Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01685463
Other study ID # NIH/NIDA P20 DA022658
Secondary ID P20DA022658
Status Completed
Phase N/A
First received
Last updated
Start date September 2008
Est. completion date September 2014

Study information

Verified date March 2020
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (3)

Lead Sponsor Collaborator
Medical University of South Carolina National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Baseline to 10 minutes after TMS
Secondary Change in Cortical Silent Period Cortical Silent Period is measured in seconds Baseline and 10 minutes after TMS
Secondary Change Recruitment Curve (RC) Slope Recruitment Curve (RC) Slope, measured at angle of slope Baseline and 10 minutes after TMS
See also
  Status Clinical Trial Phase
Terminated NCT01813656 - An Study of Aripiprazole in the Treatment of Methamphetamine Dependence Phase 4
Completed NCT00984360 - Study of Naltrexone for Methamphetamine Addiction Phase 2
Completed NCT00569374 - Safety and Tolerability of Modafinil for Methamphetamine Dependence Phase 2
Completed NCT01967381 - Targeting GABA and Opioid Systems for a Pharmacotherapy for Methamphetamine Abuse Early Phase 1
Completed NCT01354470 - A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence Phase 2
Active, not recruiting NCT01044238 - Methylphenidate to Treat Methamphetamine Dependence Phase 2
Terminated NCT01019707 - Safety Assessment of Atomoxetine With MA IV Administration Phase 1
Completed NCT01215929 - Studying Amphetamine Withdrawal in Humans Phase 2
Completed NCT00227123 - A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence N/A
Recruiting NCT02568878 - Creatine for Depressed Male and Female Methamphetamine Users Phase 3
Completed NCT01011829 - Varenicline vs Placebo for the Treatment of Methamphetamine Dependence Phase 2
Completed NCT01007539 - Efficacy and Safety of CDP-choline in Patients With Methamphetamine Dependence Phase 3
Completed NCT01062451 - An ACE Inhibitor (Perindopril) or an Angiotensin Receptor Blocker (Candesartan) as a Treatment for Methamphetamine Dependence Phase 1
Completed NCT00687713 - Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence Phase 2
Completed NCT01063205 - NAC as a Potential Treatment for Methamphetamine Dependence Phase 1
Completed NCT02058966 - Pilot Study of Entacapone for Methamphetamine Abuse Early Phase 1
Completed NCT00332605 - N-Acetyl Cysteine Plus Naltrexone in Methamphetamine Dependence Phase 2
Completed NCT01860807 - Trial of Ibudilast for Methamphetamine Dependence Phase 2
Terminated NCT01813643 - A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis Phase 4
Completed NCT01073319 - Rivastigmine as a Treatment for Methamphetamine Dependence Phase 1