24 Participants NeededMy employer runs this trial

Transcranial Magnetic Stimulation for Cannabis Use Disorder

(CAPE Trial)

BS
Overseen ByBrandon Schermitzler, M.S.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if transcranial magnetic stimulation (TMS) can help individuals recognize issues related to their cannabis use. TMS is a non-invasive method that influences brain activity. Researchers seek to understand if altering activity in a specific brain area affects individuals' perceptions of their cannabis habits. Participants will undergo various types of TMS, including active continuous theta burst stimulation (cTBS), active intermittent theta burst stimulation (iTBS), and sham TMS, and will answer questions to assess any changes. Suitable candidates have severe cannabis use disorder, regularly use cannabis, and face cannabis-related issues in daily life. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on cannabis use and brain activity.

Will I have to stop taking my current medications?

Yes, if you are currently taking any daily psychotropic medication, you will not be eligible to participate in this trial.

What prior data suggests that transcranial magnetic stimulation is safe for cannabis use disorder?

A previous study found that the safety of transcranial magnetic stimulation (TMS) is similar for people with substance use disorders (SUDs) and the general population. This finding indicates that TMS can be safely used for those with SUDs, including cannabis use disorder (CUD). Research on two types of TMS, intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS), shows that these treatments are generally well-tolerated. Side effects are usually mild and may include headaches or scalp discomfort, but these effects are typically short-lived. Overall, many studies have considered TMS safe for those with substance use issues.12345

Why are researchers excited about this trial?

Researchers are excited about using Transcranial Magnetic Stimulation (TMS) for Cannabis Use Disorder because it offers a non-invasive approach that directly targets brain activity. Unlike traditional treatments, which often rely on behavioral therapies or medications to manage symptoms, TMS uses magnetic fields to stimulate specific brain regions, potentially reducing cravings and dependency. This technique, including its variations of continuous (cTBS) and intermittent theta burst stimulation (iTBS), allows for a more tailored approach to modifying brain circuits involved in addiction. Moreover, the inclusion of a sham component helps ensure the validity of the effects observed, making it a promising avenue for those who have not responded to standard treatments.

What evidence suggests that this trial's treatments could be effective for cannabis use disorder?

Research has shown that transcranial magnetic stimulation (TMS) can assist with substance use issues, such as cannabis use disorder (CUD). This trial will compare different TMS approaches. Participants may receive intermittent theta burst stimulation (iTBS), which studies have shown reduces focus on drug-related cues and cravings. Others may receive continuous theta burst stimulation (cTBS), which evidence suggests can safely decrease cannabis use frequency. Additionally, some participants will receive a sham TMS treatment for comparison. Overall, TMS is considered safe and might offer a new way to help those with cannabis use problems.25678

Are You a Good Fit for This Trial?

This trial is for adults with severe cannabis use disorder who have used cannabis at least four days a week over the past year, test positive for THC in urine, and can read and write in English.

Inclusion Criteria

I have been diagnosed with severe Cannabis Use Disorder recently.
I have used cannabis on average four days a week for the past year.
I have tested positive for THC in a urine test.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants undergo theta burst stimulation (TBS) sessions and complete MRI and EEG scans

3 weeks
4 visits (in-person)

Follow-up

Participants are monitored for changes in cannabis use-related problem recognition

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • TMS - Active cTBS
  • TMS - Active iTBS
  • TMS - Sham

Trial Overview

The study tests three types of transcranial magnetic stimulation (TMS)—two active forms and one sham—on brain activity to see if they affect how people recognize problems related to their cannabis use. Each participant tries all three TMS types.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Intermittent Theta Burst Stimulation (iTBS)Experimental Treatment1 Intervention
Group II: Continuous Theta Burst Stimulation (cTBS)Experimental Treatment1 Intervention
Group III: Sham Theta Burst Stimulation (TBS)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials
81
Recruited
14,600+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Society of Addiction Psychology

Collaborator

Trials
2
Recruited
30+

Citations

A Preliminary Investigation Of Repetitive Transcranial ... - PMC

This trial suggests rTMS is safe and feasible in individuals with CUD and may have a therapeutic effect on frequency of cannabis use, though further study is ...

NCT05401929 | Transcranial Magnetic Brain Stimulation to ...

Building on prior data, the primary goal of this study is to evaluate the feasibility and effectiveness of TMS as a tool to decrease attention to drug cues and ...

TMS for the functional evaluation of cannabis effects and ...

In this scoping review, we summarize and discuss studies that have employed TMS and rTMS techniques in users of cannabis for recreational purposes.

Effectiveness of Noninvasive Brain Stimulation Protocols ...

Interpretation: Our results provide evidence that TMS and tES stimulation over frontopolar and DLPFC regions produce medium to large effect ...

Repetitive transcranial magnetic stimulation as a potential ...

Currently, the most widely implemented interventions for CUD remain psychotherapeutic approaches, including cognitive-behavioral therapy, psychosocial therapies ...

Evidence for safety and tolerability of transcranial magnetic ...

The prevalence of side effects from TMS in people with SUDs is comparable to that in the general population. TMS can be just as safely administered for SUDs as ...

Repetitive Transcranial Magnetic Stimulation in Substance ...

Ongoing accumulation and evaluation of safety data in patients with SUDs receiving rTMS is essential for providing up-to-date guidance for ...

A preliminary randomized controlled trial of repetitive ...

This trial suggests rTMS is safe and feasible in individuals with CUD and may have a therapeutic effect on frequency of cannabis use.