Recruiting

rTMS

Sponsor:

Oregon Health and Science University

Code:

NCT03470480

Conditions

Methamphetamine Abuse

Substance Use Disorders

Stimulant Dependence

Methamphetamine-dependence

Stimulant Use

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Real Repetitive transcranial magnetic stimulation

Sham Repetitive transcranial magnetic stimulation

Methamphetamine visual cues

Neutral visual cues

Study Details

Brief summary:

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.

Conditions

Methamphetamine Abuse

Substance Use Disorders

Stimulant Dependence

Methamphetamine-dependence

Stimulant Use

Study ID

NCT03470480

Start date

Feb 7, 2018

Status verified date

May, 2024

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

active comparator: 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).

sham comparator: 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).

sham comparator: 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).

Interventions

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.

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.

Methamphetamine visual cues

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

Neutral visual cues

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

Primary outcome measure

  • Effect of rTMS directed at left DLPFC on craving for methamphetamine as assessed by the Severity of Dependence Scale. [ Time Frame: 6 weeks ]
  • Effect of rTMS directed at left DLPFC on craving for methamphetamine as assessed by a Visual Analog Scale (VAS). [ Time Frame: 6 weeks ]
  • Effect of rTMS directed at left DLPFC on craving for methamphetamine as assessed by the Stimulant Craving Questionnaire (STCQ). [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Brandon J Cornejo, MD, PhD

503-721-7964brandon.cornejo@va.gov

Holly McCready

503-721-7964

Locations

Veterans Affairs Portland Health Care System

Recruiting

Portland, Oregon, United States, 97239

Contacts

Brandon J Cornejo, MD, PhD

503-721-7964

Holly McCready

503-721-7964

Principal Investigator:

Brandon J Cornejo, MD, PhD

More Information

Sponsor

Oregon Health and Science University

Last update posted

May 17, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-05-17.