Trial Outcomes & Findings for A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder (NCT NCT03144232)

Last Updated: 2023-08-09

Results Overview

The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced level of behavioral cannabis craving prior to their final rTMS session as compared to prior to their first rTMS session. The investigators will measure behavioral cannabis craving using the marijuana craving questionnaire. Score range: 12 to 84, higher scores represent more craving.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Baseline (pre) and Week-5 (post)

Results posted on

2023-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Repetitive Transcranial Magnetic Stimulation (rTMS) 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (DLPFC).	Sham rTMS Sham rTMS applied to the left DLPFC.
Overall Study STARTED	37	35
Overall Study COMPLETED	28	23
Overall Study NOT COMPLETED	9	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Preliminary Investigation of Pre-Frontal Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Cannabis Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Repetitive Transcranial Magnetic Stimulation (rTMS) n=37 Participants 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (DLPFC).	Sham rTMS n=35 Participants Sham rTMS applied to the left DLPFC.	Total n=72 Participants Total of all reporting groups
Age, Continuous	29.8 years STANDARD_DEVIATION 9.9 • n=5 Participants	30.7 years STANDARD_DEVIATION 10.0 • n=7 Participants	30.2 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre) and Week-5 (post)

Population: All participants were included in the analysis using a mixed model, but the post-treatment mean and standard deviation only included available data (participants who completed treatment).

Outcome measures

Outcome measures
Measure	Repetitive Transcranial Magnetic Stimulation (rTMS) n=37 Participants 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (DLPFC).	Sham rTMS n=35 Participants Sham rTMS applied to the left DLPFC.
Marijuana Craving Questionnaire-Short Form Score as a Measure of Behavioral Craving Pre	45.8 score on a scale Standard Deviation 18.5	45.2 score on a scale Standard Deviation 16.3
Marijuana Craving Questionnaire-Short Form Score as a Measure of Behavioral Craving Post	27.7 score on a scale Standard Deviation 15.1	22.6 score on a scale Standard Deviation 11.1

PRIMARY outcome

Timeframe: Baseline (pre) and Week-5 (post)

Population: Participants with data at both pre and post time-points were included in the analysis.

The investigators hypothesize that as compared to those participants receiving sham rTMS, those participants receiving active rTMS will have a reduced BOLD response in reward structures (dorsal striatum, ventral striatum, and anterior consulate cortex) during a validated cue-reactivity fMRI paradigm prior to their final rTMS session as compared to prior to their first rTMS session (change score). The following beta scores represent the change score (post-pre) in scans in the drug stimuli minus neutral stimuli subtraction map. Generally, more activation (a positive score) represents more cannabis image cue-reactivity, and the reported range represents standard units as output in the fMRI.

Outcome measures

Outcome measures
Measure	Repetitive Transcranial Magnetic Stimulation (rTMS) n=23 Participants 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (DLPFC).	Sham rTMS n=17 Participants Sham rTMS applied to the left DLPFC.
Cue Reactivity Ventral Striatum	0.010 BOLD signal change Standard Deviation 0.164	-0.025 BOLD signal change Standard Deviation 0.138
Cue Reactivity Dorsal Striatum	-0.013 BOLD signal change Standard Deviation 0.106	-0.022 BOLD signal change Standard Deviation 0.122
Cue Reactivity Anterior Cingulate Cortex	0.003 BOLD signal change Standard Deviation 0.167	-0.015 BOLD signal change Standard Deviation 0.125

SECONDARY outcome

Timeframe: 4-weeks

Number of weeks (out of a total of 4 possible), in the follow-up period, where participants were abstinent from cannabis. Missing data was conservatively assumed to be non-abstinant. More weeks of abstinence is more favourable

Outcome measures

Outcome measures
Measure	Repetitive Transcranial Magnetic Stimulation (rTMS) n=37 Participants 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (DLPFC).	Sham rTMS n=35 Participants Sham rTMS applied to the left DLPFC.
Abstinence	.62 weeks Standard Deviation 1.21	.37 weeks Standard Deviation .77

Adverse Events

Repetitive Transcranial Magnetic Stimulation (rTMS)

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Sham rTMS

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Repetitive Transcranial Magnetic Stimulation (rTMS) n=37 participants at risk 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (DLPFC).	Sham rTMS n=35 participants at risk Sham rTMS applied to the left DLPFC.
Nervous system disorders Headache	27.0% 10/37 • 9-weeks	11.4% 4/35 • 9-weeks
Nervous system disorders Fatigue	16.2% 6/37 • 9-weeks	8.6% 3/35 • 9-weeks
Eye disorders Eye twitch	2.7% 1/37 • 9-weeks	0.00% 0/35 • 9-weeks
Musculoskeletal and connective tissue disorders Jaw Pain	2.7% 1/37 • 9-weeks	0.00% 0/35 • 9-weeks
Nervous system disorders Site discomfort	2.7% 1/37 • 9-weeks	0.00% 0/35 • 9-weeks
Psychiatric disorders Insomnia	0.00% 0/37 • 9-weeks	2.9% 1/35 • 9-weeks
Psychiatric disorders Mood Swings	0.00% 0/37 • 9-weeks	2.9% 1/35 • 9-weeks
Nervous system disorders Hand numbness	0.00% 0/37 • 9-weeks	2.9% 1/35 • 9-weeks
Psychiatric disorders Anxiety	0.00% 0/37 • 9-weeks	2.9% 1/35 • 9-weeks

Additional Information

Gregory Sahlem

Stanford University

Phone: 650-724-0444

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place