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Methamphetamine DependenceNCT01685463

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

A study testing Transcranial Magnetic Stimulation in people with Methamphetamine Dependence, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Methamphetamine Dependence
What is being tested?
Transcranial Magnetic Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteUnited States
Study dates
Sep 2008to Sep 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

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.

Being tested
Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
Keywords
methamphetamine, craving, TMS, cortical excitability, prefrontal cortex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Magnetic StimulationDevice

    Also called Magstim Rapid

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

  • Sham Transcranial Magnetic StimulationDevice

    Also called Epix VT Transcutaneous Electrical Nerve 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.

Study groups in NCT01685463
Study groupRoleWhat they receive
Transcranial Magnetic StimulationExperimentalTranscranial 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.
Receives: Device: Transcranial Magnetic Stimulation
Sham Transcranial Magnetic StimulationPlacebo comparatorSham-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.
Receives: Device: Sham Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: Change from Baseline in Craving rating 10 minutes after TMS

Secondary outcomes (3)

  1. Change in Baseline of Resting Motor Threshold

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

    Measured: Baseline to 10 minutes after TMS

  2. Change in Cortical Silent Period

    Cortical Silent Period is measured in seconds

    Measured: Baseline and 10 minutes after TMS

  3. Change Recruitment Curve (RC) Slope

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

    Measured: Baseline and 10 minutes after TMS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2012 (estimated)
  2. Study startSep 2008
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01685463
Sponsor's protocol ID
NIH/NIDA P20 DA022658
Other IDs
P20DA022658
Status last verified
Mar 2020
First submitted
10 Sep 2012
Last updated
1 Apr 2020
Data monitoring committee
No

Publications

  • 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.

    PubMed 22200135

  • 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.

    PubMed 19914283

  • 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.

    PubMed 24028801

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Magnetic Stimulation in people with Methamphetamine Dependence, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cue Craving Rating (time frame: Change from Baseline in Craving rating 10 minutes after TMS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01685463, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.

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