Repetitive Transcranial Magnetic Stimulation in Drugs Addiction

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06244329
• Other study ID #: HSEARS20210602002
• Status: Completed
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: August 14, 2023

Study information

• Verified date: October 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

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