Status:
WITHDRAWN
Pilot Study of Repetitive Transcranial Magnetic Stimulation in Cocaine Craving
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Use
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Background: \- Cocaine addiction is often difficult to treat, particularly because exposure to others using cocaine or to pictures of cocaine may evoke cocaine craving and lead a person to resume coc...
Detailed Description
Primary objective: Repetitive transcranial magnetic stimulation (rTMS) provides a non-invasive means of altering brain neural activity. This pilot study will test whether 5 days of rTMS reduces cue-in...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- i) Eighteen to sixty-five years of age
- ii) Cocaine user for at least 2 years, currently averaging at least 3 times weekly, with period of continuous abstinence no longer than one month within the past year
- iii) Reading level of at least 6th grade, based on the Wide Range Achievement Test (WRAT)
- iv) Ability to give valid informed consent
- v) Right-handed
- vi) If the subject is female and of childbearing potential, she agrees to use a medically acceptable form of contraception, and not become pregnant for the duration of the study. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. Female patients of childbearing potential must use either: (1) contraceptive pill or IUD or depot hormonal preparation (ring, injection, implant); and/or (2) a barrier method of contraception such as diaphragm, sponge with spermicide, or condom.
- Contraceptive measures will be reviewed with female subjects at each visit prior to the rTMS treatment.
- vii) Self-report experiencing cocaine craving when exposed to cocaine-associated cues
- EXCLUSION CRITERIA:
- i) Personal or first-degree family history of any clinically defined neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, or multiple sclerosis; or personal history of previous neurosurgery or head trauma that resulted in loss of consciousness.
- ii) Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head that cannot be safely removed.
- iii) Metal shrapnel or bullet in the head or body, including metal shavings.
- iv) Current use of any investigational drug or of any medications with anti- or proconvulsive action, such as tricyclic antidepressants or neuroleptics (which lower seizure threshold).
- v) Increased intracranial pressure (lowers seizure threshold)
- vi) Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania
- vii) History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care.
- viii) Pregnant or nursing women or women with reproductive potential not using an acceptable form of contraception.
- ix) Any history of seizure
- x) Current dependence (DSM-IV criteria) on substances other than cocaine and/or nicotine.
- xi) Claustrophobia making them unable to tolerate lying in the MRI scanner.
- xii) History of HIV infection or positive HIV antibody test.
Exclusion
Key Trial Info
Start Date :
October 11 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01222806
Start Date
October 11 2010
End Date
May 2 2013
Last Update
July 5 2018
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