Transcranial Magnetic Stimulation Used to Both Measure Cortical Excitability and Explore Methamphetamine Cue Craving

NCT01685463 | Completed Results

• 2 other identifiers: NIH/NIDA P20 DA022658P20DA022658
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Primary Aims include: Aim # 1. The investigators explore the feasibility of using the TMS to investigate the cortical excitability and to inhibit meth cue craving in meth dependent population. The investigators anticipate that meth elevates cortical excitability measured by motor threshold, causes changes of cortical silent period, and RC. The investigators also anticipate that paired pulse measures (short-interval intracortical inhibition, short-interval intracortical facilitation and long-interval intracortical inhibition) will be different from healthy control, which are more directly linked to glutamatergic cortical facilitation and GABAergic inhibition, respectively. Aim # 2. Given the change of the cortical excitability in meth users, the investigators will use inhibiting TMS (1 Hz) over medial prefrontal cortex to study whether TMS can be used to reduce cue craving. The investigators hypothesize that repetitive TMS reduce meth cue craving in meth dependent population compared with sham rTMS.

Conditions

Methamphetamine Dependence

Keywords

methamphetamine, craving, TMS, cortical excitability, prefrontal cortex

Outcome Measures

Primary Outcomes (1)

• Cue Craving Rating

  The subject is asked to rate craving with 0 mm being " no craving at all" and 100 mm representing "the most craving I have ever had".

  Change from Baseline in Craving rating 10 minutes after TMS

Secondary Outcomes (3)

• Change in Baseline of Resting Motor Threshold

  Baseline to 10 minutes after TMS

• Change in Cortical Silent Period

  Baseline and 10 minutes after TMS

• Change Recruitment Curve (RC) Slope

  Baseline and 10 minutes after TMS

Study Arms (2)

Transcranial Magnetic Stimulation

EXPERIMENTAL

Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technology that can focally stimulate the brain of an awake individual. The brain stimulation techniques could theoretically improve the efficacy of smoking cessation.

Device: Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

PLACEBO COMPARATOR

Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.

Device: Sham Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses. Electrical stimulation instead.

Also known as: Magstim Rapid

Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation DEVICE

The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS.

Also known as: Epix VT Transcutaneous Electrical Nerve Stimulation Device

Sham Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be volunteers who are dependent on meth and not currently seeking treatment. They must not have received substance abuse treatment within the previous 30 days.
• Be male or female of any race or ethnic group, between the ages of 18 and 50 years.
• Meet DSM IV criteria for meth dependence as determined by the MINI International Neuropsychiatric Interview (MINI).
• Currently be using meth by smoked, oral, or intravenous routes of administration, used meth for a minimum of 2 years and a minimum of an average of 3 times a week in the 30 days prior to screening.
• Be in stable mental and physical health.
• If female, test non-pregnant and use adequate birth control. All female subjects will have urine pregnancy tests in all three phases of the study.
• Be capable of providing written informed consent to participate in this study.
• Be able to comply with protocol requirements and be likely to complete all study procedures.
• Live within a 50 mile radius of our research program, have reliable transportation, and have a stable residence for at least the 30 days prior to starting the study.
• Be willing to abstain from alcohol, marijuana and CNS acting prescription and OTC medications for the 2 week screening and hospitalization phases.
• Have a positive urine for meth within 72 hours of admission to the hospital phase of the study and have at least one other positive urine for meth during the screening phase.
• Be right-handed.

You may not qualify if:

• Have current dependence, defined by DSM IV criteria, on any psychoactive substances other than meth, nicotine, or caffeine.
• Have a history and/or test positive for significant hepatic, renal, endocrine, cardiac, or inflammatory diseases, as well as stroke, seizures, migraine, serious head trauma, or other neurological disorders that might interfere with stability during the study or the acquisition of accurate fMRI scans.
• If female, have intentions to become pregnant during the study.
• Have been required by the courts to obtain treatment for meth or some other substance dependence.
• Be seeking treatment for meth or other substance dependence.
• Have a medical history or condition considered by the investigators to place the subject at increased risk (implanted ferrous materials or devices) or to decrease the likelihood of study completion.
• Be anticipating elective surgery or hospitalization within 8 weeks of signing the informed consent agreement.
• Be on medications in the last 30 days that may alter CNS function or alter fMRI results. Examples of such medications include but are not limited to the following: psychotropics, CNS active anti-hypertensives, steroids, anticonvulsants, antihistamines and CNS OTCs.
• Have a life time history of major Axis I disorders such as: BPAD, Schizophrenia, PTSD, or Dementia, or have a current history of Major Depression or suicide attempt within 12 months
• Have a self report of \>21 standard alcohol drinks per week in any week in the 30 days prior to screening or a Carbohydrate Deficient Transferrin \>3.0%.
• Be unwilling to use a patch and cease smoking cigarettes for the eight days in the hospital.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (3)

• Barr MS, Farzan F, Wing VC, George TP, Fitzgerald PB, Daskalakis ZJ. Repetitive transcranial magnetic stimulation and drug addiction. Int Rev Psychiatry. 2011 Oct;23(5):454-66. doi: 10.3109/09540261.2011.618827.

  PMID: 22200135 BACKGROUND

• Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.

  PMID: 19914283 BACKGROUND

• Li X, Malcolm RJ, Huebner K, Hanlon CA, Taylor JJ, Brady KT, George MS, See RE. Low frequency repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex transiently increases cue-induced craving for methamphetamine: a preliminary study. Drug Alcohol Depend. 2013 Dec 1;133(2):641-6. doi: 10.1016/j.drugalcdep.2013.08.012. Epub 2013 Aug 26.

  PMID: 24028801 DERIVED

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Xingbao Li
• Organization: Medical University of south Carolina

lixi@musc.edu

8437925729

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2012
• First Posted: September 14, 2012
• Study Start: September 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 1, 2020
• Results First Posted: October 19, 2018

Record last verified: 2020-03

Locations

US (1)