Cocaine UsePhase 1NCT01222806
Pilot Study of Repetitive Transcranial Magnetic Stimulation in Cocaine Craving
A Phase 1 study testing Repetitive Transcranial Magnetic Stimulation in people with Cocaine Use, run by National Institute on Drug Abuse (NIDA).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Oct 2010to 2 May 2013
- 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, or multiple sclerosis; or personal history of previous neurosurgery or 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 proconvulsive action, such as tricyclic antidepressants or neuroleptics (which lower seizure threshold).
- Increased intracranial pressure (lowers seizure threshold)
- Lifetime history of major depressive disorder, schizophrenia, bipolar disorder, mania, or hypomania
Show all 12Show 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 cocaine and/or nicotine.
- Claustrophobia making them unable to tolerate lying in the MRI scanner.
- History of HIV infection or positive HIV antibody test.
About this study
Official title: Pilot Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Cocaine Craving
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.
Read more
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.
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 cocaine craving and cocaine use in cocaine users.
Hypothesis: We predict that active rTMS will significantly lower craving for cocaine compared with sham rTMS.
Study population: Thirty healthy adult cocaine users (for at least 2 years, currently averaging at least 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 treatment. rTMS at 1 Hz and strength 120% of the motor threshold will be applied to the dorsolateral prefrontal cortex (DLPFC) using an H-coil (HADD version) contained in a helmet, beginning 1 second before presentation of a cocaine-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 treatment session (lasting around 31 minutes) will consist of 54 trials (cue presentations): 36 with cocaine-associated cues and 9 each with non-drug-associated positive or neutral cues. No rTMS will be administered with the non-cocaine-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 cocaine craving assessed by 100-mm visual analog scales before and after every TMS treatment and at one- and two week follow-up. Secondary outcome measures will be the 14-item Cocaine Craving Questionnaire, self-reported cocaine use, and urine drug testing at each rTMS session and follow-up visit, and changes in regional brain responses to cocaine-associated visual cues assessed by fMRI done before and after the 5 rTMS sessions.
Benefits: There is no direct benefit to individual subjects. The future benefit to society may be development of better methods for treatment of cocaine 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
- Cocaine Use
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Functional Magnetic Resonance Imaging (fMRI), Cocaine, Cue-Induced Craving, Repetitive TMS (rTMS), Cocaine Craving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Craving: cocaine craving questionnaire, visual-analogue scales
Measured: 2 weeks
Secondary outcomes (2)
Cocaine Use: urine drug tests, self-report
Measured: 2 weeks
Side-Effects: side-effect 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 posted18 Oct 2010 (estimated)
- Study start11 Oct 2010
- Study completion2 May 2013
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 Cocaine 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- David A Gorelick, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222806
- Sponsor's protocol ID
- 999911442
- Other IDs
- 11-DA-N442
- Status last verified
- 2 May 2013
- First submitted
- 15 Oct 2010
- Last updated
- 5 Jul 2018
- Results posted
- No
Publications
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.
PubMed 8651143Allen 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 15078569
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Cocaine Craving
- ClinicalTrials.gov ID
- NCT01222806
- Acronym / sponsor ID
- 999911442
- Conditions
- Cocaine Use
- Keywords
- Functional Magnetic Resonance Imaging (fMRI), Cocaine, Cue-Induced Craving, Repetitive TMS (rTMS), Cocaine 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
- Study start
- 11 Oct 2010
- Study completion
- 2 May 2013 (actual)
- First posted
- 18 Oct 2010 (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:
- 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.
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 cocaine craving and cocaine use in cocaine users.
Hypothesis: We predict that active rTMS will significantly lower craving for cocaine compared with sham rTMS.
Study population: Thirty healthy adult cocaine users (for at least 2 years, currently averaging at least 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 treatment. rTMS at 1 Hz and strength 120% of the motor threshold will be applied to the dorsolateral prefrontal cortex (DLPFC) using an H-coil (HADD version) contained in a helmet, beginning 1 second before presentation of a cocaine-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 treatment session (lasting around 31 minutes) will consist of 54 trials (cue presentations): 36 with cocaine-associated cues and 9 each with non-drug-associated positive or neutral cues. No rTMS will be administered with the non-cocaine-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 cocaine craving assessed by 100-mm visual analog scales before and after every TMS treatment and at one- and two week follow-up. Secondary outcome measures will be the 14-item Cocaine Craving Questionnaire, self-reported cocaine use, and urine drug testing at each rTMS session and follow-up visit, and changes in regional brain responses to cocaine-associated visual cues assessed by fMRI done before and after the 5 rTMS sessions.
Benefits: There is no direct benefit to individual subjects. The future benefit to society may be development of better methods for treatment of cocaine 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
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 (12 listed)
- 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.
- 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 proconvulsive action, such as tricyclic antidepressants or neuroleptics (which lower seizure threshold).
- 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 Stimulation | Device | – |
Primary outcome
Cocaine Craving: cocaine craving questionnaire, visual-analogue scales
Time frame: 2 weeks
2 secondary outcomes
Cocaine Use: urine drug tests, self-report
Time frame: 2 weeks
Side-Effects: side-effect 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 5 Jul 2018.
- Background: PubMed 8651143Agosti 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.
- 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.
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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.
David A Gorelick, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Repetitive Transcranial Magnetic Stimulation in people with Cocaine Use, run by National Institute on Drug Abuse (NIDA).
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 12 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 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Cocaine Craving: cocaine craving questionnaire, 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 NCT01222806, 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 5 Jul 2018.