What this study is
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.
What's being tested
- Real Repetitive transcranial magnetic stimulation
Intervention · 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.
- Sham Repetitive transcranial magnetic stimulation
Intervention · 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 · BEHAVIORAL
Just before each rTMS session, participants will be shown methamphetamine-related pictures
- Neutral visual cues
Intervention · BEHAVIORAL
Just before each rTMS session, participants will be shown neutral pictures
Study details
- Official title
- The Use of Repetitive Transmagnetic Stimulation to Target Craving in Methamphetamine Use Disorder
- Sponsor
- Oregon Health and Science University
- Conditions
- Methamphetamine Abuse · Substance Use Disorders · Stimulant Dependence · Methamphetamine-dependence · Stimulant Use · Transcranial Magnetic Stimulation
- Enrolling
- 50 people
- Starts
- 2018-02-07
- Est. completion
- 2027-09-01
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVeterans Affairs Portland Health Care System
Portland, Oregon, United States
- Brandon J Cornejo, MD, PhD · Contact503-721-7964
- Holly McCready · Contact503-721-7964
- Brandon J Cornejo, MD, PhD · Principal investigator
Recruiting
Study team
Sponsor
Oregon Health and Science University
Study ID GPSYC0236A
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.