CannabisNCT02567344
Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Cannabis, run by Medical University of South Carolina.
Trial summary
This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking Cannabis use disordered participants. Participants will then undergo either active, or sham rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cannabis
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2016
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Participants must be between the ages of 18 and 60.
- Participants must meet DSM-V criteria for Cannabis Use Disorder, with use of at least 20 days/month.
- Participants must agree to abstinence from Cannabis for at least 24 hours prior to each visit.
- Participants must have a Positive UDS for cannabis (confirming they are regular users), and a negative salivary cannabis test (Confirming no use within 10-14 hours)
Who cannot join
- Participants must not be pregnant and participate in the study.
- Participants must not test positive for any substance other than cannabis on UDS.
- Participants must not meet criteria for any other Substance Use Disorders with the exception of Nicotine Use Disorder.
- Participants must not be on any medications that have central nervous system effects.
- Participants Must not have a history of/or current Psychotic disorder.
- Participants must not have a history of Dementia or other cognitive impairment.
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- Participants must not have active suicidal ideation, or suicide attempt within the past 90 days.
- Participants must not have any contraindications to receiving rTMS as assessed by the TMS safety sheet.
- Participants must not have any unstable general medical conditions.
About this study
Official title: A Double Blind, Sham Controlled Trial of Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving and Impulsive Decision Making in Cannabis Use Disordered Participants.
This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking Cannabis use disordered participants. Participants will then undergo either active, or sham rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed.
Read the detailed description
Our primary aims are to determine the effect of a single session of 10 Hz L DLPFC rTMS on cannabis cue induced craving (Aim1), and behavioral tasks of impulsive decision making (Aim2), in non-treatment seeking individuals with Cannabis Use Disorder. The aims of the study will be accomplished by performing a double-blind, sham-controlled crossover trial. Non-Treatment seeking individuals with CUD will be recruited through media advertisements, as well as via a pre-established database of non-treatment seeking individuals who have participated in previous Cannabis trials and agreed to be re-contacted. Interested individuals will undergo a brief phone screen to determine if they meet general inclusion/exclusion criteria, and if so will be invited to meet with study personnel in order to sign informed consent, and undergo a screening visit. There will then be two experimental visits separated by at least one week. During each of these visits participants will undergo either a real, or sham rTMS treatment, as well as a cannabis cue Paradigm. Data on craving as well as on impulsive decision making will be collected before and after each treatment.
- Conditions
- Cannabis
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation
- Keywords
- Cannabis, rTMS, Craving, Decision making
- 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 Stimulation (rTMS)Device
rTMS will be delivered at 110% rMT to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
Sham Repetitive Transcranial Magnetic StimulationDevice
rTMS will be delivered via an electronic sham coil that mimics real rTMS in appearance, sound, and feeling. Pulses will be delivered to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | Active rTMS will be delivered to the Left DLPFC at 10Hz. A total of 4000 pulses will be delivered. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Sham rTMS | Sham comparator | Sham rTMS will be delivered to the Left DLPFC at 10 Hz using an electronic sham system used in multiple other investigations. A total of 4000 pulses of sham rTMS will be delivered. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marijuana Craving Questionnaire (MCQ)
The MCQ will be given before and after a marijuana-cue paradigm, and the primary outcome will be the change score from pre to post.
Measured: 15 Minutes
Secondary outcomes (1)
The Balloon Aptitude Response Task (BART)
The BART will be given pre, and post rTMS. Number of corrected pumps, and number of burst balloons will be collected.
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Sahlem, MD, Principal investigator, MUSC department of psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567344
- Sponsor's protocol ID
- Pro00047358
- Status last verified
- May 2018
- First submitted
- 1 Oct 2015
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Sham Controlled Trial of Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving and Impulsive Decision Making in Cannabis Use Disordered Participants.
- ClinicalTrials.gov ID
- NCT02567344
- Acronym / sponsor ID
- Pro00047358
- Conditions
- Cannabis
- Keywords
- Cannabis, rTMS, Craving, Decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Oct 2015 (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.
This is a double-blind, crossover trial that will recruit a cohort of non-treatment seeking Cannabis use disordered participants. Participants will then undergo either active, or sham rTMS to the LDLPFC, and cue-induced craving, and risky decision making will be assessed.
Detailed description
Our primary aims are to determine the effect of a single session of 10 Hz L DLPFC rTMS on cannabis cue induced craving (Aim1), and behavioral tasks of impulsive decision making (Aim2), in non-treatment seeking individuals with Cannabis Use Disorder. The aims of the study will be accomplished by performing a double-blind, sham-controlled crossover trial. Non-Treatment seeking individuals with CUD will be recruited through media advertisements, as well as via a pre-established database of non-treatment seeking individuals who have participated in previous Cannabis trials and agreed to be re-contacted. Interested individuals will undergo a brief phone screen to determine if they meet general inclusion/exclusion criteria, and if so will be invited to meet with study personnel in order to sign informed consent, and undergo a screening visit. There will then be two experimental visits separated by at least one week. During each of these visits participants will undergo either a real, or sham rTMS treatment, as well as a cannabis cue Paradigm. Data on craving as well as on impulsive decision making will be collected before and after each treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)Active rTMS will be delivered to the Left DLPFC at 10Hz. A total of 4000 pulses will be delivered. |
| Sham rTMS | Sham comparator | Device: Sham Repetitive Transcranial Magnetic StimulationSham rTMS will be delivered to the Left DLPFC at 10 Hz using an electronic sham system used in multiple other investigations. A total of 4000 pulses of sham rTMS will be delivered. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Participants must be between the ages of 18 and 60.
- Participants must meet DSM-V criteria for Cannabis Use Disorder, with use of at least 20 days/month.
- Participants must agree to abstinence from Cannabis for at least 24 hours prior to each visit.
- Participants must have a Positive UDS for cannabis (confirming they are regular users), and a negative salivary cannabis test (Confirming no use within 10-14 hours)
Key exclusion criteria (9 listed)
- Participants must not be pregnant and participate in the study.
- Participants must not test positive for any substance other than cannabis on UDS.
- Participants must not meet criteria for any other Substance Use Disorders with the exception of Nicotine Use Disorder.
- Participants must not be on any medications that have central nervous system effects.
- Participants Must not have a history of/or current Psychotic disorder.
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 (rTMS)rTMS will be delivered at 110% rMT to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses. | Device | Active rTMS |
| Sham Repetitive Transcranial Magnetic StimulationrTMS will be delivered via an electronic sham coil that mimics real rTMS in appearance, sound, and feeling. Pulses will be delivered to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses. | Device | Sham rTMS |
Primary outcome
Marijuana Craving Questionnaire (MCQ)
Time frame: 15 Minutes
The MCQ will be given before and after a marijuana-cue paradigm, and the primary outcome will be the change score from pre to post.
1 secondary outcome
The Balloon Aptitude Response Task (BART)
Time frame: 30 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
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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.
Gregory Sahlem, MD principal investigator
MUSC department of psychiatry
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Cannabis, run by Medical University of South Carolina.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 2 Aug 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. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Marijuana Craving Questionnaire (MCQ) (time frame: 15 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2018.