Pilot Study Repetitive Transcranial Magnetic Stimulation (rTMS) in Cannabis Craving

NCT01031290 | Withdrawn Phase 1

• 2 other identifiers: 99990944309-DA-N443
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Cannabis, also known as marijuana, is a commonly abused drug. There is no approved medication to treat cannabis addiction. The desire to use cannabis often increases when seeing others use it or seeing pictures of it. Researchers are interested in determining which parts of the brain are active when looking at pictures associated with cannabis.
• Repetitive transcranial magnetic stimulation (rTMS) uses magnetic pulses to stimulate the brain. These pulses can change activity in parts of the brain. Researchers are interested in determining whether rTMS can decrease activity in the parts of the brain that respond to cannabis, and thereby lessen cravings for cannabis. Objectives: \- To determine whether transcranial magnetic stimulation can lower craving for cannabis when people who use cannabis are shown images that increase craving. Eligibility: \- Individuals 18 years of age and older who are physically healthy and currently use cannabis (at least 3 times weekly for the past 2 years). Design:
• The study will involve eight visits over 3 weeks, with each visit lasting 1 to 2 hours.
• Participants will have an initial assessment about cannabis use and provide blood and urine samples before beginning the study.
• Participants will have three magnetic resonance imaging (MRI) brain scans. The first MRI scan will look at the structure of the brain at rest. During the other two scans, participants will look at images related to and not related to cannabis use.
• The rTMS sessions (with either actual TMS or inactive \[sham\] TMS) will be held daily for 5 consecutive days. During these testing visits, researchers will ask questions related to drug use and craving, and collect urine and breath samples for further study.
• Participants will have two follow-up visits, 1 week and 2 weeks after the rTMS sessions, to evaluate memory and mood, and one final MRI brain scan at the end of the study.

Conditions

Cannabis Use

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cannabis craving by Marijuana Craving Questionnaire and visual-analogue scales.

  2 weeks

Secondary Outcomes (1)

• Cannabis use by urine drug testing and self-report; Safety and tolerability, using side-effects checklist.

  2 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Active TMS

Device: Repetitive Transcranial Magnetic Stimulation

Group B

SHAM COMPARATOR

Sham TMS

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

daily sessions for 5 days

Group A; Group B

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) Cannabis user for at least 2 years, currently averaging 3 times weekly
• 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, of childbearing potential, and sexually active, 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 who are or who anticipate the possibility of becoming sexually active with a male partner 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. Women who are not sexually active do not have to agree to use one of the acceptable contraception methods. Contraceptive measures will be reviewed with female subjects at each visit prior to the rTMS treatment
• vii) Self-report experiencing cannabis craving when exposed to cannabis-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, multiple sclerosis, previous neurosurgery, or personal history of 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 pro-convulsive action
• 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 cannabis or nicotine.
• xi) Claustrophobia making them unable to tolerate lying in the MRI scanner

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• University of Maryland: collaborator

Study Sites (1)

Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue

Catonsville, Maryland, 21228, United States

Location

Related Publications (3)

• 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

• Brody AL, Mandelkern MA, London ED, Childress AR, Lee GS, Bota RG, Ho ML, Saxena S, Baxter LR Jr, Madsen D, Jarvik ME. Brain metabolic changes during cigarette craving. Arch Gen Psychiatry. 2002 Dec;59(12):1162-72. doi: 10.1001/archpsyc.59.12.1162.

  PMID: 12470133 BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 14, 2009
• Study Start: August 19, 2009
• Primary Completion: January 31, 2012
• Study Completion: February 27, 2012
• Last Updated: July 2, 2017

Record last verified: 2012-02-27

Locations

US (1)