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

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 Overview

• Status: Completed
• Conditions: Substance Use Disorders
• Intervention / Treatment: Device: Transcranial magnetic stimulation

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 to 60.
2. Illicit drug users in the community (not in institutions).
3. Uses either amphetamine (ice) and/or cocaine frequently (at least 4 times per week).
4. Craving Visual Analogue Scale (VAS, 11-point from 0 - 10) score of at least 5 or above on either amphetamine or cocaine.
5. Interest in participating in drug treatment or rehabilitation or have already engaged in such services offered by health or social services.
6. Not engaged in pharmacological or physical treatment related to substance use disorders in past six months.

Exclusion Criteria:

1. Have a history of seizures or a family history of epilepsy.
2. Have severe mental disorders like bipolar disorder or psychosis.
3. Have brain damage from illness or injury, such as a brain tumor, a stroke or a traumatic brain injury.
4. Have any metal or implanted medical devices in the body.
5. Have frequent or severe headaches.
6. Pregnant or thinking of becoming pregnant.
7. Had prior treatment with rTMS in the past year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High frequency repetitive transcranial magnetic stimulation; 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.	Device: Transcranial magnetic stimulation; 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.
Experimental: Sham repetitive transcranial magnetic stimulation; 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.	Device: Transcranial magnetic stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	3-week post intervention (after 6-session of the phase II intervention)
Trail Making Test	A test of speed of processing	Baseline (before the phase I intervention)
Trail Making Test	A test of speed of processing	3-week post intervention (after 6-session of the phase I intervention)
Trail Making Test	A test of speed of processing	Baseline (before the phase II intervention)
Trail Making Test	A test of speed of processing	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	Baseline (before the phase I intervention)
Continuous Performance Test-Identical Pairs (CPT-IP)	A computer-administered measure of sustained attention	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	Baseline (before the phase II intervention)
Continuous Performance Test-Identical Pairs (CPT-IP)	A computer-administered measure of sustained attention	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.	Baseline (before the phase I intervention)
Mazes test from The Neuropsychological Assessment Battery® (NAB®)	Mazes test is used to measure reasoning and problem-solving.	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.	Baseline (before the phase II intervention)
Mazes test from The Neuropsychological Assessment Battery® (NAB®)	Mazes test is used to measure reasoning and problem-solving.	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.	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.	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.	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.	3-week post intervention (after 6-session of the phase II intervention)

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: January 27, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation; Craving; Substance Use Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: HSEARS20210602002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No