NCT07634835

Brief Summary

This pilot study will investigate the potential of repetitive transcranial magnetic stimulation (rTMS) to strengthen a neural circuit critical for maintaining abstinence in adolescents and youth with cannabis use disorder (CUD).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
25mo left

Started Mar 2027

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2.1 years

First QC Date

June 2, 2026

Last Update Submit

June 2, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Feasibility, tolerability, and acceptability of rTMS

    Daily side-effects reports on each intervention day and an exit interview will be collected.

    Month 4

  • rTMS effects on neural target engagement

    Pre- and post-intervention resting connectivity fMRI data will be collected to examine changes in LDLPFC-cACC connectivity

    Month 4

  • Changes in CUD recovery metrics

    Cannabis craving will be measured using a validated self-report scale. Cannabis use will be evaluated during in-person monthly visits across a 3-month follow-up period, using interviewer-administered assessments and urine toxicology. An optional component of the study will include daily smartphone-based brief surveys to remotely track self-reported cannabis craving and use in real time.

    Month 4

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

During TMS, a pulsed magnetic field is produced by a small coil positioned over a targeted area on the scalp, inducing an electric current in the brain that temporarily modulates cortical activity. Repetitive TMS (rTMS) paradigms use trains of pulses to induce cortical effects that outlast the duration of stimulation.

Device: Magstim SuperRapid2

Sham rTMS

SHAM COMPARATOR

All sham participants will be exposed to the same procedures as the active rTMS condition but using the sham air-cooled coil. The sham coil looks and sounds the same as the active coil but it has a shield in it that blocks the magnetic field (so it is not stimulating the brain at all).

Device: Sham rTMS

Interventions

Intermittent burst stimulation (iTBS) bursts of 3 pulses at 30 Hz repeated every 200ms for 2 s (1 train), trains repeat every 10s apart (8s inter-burst interval between trains), 600 total pulses, 70% RMT (190 sec duration)

Active rTMS
Sham rTMSDEVICE

All sham participants will be exposed to the same procedures as the active rTMS condition but using the sham air-cooled coil. The sham coil looks and sounds the same as the active coil but it has a shield in it that blocks the magnetic field (so it is not stimulating the brain at all).

Sham rTMS

Eligibility Criteria

Age15 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old
  • For minors, parent/legal guardian able to provide consent and child able to provide assent; for adults, ability to self-consent per MacArthur Competence Assessment Tool for Clinical Research
  • Ability to comply with study procedures
  • Treatment-seeking youth diagnosed with CUD as per the Mini-International Neuropsychiatric Interview (MINI-KID (Sheehan et al., 2010) for 15-17 years old and MINI (Sheehan et al., 1998) for 18-21 years old)
  • Cannabis use 3+ days per week (or 12+ days in the past month) as verified by Timeline Followback (TLFB) (Sobell \& Sobell, 1996)
  • Fluent in spoken English

You may not qualify if:

  • Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, intracranial lesions, epilepsy or seizure disorders, or individuals with a family history of epilepsy or seizure in a first degree relative, traumatic brain injury, brain tumor, stroke, neurocardiogenic syncope, mania/bipolar disorder, implanted medical devices or metallic objects in the head, current pregnancy or not using effective contraception if capable of becoming pregnant, or any other serious medical condition or contraindication as judged by the study physician; moderate to severe heart disease, pediatric populations with risk factors for neurocardiogenic syncope (history of syncope/presyncope related to noxious stimuli, anxiety, micturation, or posture)
  • Inability to undergo MRI.
  • Diagnosis of psychosis, cognitive disability or active suicidality. The MINI (Sheehan et al., 1998, 2010) will be used to assess current psychiatric comorbidities and the Ask Suicide-Screening Questions (ASQ) will be used to assess suicidality (Horowitz et al., 2012).
  • Primary current alcohol or substance use disorder, except for caffeine or nicotine.
  • Taking a medication with high seizurogenic potential (e.g., clomipramine, tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, anti-psychotics, lithium, bupropion -e.g. Wellbutrin). Participants taking psychotropic medications will be included if dose is stable for ≥4 weeks with no anticipated changes during the study period. All concurrent treatments will be monitored during the study period.
  • If an individual is currently taking antibiotics that affect the central nervous system such as Fluoroquinolones (Ciprofloxacin, Levofloxacin, Moxifloxacin) or Imipenem, medications that have the potential of lowering seizure threshold, participation in the study will be delayed until 5 days after the last antibiotic dose.
  • If an individual is taking antihistamines (i.e. Benadryl/diphenhydramine), they will be asked to refrain from using the antihistamine for at least 24 hours before the TMS session. If the participant is not able to do so, they will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Jazmin Camchong, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jazmin Camchong, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 9, 2026

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Last Updated

June 9, 2026

Record last verified: 2026-06

Locations