NCT03470480

rTMS for Craving in Methamphetamine Use Disorder

Recruiting now NA Last updated 17 May 2024

What this trial tests

NA trial testing Real Repetitive transcranial magnetic stimulation in Methamphetamine Abuse in 50 participants. Currently enrolling.

Timeline

7 February 2018

Primary endpoint
1 September 2025

1 September 2025

Quick facts

Lead sponsor	Oregon Health and Science University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	50
Start date	7 February 2018
Primary completion	1 September 2025
Estimated completion	1 September 2025
Sites	1 location across United States

Drugs / interventions tested

• Real Repetitive transcranial magnetic stimulation
• Sham Repetitive transcranial magnetic stimulation
• Methamphetamine visual cues
• Neutral visual cues

Conditions studied

• Methamphetamine Abuse — all drugs for Methamphetamine Abuse →
• Substance Use Disorders — all drugs for Substance Use Disorders →
• Stimulant Dependence — all drugs for Stimulant Dependence →
• Methamphetamine-dependence — all drugs for Methamphetamine-dependence →

Sponsor

Oregon Health and Science University

Who can join

Adults 18 to 65, any sex, with Methamphetamine Abuse or Substance Use Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.