rTMS for Craving in Methamphetamine Use Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-07

Study Completion Date

2025-09-01

Brief Summary

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The primary aim of this project is to use a randomized single-blind sham-controlled study to investigate if high frequency repetitive transmagnetic stimulation (HF-rTMS) can modulate cue-induced craving in adult methamphetamine (METH) users. The investigators hypothesize that HF-rTMS directed at left dorsolateral prefrontal cortex (DLPFC) will result in a reduction in craving for METH compared to sham-controlled rTMS in adults with methamphetamine use disorder (MUD) as evidenced by validated measures of METH craving. Neurobiologically, the investigators anticipate rTMS mediated stimulation of the DLPFC could result in inhibition of cue-induced craving through potential disruption of involved circuitry. The current project proposes that participants who are recently abstinent from METH will be randomized into four experimental groups to provide two rTMS conditions (real versus sham) and two picture cues conditions (METH versus neutral). The experiment will have an induction phase where each subject will receive 10 daily treatments within 2 weeks. Just before each rTMS/sham session participants will be shown visual cues (METH or neutral). Participants will then undergo a maintenance phase for an additional month with assessments to evaluate craving and relapse. Urine samples for urine drug screening (UDS) will be collected at screening day and on days 1, 5 and 10. Just before each rTMS/sham session participants will be shown visual cues (METH and neutral). VAS craving scores will be assessed before and after picture presentation and after the rTMS/sham session. Before the first and 10th treatment session, participants were evaluated by the the Stimulant Craving Questionnaire (STCQ) and the Severity of Dependence Scale (SDS) questionnaires. Participants will then undergo a maintenance phase for an additional month. During the first week of maintenance, three rTMS/sham sessions will be administered. During each of the following 3 weeks, one rTMS/sham session will be given per week. As with the induction phase, urine samples will be collected for screening and STCQ and the SDS questionnaires will be completed at each maintenance session. To evaluate the long-term effects of the rTMS treatment, the investigators plan on contacting participants 6 months after treatment termination for all subjects who completed the 10 treatment sessions. During that phone conversation, craving and relapse will again be assessed.

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Detailed Description

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Conditions

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Methamphetamine Abuse Substance Use Disorders Stimulant Dependence Methamphetamine-dependence Stimulant Use Transcranial Magnetic Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This preliminary study aims to consent and enroll 20 individuals with Methamphetamine Use Disorder. Participants will be randomized into two rTMS conditions (real versus sham) and two picture cues conditions (METH versus neutral). Randomization provides the following four groups: real METH (RM), real neutral (RN), sham METH (SM) and sham neutral (SN). The randomizations can be performed with a web-based randomization generator (www.randomization.com) (47). Subjects and rTMS administrators will be blinded to the treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment rTMS + meth pictures

Participants in this group will receive real repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of methamphetamine-related pictures to evaluate response to methamphetamine visual cues while receiving real rTMS treatments. This group will be referred to as real METH (RM).

Group Type EXPERIMENTAL

Real Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

A real magnet will be used during rTMS treatments, which will look identical to the sham magnet. The participants and treatment facilitator will be blinded to which magnet will be used. High frequency repetitive transmagnetic stimulation (rTMS) will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month.

Methamphetamine visual cues

Intervention Type BEHAVIORAL

Just before each rTMS session, participants will be shown methamphetamine-related pictures

Treatment rTMS + neutral pictures

Participants in this group will receive real repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of neutral pictures to evaluate response to neutral visual cues while receiving real rTMS treatments. This group will be referred to as real neutral (RN).

Group Type ACTIVE_COMPARATOR

Real Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

A real magnet will be used during rTMS treatments, which will look identical to the sham magnet. The participants and treatment facilitator will be blinded to which magnet will be used. High frequency repetitive transmagnetic stimulation (rTMS) will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month.

Neutral visual cues

Intervention Type BEHAVIORAL

Just before each rTMS session, participants will be shown neutral pictures

Sham rTMS + meth pictures

Participants in this group will receive sham repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of methamphetamine-related pictures to evaluate response to methamphetamine visual cues while receiving sham rTMS treatments. This group will be referred to as sham METH (SM).

Group Type SHAM_COMPARATOR

Sham Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

A sham magnet will be used during rTMS treatments, which will look identical to the real magnet. The participants and treatment facilitator will be blinded to which magnet will be used. The sham rTMS treatments will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month.

Methamphetamine visual cues

Intervention Type BEHAVIORAL

Just before each rTMS session, participants will be shown methamphetamine-related pictures

Sham rTMS + neutral pictures

Participants in this group will receive sham repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of neutral pictures to evaluate response to neutral visual cues while receiving sham rTMS treatments. This group will be referred to as sham neutral (SN).

Group Type SHAM_COMPARATOR

Sham Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

A sham magnet will be used during rTMS treatments, which will look identical to the real magnet. The participants and treatment facilitator will be blinded to which magnet will be used. The sham rTMS treatments will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month.

Neutral visual cues

Intervention Type BEHAVIORAL

Just before each rTMS session, participants will be shown neutral pictures

Interventions

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Real Repetitive transcranial magnetic stimulation

A real magnet will be used during rTMS treatments, which will look identical to the sham magnet. The participants and treatment facilitator will be blinded to which magnet will be used. High frequency repetitive transmagnetic stimulation (rTMS) will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month.

Intervention Type DEVICE

Sham Repetitive transcranial magnetic stimulation

A sham magnet will be used during rTMS treatments, which will look identical to the real magnet. The participants and treatment facilitator will be blinded to which magnet will be used. The sham rTMS treatments will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month.

Intervention Type DEVICE

Methamphetamine visual cues

Just before each rTMS session, participants will be shown methamphetamine-related pictures

Intervention Type BEHAVIORAL

Neutral visual cues

Just before each rTMS session, participants will be shown neutral pictures

Intervention Type BEHAVIORAL

Other Intervention Names

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rTMS TMS Magstim Rapid 2

Eligibility Criteria

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Inclusion Criteria

* Subjects must use at least 0.5 g per day at least 5 days per week and have a minimum 12-month history of METH abuse.
* Subjects must meet DSM V diagnosis for methamphetamine use disorder.
* Subjects must have a minimum 4-week period of detoxification and a desire to stop using methamphetamine.

Exclusion Criteria

* Present or past history of neurological disorder
* The present history of a DSM IV Axis I or DSM V primary psychiatric disease (apart from MUD and depressive symptoms defined as a Hamilton Depression Scale Score \< 7 ("normal"))
* Scores on the Hamilton Depression Scale \> 8, possibly indicating clinical depression
* No current abuse of drugs other than methamphetamine (except nicotine). Urine-screening tests for psychoactive drugs will be performed to corroborate the lack of drug use.
* Individuals meeting criteria for cannabis use disorder or alcohol use disorder
* Medical illness that can affect brain function
* Past or present history of cardiovascular disease or high blood pressure
* Any history of epilepsy or a known history of seizure disorder
* A history of metal in the head or chest area (except dental fillings or braces)
* Current consumption of psychiatric medication
* Any other medical, neurological or neurosurgical condition that would preclude the administration of repetitive transmagnetic stimulation

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No