50 Participants NeededMy employer runs this trial

Transcranial Magnetic Stimulation for Cannabis Use

(iCURE Trial)

Recruiting at 1 trial location
TK
Overseen ByTonisha Kearney-Ramos, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether repetitive transcranial magnetic stimulation (rTMS) can help reduce cannabis use. Researchers aim to determine if this treatment decreases attention to cannabis-related cues, which often lead to relapse. Participants will receive either the real rTMS treatment or a sham (placebo) version and will be monitored for changes in cannabis use and brain activity. The trial seeks frequent cannabis users who are seeking treatment and can commit to attending multiple sessions over a two-week period. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research in addiction treatment.

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

Research has shown that intermittent Theta Burst Stimulation (iTBS), a type of brain stimulation, is well-tolerated. One study found that using iTBS for two weeks did not cause harmful effects, indicating its safety for short-term use. Researchers have also tested it safely in various conditions, such as alcohol use disorder. While further research is beneficial, these findings suggest that iTBS could be a safe option for reducing cannabis cravings.12345

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) for cannabis use is unique because it offers a non-invasive, brain-targeted approach to managing addiction. Unlike standard treatments for cannabis use disorder, which often involve behavioral therapies and medications, TMS uses iTBS (intermittent Theta Burst Stimulation) to directly modulate brain activity. Researchers are excited about TMS because it targets specific neural circuits associated with craving and addiction, potentially reducing cannabis use without the side effects associated with traditional medications. This method could represent a groundbreaking shift in treating cannabis dependence, offering rapid results with minimal discomfort.

What evidence suggests that this treatment might be an effective treatment for cannabis use disorder?

Research has shown that intermittent theta burst stimulation (iTBS), a form of brain stimulation, might help reduce substance use. Studies have found that iTBS can lower the number of drinking days for people who use alcohol and reduce cravings for cocaine and methamphetamine. This treatment targets brain areas linked to addiction, potentially decreasing the focus on drug-related cues that can cause relapse. In this trial, participants will receive either active iTBS or a sham treatment to evaluate its effects on cannabis use disorder. While iTBS has proven effective for other substance use issues, its effects on cannabis use disorder remain under investigation. Early results suggest it might reduce cannabis cravings and use by altering how the brain responds to cannabis-related cues.12356

Who Is on the Research Team?

TK

Tonisha Kearney-Ramos, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults who currently use cannabis heavily and are seeking treatment. Participants must be able to complete all study procedures, not use other illicit drugs, and have no significant medical or psychiatric conditions that would make participation unsafe.

Inclusion Criteria

Able to perform all study procedures
You are currently using cannabis.

Exclusion Criteria

You are using illegal drugs.
If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process reveal any significant illness that the study physician deems contraindicated for study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Pre-treatment/Baseline

Cannabis use is assessed in participants' everyday environments using brief text-message surveys

2 weeks
Remote assessments via text-message surveys

Treatment

Participants receive either active or sham rTMS, with 25 sessions delivered over five days

2 weeks
5 visits (in-person) per week

Follow-up

Participants are monitored for changes in cannabis use and brain activity post-treatment

4 weeks
4 visits (in-person) for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

  • iTBS

Trial Overview

The study tests whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, can help reduce attention to cannabis cues and lower cannabis use compared to a placebo (sham) treatment. Participants receive 25 sessions over two weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention

iTBS is already approved in United States for the following indications:

🇺🇸
Approved in United States as iTBS for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

New York State Psychiatric Institute

Lead Sponsor

Trials
481
Recruited
154,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

The Effect of Intermittent Theta Burst Stimulation (iTBS) in ...

The primary outcome of the study will be decrease of visual analogue scale (VAS) scores from baseline to the end of treatment. iTBS is effective for alcohol ...

A randomized, double-blind, placebo-controlled clinical trial

Relative to participants who received Sham iTBS, those who received Active iTBS showed a significantly greater reduction in percent heavy drinking days and a ...

Intermittent Theta Burst Stimulation of the Prefrontal Cortex ...

The results indicate that iTBS produces effects on cocaine consumption and cocaine craving virtually superimposable to the 15 Hz rTMS group.

NCT05401929 | Transcranial Magnetic Brain Stimulation to ...

The primary objectives of this K01 research project are to: determine whether L DLPFC aiTBS decreases cannabis use using real-time data collected in the ...

The effects of intermittent theta burst stimulation (iTBS) on ...

Intermittent theta burst stimulation (iTBS), has shown superior therapeutic effects for depression compared to conventional high-frequency rTMS (HF-rTMS). ...

Transcranial Magnetic Stimulation for Cannabis Use Disorder

Others may receive continuous theta burst stimulation (cTBS), which evidence suggests can safely decrease cannabis use frequency. Additionally, some ...