Transcranial Magnetic Stimulation for Adolescents and Young Adults With Cannabis Use Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-21
SponsorUniversity of Minnesota
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
15-21 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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Magstim SuperRapid2
DeviceIntermittent 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)
Sham rTMS
DeviceAll 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).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Active rTMSActive comparator 1 intervention
Group B: Sham rTMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility, tolerability, and acceptability of rTMS
Daily side-effects reports on each intervention day and an exit interview will be collected.
Time frame
Month 42
rTMS effects on neural target engagement
Pre- and post-intervention resting connectivity fMRI data will be collected to examine changes in LDLPFC-cACC connectivity
Time frame
Month 43
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.
Time frame
Month 4Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: