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OpenTrials
Completed

NCT Number: NCT01685463

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

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

Other names: Magstim Rapid

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.

Other names: Epix VT Transcutaneous Electrical Nerve Stimulation Device

Primary outcomes

  1. Cue Craving Rating

    Time frame: Change from Baseline in Craving rating 10 minutes after TMS

    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".

Secondary outcomes

  1. Change in Baseline of Resting Motor Threshold

    Time frame: Baseline to 10 minutes after TMS

    Resting motor threshold (RMT); on a scale of 0-100 with 100 being most power given to enact a motor response

  2. Change in Cortical Silent Period

    Time frame: Baseline and 10 minutes after TMS

    Cortical Silent Period is measured in seconds

  3. Change Recruitment Curve (RC) Slope

    Time frame: Baseline and 10 minutes after TMS

    Recruitment Curve (RC) Slope, measured at angle of slope

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Sep 14, 2012
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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