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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06244329
Enrollment
48
Registered
2024-02-06
Start date
2020-12-03
Completion date
2023-08-14
Last updated
2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

Keywords

Transcranial Magnetic Stimulation, Substance Use Disorders, Craving

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.

Interventions

DEVICETranscranial 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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

A blinded assessor, who is not aware of the condition order, conducts all behavioral assessments.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CravingBaseline (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.

Secondary

MeasureTime frameDescription
Readiness for changeBaseline (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.
Drug ConsumptionBaseline (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.
Trail Making TestBaseline (before the phase I intervention)A test of speed of processing
Mazes test from The Neuropsychological Assessment Battery® (NAB®)Baseline (before the phase I intervention)Mazes test is used to measure reasoning and problem-solving.
The Depression Anxiety Stress Scale (DASS)-short formBaseline (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.
Continuous Performance Test-Identical Pairs (CPT-IP)Baseline (before the phase I intervention)A computer-administered measure of sustained attention

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026