CannabisNCT03538288
Feasibility Trial of rTMS for Cannabis Use Disorder
A study testing rTMS in people with Cannabis, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This small pilot trial will recruit 10 cannabis use disordered participants and apply 20 sessions of rTMS in conjunction with a two session Brief Marijuana Dependance Counseling treatment paradigm. The investigators are primarily seeking to determine if the proposed paradigm is feasible and well tolerated. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cannabis
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 1 Jul 2017
- 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
- Women only
- 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-5 criteria for at least moderate Cannabis Use Disorder, with use of at least 20 / last 28 days.
- Participants must express a desire to quit cannabis.
- Participants must have a positive UDS for cannabis during their enrollment visit (confirming they are regular users).
Who cannot join
- Participants must not be pregnant or breastfeeding.
- Participants must not test positive for any substance other than cannabis on UDS during their enrollment visit.
- Participants must not meet moderate or severe use disorder of any other substance with the exception of Tobacco 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 or bipolar disorder.
- Participants must not have any other Axis I condition requiring current treatment and must have a HRSD24 ≤10 indicating no clinically relevant depressive symptoms.
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- Participants must not have a history of dementia or other cognitive impairment.
- Participants must not have active suicidal ideation or a suicide attempt within the past 90 days.
- Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the head, history of seizure, any known brain lesion).
- Participants must not have any unstable general medical conditions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Pilot Trial Determining the Feasibility of Delivering Twenty Treatments of Repetitive Transcranial Magnetic Stimulation (rTMS) to Treatment Seeking Cannabis Use Disordered Participants
This small pilot trial will recruit 10 cannabis use disordered participants and apply 20 sessions of rTMS in conjunction with a two session Brief Marijuana Dependance Counseling treatment paradigm. The investigators are primarily seeking to determine if the proposed paradigm is feasible and well tolerated.
Read the detailed description
The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS is feasible and well tolerated by a group of treatment seeking CUD patients (Aim1). The investigators are also hoping to preliminarily determine if a course of rTMS reduces cannabis cue-induced craving (Aim2). Additionally the investigators want to preliminarily explore the mechanistic underpinnings of any observed effect by collecting functional magnetic resonance imaging (fMRI) data during cannabis cue-administration before and after the treatment course (Aim 3). These aims will be addressed through an open label study in which 10 treatment seeking cannabis use disordered participants will be given 20 sessions of Active excitatory rTMS applied to the DLPFC. TMS will be delivered in an accelerated fashion over two weeks (2 sessions each day, five days each week). TMS will be applied in conjunction with a validated two-session Motivational Enhancement Therapy (MET) behavioral intervention.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
rTMS will be applied at 10 Hz to the DLPFC
| Study group | Role | What they receive |
|---|---|---|
| Twenty sessions of rTMS | Experimental | Twenty sessions of rTMS will be applied to treatment seeking participants. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if a course of rTMS is feasible to deliver and well tolerated by a group of cannabis use disordered participants.
The investigators will test the hypothesis that at least 50% of enrolled participants will complete the trial.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Oct 2016
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Sahlem, Principal investigator, Instructor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538288
- Sponsor's protocol ID
- Pro00054706
- Status last verified
- May 2018
- First submitted
- 7 Sep 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 Pilot Trial Determining the Feasibility of Delivering Twenty Treatments of Repetitive Transcranial Magnetic Stimulation (rTMS) to Treatment Seeking Cannabis Use Disordered Participants
- ClinicalTrials.gov ID
- NCT03538288
- Acronym / sponsor ID
- Pro00054706
- Conditions
- Cannabis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 29 May 2018 (actual)
- 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 small pilot trial will recruit 10 cannabis use disordered participants and apply 20 sessions of rTMS in conjunction with a two session Brief Marijuana Dependance Counseling treatment paradigm. The investigators are primarily seeking to determine if the proposed paradigm is feasible and well tolerated.
Detailed description
The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS is feasible and well tolerated by a group of treatment seeking CUD patients (Aim1). The investigators are also hoping to preliminarily determine if a course of rTMS reduces cannabis cue-induced craving (Aim2). Additionally the investigators want to preliminarily explore the mechanistic underpinnings of any observed effect by collecting functional magnetic resonance imaging (fMRI) data during cannabis cue-administration before and after the treatment course (Aim 3). These aims will be addressed through an open label study in which 10 treatment seeking cannabis use disordered participants will be given 20 sessions of Active excitatory rTMS applied to the DLPFC. TMS will be delivered in an accelerated fashion over two weeks (2 sessions each day, five days each week). TMS will be applied in conjunction with a validated two-session Motivational Enhancement Therapy (MET) behavioral intervention.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Twenty sessions of rTMS | Experimental | Device: rTMSTwenty sessions of rTMS will be applied to treatment seeking participants. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- 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-5 criteria for at least moderate Cannabis Use Disorder, with use of at least 20 / last 28 days.
- Participants must express a desire to quit cannabis.
- Participants must have a positive UDS for cannabis during their enrollment visit (confirming they are regular users).
Key exclusion criteria (10 listed)
- Participants must not be pregnant or breastfeeding.
- Participants must not test positive for any substance other than cannabis on UDS during their enrollment visit.
- Participants must not meet moderate or severe use disorder of any other substance with the exception of Tobacco 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 or bipolar 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 |
|---|---|---|
| rTMSrTMS will be applied at 10 Hz to the DLPFC | Device | Twenty sessions of rTMS |
Primary outcome
Determine if a course of rTMS is feasible to deliver and well tolerated by a group of cannabis use disordered participants.
Time frame: 7 weeks
The investigators will test the hypothesis that at least 50% of enrolled participants will complete the trial.
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.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Instructor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Cannabis, run by Medical University of South Carolina 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 5 inclusion and 10 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.
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. 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?
Determine if a course of rTMS is feasible to deliver and well tolerated by a group of cannabis use disordered participants. (time frame: 7 weeks). 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.