Clinical trial NCT06244329: Repetitive Transcranial Magnetic Stimulation in Drugs Addiction
Official title: The Application of Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunct Therapy in Reduction of Craving and Consumption of Illicit Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Transcranial Magnetic Stimulation
Substance Use Disorders
Craving
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Craving
timeFrame: Baseline (before the phase I intervention)
measure: Craving
timeFrame: 3-week post intervention (after 6-session of the phase I intervention)
measure: Craving
timeFrame: Baseline (before the phase II intervention)
measure: Craving
timeFrame: 3-week post intervention (after 6-session of the phase II intervention)
Secondary outcomes:
measure: Readiness for change
timeFrame: Baseline (before the phase I intervention)
measure: Readiness for change
timeFrame: 3-week post intervention (after 6-session of the phase I intervention)
measure: Readiness for change
timeFrame: Baseline (before the phase II intervention)
measure: Readiness for change
timeFrame: 3-week post intervention (after 6-session of the phase II intervention)
measure: Drug Consumption
timeFrame: Baseline (before the phase I intervention)
measure: Drug Consumption
timeFrame: 3-week post intervention (after 6-session of the phase I intervention)
measure: Drug Consumption
timeFrame: Baseline (before the phase II intervention)
measure: Drug Consumption
timeFrame: 3-week post intervention (after 6-session of the phase II intervention)
measure: Trail Making Test
timeFrame: Baseline (before the phase I intervention)
measure: Trail Making Test
timeFrame: 3-week post intervention (after 6-session of the phase I intervention)
measure: Trail Making Test
timeFrame: Baseline (before the phase II intervention)
measure: Trail Making Test
timeFrame: 3-week post intervention (after 6-session of the phase II intervention)
measure: Continuous Performance Test-Identical Pairs (CPT-IP)
timeFrame: Baseline (before the phase I intervention)
measure: Continuous Performance Test-Identical Pairs (CPT-IP)
timeFrame: 3-week post intervention (after 6-session of the phase I intervention)
measure: Continuous Performance Test-Identical Pairs (CPT-IP)
timeFrame: Baseline (before the phase II intervention)
measure: Continuous Performance Test-Identical Pairs (CPT-IP)
timeFrame: 3-week post intervention (after 6-session of the phase II intervention)
measure: Mazes test from The Neuropsychological Assessment Battery® (NAB®)
timeFrame: Baseline (before the phase I intervention)
measure: Mazes test from The Neuropsychological Assessment Battery® (NAB®)
timeFrame: 3-week post intervention (after 6-session of the phase I intervention)
measure: Mazes test from The Neuropsychological Assessment Battery® (NAB®)
timeFrame: Baseline (before the phase II intervention)
measure: Mazes test from The Neuropsychological Assessment Battery® (NAB®)
timeFrame: 3-week post intervention (after 6-session of the phase II intervention)
measure: The Depression Anxiety Stress Scale (DASS)-short form
timeFrame: Baseline (before the phase I intervention)
measure: The Depression Anxiety Stress Scale (DASS)-short form
timeFrame: 3-week post intervention (after 6-session of the phase I intervention)
measure: The Depression Anxiety Stress Scale (DASS)-short form
timeFrame: Baseline (before the phase II intervention)
measure: The Depression Anxiety Stress Scale (DASS)-short form
timeFrame: 3-week post intervention (after 6-session of the phase II intervention)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: