RECRUITING

rTMS for Craving in Methamphetamine Use Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Use of Repetitive Transmagnetic Stimulation to Target Craving in Methamphetamine Use Disorder

Quick Facts

Study Start:2018-02-07
Study Completion:2025-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03470480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Subjects must meet DSM V diagnosis for methamphetamine use disorder.
  3. * Subjects must have a minimum 4-week period of detoxification and a desire to stop using methamphetamine.
  1. * Present or past history of neurological disorder
  2. * 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"))
  3. * Scores on the Hamilton Depression Scale \> 8, possibly indicating clinical depression
  4. * 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.
  5. * Individuals meeting criteria for cannabis use disorder or alcohol use disorder
  6. * Medical illness that can affect brain function
  7. * Past or present history of cardiovascular disease or high blood pressure
  8. * Any history of epilepsy or a known history of seizure disorder
  9. * A history of metal in the head or chest area (except dental fillings or braces)
  10. * Current consumption of psychiatric medication
  11. * Any other medical, neurological or neurosurgical condition that would preclude the administration of repetitive transmagnetic stimulation

Contacts and Locations

Study Contact

Brandon J Cornejo, MD, PhD
CONTACT
503-721-7964
brandon.cornejo@va.gov
Holly McCready
CONTACT
503-721-7964

Study Locations (Sites)

Veterans Affairs Portland Health Care System
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-07
Study Completion Date2025-09-01

Study Record Updates

Study Start Date2018-02-07
Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

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