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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01685463
First received: September 10, 2012
Last updated: September 13, 2012
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Methamphetamine Dependence
Device: Transcranial Magnetic Stimulation
Device: Sham Transcranial Magnetic Stimulation
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation Used to Both Measure Cortical Excitability and Explore Methamphetamine Cue Craving

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Cue craving rating [ Time Frame: Change from Baseline in Craving rating 10 minutes after TMS ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • cortical excitability [ Time Frame: Change from Baseline in cortical excitability 10 minutes after TMS ] [ Designated as safety issue: No ]

    Cortical Excitability Include:

    Resting motor threshold (RMT); Cortical silent period (CSP); Recruitment curve (RC); Paired-pulse (PP)



Estimated Enrollment: 20
Study Start Date: September 2008
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial Magnetic Stimulation
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
Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses. Electrical stimulation instead.
Other Name: Magstim Rapid
Placebo Comparator: Sham Transcranial Magnetic Stimulation
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
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 Name: Epix VT Transcutaneous Electrical Nerve Stimulation Device

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Be male or female of any race or ethnic group, between the ages of 18 and 50 years.
  3. Meet DSM IV criteria for meth dependence as determined by the MINI International Neuropsychiatric Interview (MINI).
  4. 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.
  5. Be in stable mental and physical health.
  6. 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.
  7. Be capable of providing written informed consent to participate in this study.
  8. Be able to comply with protocol requirements and be likely to complete all study procedures.
  9. 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.
  10. Be willing to abstain from alcohol, marijuana and CNS acting prescription and OTC medications for the 2 week screening and hospitalization phases.
  11. 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.
  12. Be right-handed.

Exclusion Criteria:

  1. Have current dependence, defined by DSM IV criteria, on any psychoactive substances other than meth, nicotine, or caffeine.
  2. 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.
  3. If female, have intentions to become pregnant during the study.
  4. Have been required by the courts to obtain treatment for meth or some other substance dependence.
  5. Be seeking treatment for meth or other substance dependence.
  6. 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.
  7. Be anticipating elective surgery or hospitalization within 8 weeks of signing the informed consent agreement.
  8. 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.
  9. 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
  10. 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%.
  11. Be unwilling to use a patch and cease smoking cigarettes for the eight days in the hospital.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01685463

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Xingbao Li, M.D    843-792-5729    lixi@musc.edu   
Contact: Kristina Huebner    843 7921901    huebnerk@musc.edu   
Principal Investigator: Ronald E See, Ph.D         
Sub-Investigator: Xingbao Li, M.D         
Sponsors and Collaborators
Medical University of South Carolina
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01685463     History of Changes
Other Study ID Numbers: NIH/NIDA P20 DA022658, P20DA022658
Study First Received: September 10, 2012
Last Updated: September 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
methamphetamine, craving, TMS, cortical excitability, prefrontal cortex

Additional relevant MeSH terms:
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014