Clinical trial NCT03144232: A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder
Official title: A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis Use Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-05-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This investigation will preliminarily determine if a course of high-frequency rTMS applied to the left dorsolateral prefrontal cortex, will reduce behavioral craving, and fMRI cue-reactivity in treatment-seeking cannabis use disordered participants.

Detailed description: The overarching goal of this proposal is to investigate if a course of excitatory DLPFC rTMS results in reduced cannabis behavioral craving in treatment-seeking individuals with CUD (Aim1). Additionally, the investigators seek to explore the mechanistic underpinnings of any observed effect, by collecting functional magnetic resonance imaging data during cannabis cue administration before and after the treatment course (Aim 2). These aims will be addressed through a nine-week, double-blind, randomized, sham-controlled study in which 72 treatment-seeking cannabis use disordered participants (36/group) will be given 20 sessions of either Active or Sham excitatory rTMS applied to the DLPFC. rTMS will be delivered over five weeks (2 sessions each day, two days each week). rTMS will be applied in conjunction with a validated three-session Motivational Enhancement Therapy (MET) behavioral intervention.

Eligibility criteria: Inclusion Criteria:

1. Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
2. Participants must be between the ages of 18 and 60.
3. Participants must meet DSM-5 criteria for at least moderate Cannabis Use Disorder, with use of at least 20 out of the last 28 days.
4. Participants must express a desire to quit cannabis.
5. Participants must have a Positive UDS for cannabis during their baseline visit (confirming they are regular users).

Exclusion Criteria:

1. Participants must not be pregnant or breastfeeding.
2. Participants must not meet moderate or severe use disorder of any other substance with the exception of Nicotine Use Disorder.
3. Participants must not be on any medications that have central nervous system effects.
4. Participants must not have a history of/or current psychotic disorder or bipolar disorder.
5. Participants must not have any other Axis I condition requiring current treatment and must have a HRSD24 ≤10 indicating no clinically relevant depressive symptoms.
6. Participants must not have a history of Dementia or other cognitive impairment.
7. Participants must not have active suicidal ideation, or a suicide attempt within the past 90 days.
8. Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the head, history of seizure, any known brain lesion).
9. Participants must not have any unstable general medical conditions.

Primary outcomes:
measure: Marijuana Craving Questionnaire-Short Form Score as a Measure of Behavioral Craving
timeFrame: Baseline (pre) and Week-5 (post)
measure: Cue Reactivity
timeFrame: Baseline (pre) and Week-5 (post)
Secondary outcomes:
measure: Abstinence
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Gregory Sahlem, MD
role: PRINCIPAL_INVESTIGATOR
References: