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Completed

NCT Number: NCT06244329

Repetitive Transcranial Magnetic Stimulation in Drugs Addiction

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.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Readiness for change

    Time frame: Baseline (before the phase I intervention)

    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.

  2. Readiness for change

    Time frame: 3-week post intervention (after 6-session of the phase I intervention)

    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.

  3. Readiness for change

    Time frame: Baseline (before the phase II intervention)

    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.

  4. Readiness for change

    Time frame: 3-week post intervention (after 6-session of the phase II intervention)

    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.

  5. Drug Consumption

    Time frame: Baseline (before the phase I intervention)

    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.

  6. Drug Consumption

    Time frame: 3-week post intervention (after 6-session of the phase I intervention)

    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.

  7. Drug Consumption

    Time frame: Baseline (before the phase II intervention)

    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.

  8. Drug Consumption

    Time frame: 3-week post intervention (after 6-session of the phase II intervention)

    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.

  9. Trail Making Test

    Time frame: Baseline (before the phase I intervention)

    A test of speed of processing

  10. Trail Making Test

    Time frame: 3-week post intervention (after 6-session of the phase I intervention)

    A test of speed of processing

  11. Trail Making Test

    Time frame: Baseline (before the phase II intervention)

    A test of speed of processing

  12. Trail Making Test

    Time frame: 3-week post intervention (after 6-session of the phase II intervention)

    A test of speed of processing

  13. Continuous Performance Test-Identical Pairs (CPT-IP)

    Time frame: Baseline (before the phase I intervention)

    A computer-administered measure of sustained attention

  14. Continuous Performance Test-Identical Pairs (CPT-IP)

    Time frame: 3-week post intervention (after 6-session of the phase I intervention)

    A computer-administered measure of sustained attention

  15. Continuous Performance Test-Identical Pairs (CPT-IP)

    Time frame: Baseline (before the phase II intervention)

    A computer-administered measure of sustained attention

  16. Continuous Performance Test-Identical Pairs (CPT-IP)

    Time frame: 3-week post intervention (after 6-session of the phase II intervention)

    A computer-administered measure of sustained attention

  17. Mazes test from The Neuropsychological Assessment Battery® (NAB®)

    Time frame: Baseline (before the phase I intervention)

    Mazes test is used to measure reasoning and problem-solving.

  18. Mazes test from The Neuropsychological Assessment Battery® (NAB®)

    Time frame: 3-week post intervention (after 6-session of the phase I intervention)

    Mazes test is used to measure reasoning and problem-solving.

  19. Mazes test from The Neuropsychological Assessment Battery® (NAB®)

    Time frame: Baseline (before the phase II intervention)

    Mazes test is used to measure reasoning and problem-solving.

  20. Mazes test from The Neuropsychological Assessment Battery® (NAB®)

    Time frame: 3-week post intervention (after 6-session of the phase II intervention)

    Mazes test is used to measure reasoning and problem-solving.

  21. The Depression Anxiety Stress Scale (DASS)-short form

    Time frame: Baseline (before the phase I intervention)

    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.

  22. The Depression Anxiety Stress Scale (DASS)-short form

    Time frame: 3-week post intervention (after 6-session of the phase I intervention)

    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.

  23. The Depression Anxiety Stress Scale (DASS)-short form

    Time frame: Baseline (before the phase II intervention)

    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.

  24. The Depression Anxiety Stress Scale (DASS)-short form

    Time frame: 3-week post intervention (after 6-session of the phase II intervention)

    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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

The Application of Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunct Therapy in Reduction of Craving and Consumption of Illicit Drugs

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2024
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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