Repetitive Transcranial Magnetic Stimulation in Drugs Addiction
The Application of Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunct Therapy in Reduction of Craving and Consumption of Illicit Drugs
1 other identifier
interventional
48
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2023
CompletedFirst Submitted
Initial submission to the registry
January 27, 2024
CompletedFirst Posted
Study publicly available on registry
February 6, 2024
CompletedFebruary 6, 2024
October 1, 2023
2.7 years
January 27, 2024
February 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
3-week post intervention (after 6-session of the phase II intervention)
Secondary Outcomes (24)
Readiness for change
Baseline (before the phase I intervention)
Readiness for change
3-week post intervention (after 6-session of the phase I intervention)
Readiness for change
Baseline (before the phase II intervention)
Readiness for change
3-week post intervention (after 6-session of the phase II intervention)
Drug Consumption
Baseline (before the phase I intervention)
- +19 more secondary outcomes
Study Arms (2)
High frequency repetitive transcranial magnetic stimulation
EXPERIMENTAL10 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
EXPERIMENTALSham 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- A blinded assessor, who is not aware of the condition order, conducts all behavioral assessments.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2024
First Posted
February 6, 2024
Study Start
December 3, 2020
Primary Completion
August 14, 2023
Study Completion
August 14, 2023
Last Updated
February 6, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share