Pilot Study of Repetitive Transcranial Magnetic Stimulation in Cocaine Craving

NCT01222806 | Withdrawn Phase 1

• 2 other identifiers: 99991144211-DA-N442
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 cocaine use after having quit. Breaking this link with cocaine craving might improve treatment for cocaine addiction. Research suggests that repetitive pulses of transcranial magnetic stimulation (rTMS) applied to the skull can change nerve cell firing in the brain. rTMS was recently approved as a treatment for depression, and is being studied as a way to reduce drug craving. However, because only a few small studies have looked at the effects of rTMS on cocaine craving, more research is needed on whether it is effective in reducing cocaine craving and use in individuals who currently use cocaine on a regular basis. Objectives: \- To determine whether transcranial magnetic stimulation can lower craving for cocaine when given in connection with cocaine-related images. Eligibility: \- Individuals at least 18 years of age who have used cocaine for at least 2 years and currently using at least 3 times per week. Design:

• This study involves an initial screening visit, two brain imaging sessions, five rTMS sessions, and two follow-up visits.
• Participants will be screened with a medical history, physical examination, urine samples, questions about drug use history and previous efforts to quit, and tests for breath alcohol and nicotine levels.
• Participants will have two magnetic resonance imaging (MRI) scan sessions: one baseline scanning session before starting their rTMS sessions and a second scanning session after their last rTMS session . Part of each scanning session involves functional MRI (fMRI) scans. During the fMRI scans, participants will look at pictures related to cocaine use and pictures that are not related to cocaine use. Participants will also perform a simple decision task during the scans.
• Participants will have five rTMS sessions, one per day for 5 days in a row. Each session will last 1 to 2 hours. Participants will have either real or sham (simulated) rTMS while looking at pictures that may or may not be related to cocaine use, and will also perform a simple decision task that is the same as the one given during the MRI scans. The decision as to whether participants get real or sham rTMS will be made by chance. Neither the participants nor the investigators will know which type the participants are getting. - Participants will have two follow-up visits one and two weeks after their last rTMS session. At each visit they will be checked for cocaine and other substance use and for possible side-effects from rTMS.

Conditions

Cocaine Use

Keywords

Functional Magnetic Resonance Imaging (fMRI); Cocaine; Cue-Induced Craving; Repetitive TMS (rTMS); Cocaine Craving

Outcome Measures

Primary Outcomes (1)

• Cocaine Craving: cocaine craving questionnaire, visual-analogue scales

  2 weeks

Secondary Outcomes (2)

• Cocaine Use: urine drug tests, self-report

  2 weeks

• Side-Effects: side-effect checklist

  2 weeks

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Related Publications (3)

• Agosti V, Nunes E, Ocepeck-Welikson K. Patient factors related to early attrition from an outpatient cocaine research clinic. Am J Drug Alcohol Abuse. 1996 Feb;22(1):29-39. doi: 10.3109/00952999609001643.

  PMID: 8651143 BACKGROUND

• Allen EA, Pasley BN, Duong T, Freeman RD. Transcranial magnetic stimulation elicits coupled neural and hemodynamic consequences. Science. 2007 Sep 28;317(5846):1918-21. doi: 10.1126/science.1146426.

  PMID: 17901333 BACKGROUND

• Bestmann S, Baudewig J, Siebner HR, Rothwell JC, Frahm J. Functional MRI of the immediate impact of transcranial magnetic stimulation on cortical and subcortical motor circuits. Eur J Neurosci. 2004 Apr;19(7):1950-62. doi: 10.1111/j.1460-9568.2004.03277.x.

  PMID: 15078569 BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• David A Gorelick, M.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: October 11, 2010
• Study Completion: May 2, 2013
• Last Updated: July 5, 2018

Record last verified: 2013-05-02