Cannabis UsePhase 1NCT01031290
Pilot Study Repetitive Transcranial Magnetic Stimulation (rTMS) in Cannabis Craving
A Phase 1 study testing Repetitive Transcranial Magnetic Stimulation in people with Cannabis Use, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cannabis Use
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2009to 27 Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
- 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.
- Metal shrapnel or bullet in the head or body including metal shavings.
- Current use of any investigational drug or of any medications with anti or pro-convulsive action
- Increased intracranial pressure (lowers seizure threshold)
- Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania
Show all 11Show fewer
- History of myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, or any heart condition currently under medical care.
- Pregnant or nursing women or women with reproductive potential not using an acceptable form of contraception.
- Any history of seizure
- Current dependence (DSM-IV criteria) on substances other than cannabis or nicotine.
- Claustrophobia making them unable to tolerate lying in the MRI scanner
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue
Catonsville, Maryland, 21228
About this study
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.
Read more
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.
Read the 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-induced cannabis craving and use in cannabis users.
Hypothesis:
We predict that active rTMS will significantly lower craving for cannabis compared with sham rTMS.
Study population:
Thirty healthy adult cannabis users (for at least 2 years, currently averaging 3 times weekly) with no other major psychiatric disorders except nicotine dependence (DSM IV criteria) will be recruited from the community.
Design:
Following a baseline phase to evaluate subject characteristics, subjects will be randomly assigned to receive 5 days of active or sham rTMS. rTMS at 1 Hz and strength 120% of the motor threshold will be applied to the dorsolateral prefrontal cortex (DLPFC) using a figure 8 coil , beginning 1 second after presentation of a cannabis-associated visual cue and lasting for 30 seconds. Brain site localization will use a computerized navigation system based on structural MRI scans obtained before the first session. Each rTMS session (lasting around 31 minutes) will consist of 54 trials (cue presentations): 36 with cannabis-associated cues and 9 each with non-drug-associated positive or neutral cues. No rTMS will be administered with the non-cannabis-associated cues. Subjects return for follow-up assessments one and two weeks after the final rTMS session.
Outcome measures:
The primary outcome measure will be cannabis craving assessed by the Marijuana Craving Questionnaire and visual analog scales before and after every rTMS session and at one- and two-week follow-up. Secondary outcome measures will be self-reported cannabis use and urine drug testing at each rTMS session and follow-up visit, and changes in regional brain responses to cannabis-associated visual cues assessed by fMRI done before and after the 5 rTMS sessions.
Benefits:
The future benefit to society may be development of better methods for treatment of cannabis addiction.
Risks:
The primary risks from rTMS are transient headache, scalp discomfort, decreased spatial recognition memory, and hearing loss (minimized by wearing ear plugs). Seizures are very rare when rTMS is administered within accepted safety guidelines and individuals at increased risk of seizures are excluded. The risk of inducing a manic episode is minimized by excluding individuals with a history of non-drug-induced mania/hypomania.
- Conditions
- Cannabis Use
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Cue-Induced Craving, Cannabis, Functional Magnetic Resonance Imaging (fMRI), Repetitive TMS (rTMS), Cannabis Craving
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
daily sessions for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Active TMS Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Group B | Sham comparator | Sham TMS Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis craving by Marijuana Craving Questionnaire and visual-analogue scales.
Measured: 2 weeks
Secondary outcomes (1)
Cannabis use by urine drug testing and self-report; Safety and tolerability, using side-effects checklist.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start19 Aug 2009
- Primary completion31 Jan 2012
- Study completion27 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031290
- Sponsor's protocol ID
- 999909443
- Other IDs
- 09-DA-N443
- Status last verified
- 27 Feb 2012
- First submitted
- 11 Dec 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 17901333Bestmann 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.
PubMed 15078569Brody 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.
PubMed 12470133
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Repetitive Transcranial Magnetic Stimulation (rTMS) in Cannabis Craving
- ClinicalTrials.gov ID
- NCT01031290
- Acronym / sponsor ID
- 999909443
- Conditions
- Cannabis Use
- Keywords
- Cue-Induced Craving, Cannabis, Functional Magnetic Resonance Imaging (fMRI), Repetitive TMS (rTMS), Cannabis Craving
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- University of Maryland
- Study start
- 19 Aug 2009
- Primary completion
- 31 Jan 2012 (actual)
- Study completion
- 27 Feb 2012 (actual)
- First posted
- 14 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-induced cannabis craving and use in cannabis users.
Hypothesis:
We predict that active rTMS will significantly lower craving for cannabis compared with sham rTMS.
Study population:
Thirty healthy adult cannabis users (for at least 2 years, currently averaging 3 times weekly) with no other major psychiatric disorders except nicotine dependence (DSM IV criteria) will be recruited from the community.
Design:
Following a baseline phase to evaluate subject characteristics, subjects will be randomly assigned to receive 5 days of active or sham rTMS. rTMS at 1 Hz and strength 120% of the motor threshold will be applied to the dorsolateral prefrontal cortex (DLPFC) using a figure 8 coil , beginning 1 second after presentation of a cannabis-associated visual cue and lasting for 30 seconds. Brain site localization will use a computerized navigation system based on structural MRI scans obtained before the first session. Each rTMS session (lasting around 31 minutes) will consist of 54 trials (cue presentations): 36 with cannabis-associated cues and 9 each with non-drug-associated positive or neutral cues. No rTMS will be administered with the non-cannabis-associated cues. Subjects return for follow-up assessments one and two weeks after the final rTMS session.
Outcome measures:
The primary outcome measure will be cannabis craving assessed by the Marijuana Craving Questionnaire and visual analog scales before and after every rTMS session and at one- and two-week follow-up. Secondary outcome measures will be self-reported cannabis use and urine drug testing at each rTMS session and follow-up visit, and changes in regional brain responses to cannabis-associated visual cues assessed by fMRI done before and after the 5 rTMS sessions.
Benefits:
The future benefit to society may be development of better methods for treatment of cannabis addiction.
Risks:
The primary risks from rTMS are transient headache, scalp discomfort, decreased spatial recognition memory, and hearing loss (minimized by wearing ear plugs). Seizures are very rare when rTMS is administered within accepted safety guidelines and individuals at increased risk of seizures are excluded. The risk of inducing a manic episode is minimized by excluding individuals with a history of non-drug-induced mania/hypomania.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Repetitive Transcranial Magnetic StimulationActive TMS |
| Group B | Sham comparator | Device: Repetitive Transcranial Magnetic StimulationSham TMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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.
- 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.
- Metal shrapnel or bullet in the head or body including metal shavings.
- Current use of any investigational drug or of any medications with anti or pro-convulsive action
- Increased intracranial pressure (lowers seizure threshold)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulationdaily sessions for 5 days | Device | Group A, Group B |
Primary outcome
Cannabis craving by Marijuana Craving Questionnaire and visual-analogue scales.
Time frame: 2 weeks
1 secondary outcome
Cannabis use by urine drug testing and self-report; Safety and tolerability, using side-effects checklist.
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 17901333Allen 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.
- Background: PubMed 15078569Bestmann 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.
- Background: PubMed 12470133Brody 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Repetitive Transcranial Magnetic Stimulation in people with Cannabis Use, run by National Institute on Drug Abuse (NIDA) 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 0 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: withdrawn, as of the sponsor's last update on 2 Jul 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cannabis craving by Marijuana Craving Questionnaire and visual-analogue scales. (time frame: 2 weeks). 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 NCT01031290, 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 2 Jul 2017.