Mazes test from The Neuropsychological Assessment Battery® (NAB®)
Time frame: 3-week post intervention (after 6-session of the phase I intervention)
Mazes test from The Neuropsychological Assessment Battery® (NAB®)
Time frame: Baseline (before the phase II intervention)
Mazes test from The Neuropsychological Assessment Battery® (NAB®)
Time frame: 3-week post intervention (after 6-session of the phase II intervention)
The Depression Anxiety Stress Scale (DASS)-short form
Time frame: Baseline (before the phase I intervention)
The Depression Anxiety Stress Scale (DASS)-short form
Time frame: 3-week post intervention (after 6-session of the phase I intervention)
The Depression Anxiety Stress Scale (DASS)-short form
Time frame: Baseline (before the phase II intervention)
The Depression Anxiety Stress Scale (DASS)-short form
Time frame: 3-week post intervention (after 6-session of the phase II intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Substance Use Disorders, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 6 Feb 2024. 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 Hong Kong. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving (time frame: Baseline (before the phase I intervention)). 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?
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 6 Feb 2024.