Trial Outcomes & Findings for Investigating Two rTMS Strategies to Treat Cannabis Use Disorder (NCT NCT05720312)
NCT ID: NCT05720312
Last Updated: 2025-05-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
6 to 9 weeks
Results posted on
2025-05-28
Participant Flow
Participants receive 6 to 9 weeks of active treatment, then enter a 7 week follow-up period, from the last treatment (up to 1 week) plus 6 weeks post-treatment.
22 participants signed informed consent, and 20 were randomized to treatment.
Participant milestones
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
36 sessions of high frequency (10Hz) repetitive Transcranial Magnetic Stimulation (rTMS).
|
Ventromedial Prefrontal Cortex (vmPFC)
36 sessions of low frequency (1Hz) rTMS.
|
|---|---|---|
|
Treatment Period (6 to 9 Weeks)
STARTED
|
10
|
10
|
|
Treatment Period (6 to 9 Weeks)
COMPLETED
|
8
|
8
|
|
Treatment Period (6 to 9 Weeks)
NOT COMPLETED
|
2
|
2
|
|
Follow-up Period (6 Weeks)
STARTED
|
8
|
8
|
|
Follow-up Period (6 Weeks)
COMPLETED
|
6
|
8
|
|
Follow-up Period (6 Weeks)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigating Two rTMS Strategies to Treat Cannabis Use Disorder
Baseline characteristics by cohort
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=10 Participants
36 sessions of high frequency (10Hz) rTMS.
|
Ventromedial Prefrontal Cortex (vmPFC)
n=10 Participants
36 sessions of low frequency (1Hz) rTMS.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 to 9 weeksOutcome measures
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=10 Participants
36 sessions of high frequency (10Hz) rTMS.
|
Ventromedial Prefrontal Cortex (vmPFC)
n=10 Participants
36 sessions of low frequency (1Hz) rTMS.
|
|---|---|---|
|
Number (%) of Participants Who Started and Completed Treatment
|
8 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day 1 (90 minutes to complete scan)Outcome measures
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=10 Participants
36 sessions of high frequency (10Hz) rTMS.
|
Ventromedial Prefrontal Cortex (vmPFC)
n=10 Participants
36 sessions of low frequency (1Hz) rTMS.
|
|---|---|---|
|
Number (%) of Participants Who Had Successful Generation of Functional Magnetic Resonance Imaging (fMRI) Targets
|
10 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 13 weeks (final 7 weeks of active treatment plus 6-week post-treatment follow-up)Number (%) of weeks where the participant does not use any cannabis.
Outcome measures
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=130 patient weeks
36 sessions of high frequency (10Hz) rTMS.
|
Ventromedial Prefrontal Cortex (vmPFC)
n=130 patient weeks
36 sessions of low frequency (1Hz) rTMS.
|
|---|---|---|
|
Number (%) Weeks of Abstinence From Cannabis
|
0 patient weeks
|
56 patient weeks
|
SECONDARY outcome
Timeframe: 4 weeks prior to baseline assessment and 7 weeks at the end of treatment through 6-week post-treatment follow-upNumber of days per week (0-7) where the participant uses any cannabis. At the time of enrollment participants were asked to recall the number of days of cannabis use per week for the 4 weeks prior to enrollment. Participants were then asked (over a period of 7 weeks) to recall days of use at the last fMRI visit (during prior week) and at the week 2, 4, and 6 follow-up visits. Average values are reported for the 4-week period prior to enrollment and the 7-week period at end of treatment at follow-up.
Outcome measures
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=10 Participants
36 sessions of high frequency (10Hz) rTMS.
|
Ventromedial Prefrontal Cortex (vmPFC)
n=10 Participants
36 sessions of low frequency (1Hz) rTMS.
|
|---|---|---|
|
Number of Days of Use Per Week.
Baseline assessment
|
6.82 days per week
Standard Deviation 0.38
|
6.68 days per week
Standard Deviation 0.69
|
|
Number of Days of Use Per Week.
End of treatment / Follow-up
|
5.27 days per week
Standard Deviation 1.95
|
2.82 days per week
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: 4 weeks prior to baseline assessment and 7 weeks at the end of treatment through 6-week post-treatment follow-upNumber of use sessions per week where the participant uses any cannabis. At the time of enrollment participants were asked to recall the number of cannabis use sessions per week for the 4 weeks prior to enrollment. Participants were then asked (over a period of 7 weeks) to recall the number of cannabis use sessions at the last fMRI visit (during prior week) and at the week 2, 4, and 6 follow-up visits. Average values are reported for the 4-week period prior to enrollment and the 7-week period at end of treatment at follow-up.
Outcome measures
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=10 Participants
36 sessions of high frequency (10Hz) rTMS.
|
Ventromedial Prefrontal Cortex (vmPFC)
n=10 Participants
36 sessions of low frequency (1Hz) rTMS.
|
|---|---|---|
|
Average Number of Use Sessions Per Week.
Baseline assessment
|
50.33 use sessions per week
Standard Deviation 27.28
|
32.55 use sessions per week
Standard Deviation 18.52
|
|
Average Number of Use Sessions Per Week.
End of treatment / Follow-up
|
29.68 use sessions per week
Standard Deviation 27.26
|
11.69 use sessions per week
Standard Deviation 18.71
|
SECONDARY outcome
Timeframe: Baseline and end of the follow-up period (12 to 15 weeks post-baseline)The Q-LES-Q-SF overall score range is from 14 to 70, with higher scores indicating greater satisfaction and enjoyment. The total score is expressed as a percentage of the maximum possible score (1-100).
Outcome measures
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=10 Participants
36 sessions of high frequency (10Hz) rTMS.
|
Ventromedial Prefrontal Cortex (vmPFC)
n=10 Participants
36 sessions of low frequency (1Hz) rTMS.
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Scale Score
Baseline assessment
|
56.25 score on a scale
Standard Deviation 13.61
|
54.82 score on a scale
Standard Deviation 11.97
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Scale Score
End 6-week follow-up
|
62.50 score on a scale
Standard Deviation 11.01
|
67.63 score on a scale
Standard Deviation 11.15
|
SECONDARY outcome
Timeframe: Follow-up period (final week of active treatment plus 6-week post-treatment follow-up)Based on patient self-report of any 4-week period of abstinence
Outcome measures
| Measure |
Dorsolateral Prefrontal Cortex (DLPFC)
n=10 Participants
36 sessions of high frequency (10Hz) rTMS.
|
Ventromedial Prefrontal Cortex (vmPFC)
n=10 Participants
36 sessions of low frequency (1Hz) rTMS.
|
|---|---|---|
|
Number of Participants Who Had a Period of 4-consecutive Weeks of Abstinence During the Follow-up Period
|
0 Participants
|
4 Participants
|
Adverse Events
DLPFC - Treatment Period
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
vmPFC - Treatment Period
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DLPFC - Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
vmPFC - Follow-up Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DLPFC - Treatment Period
n=10 participants at risk
36 sessions of high frequency (10Hz) rTMS.
|
vmPFC - Treatment Period
n=10 participants at risk
36 sessions of low frequency (1Hz) rTMS.
|
DLPFC - Follow-up Period
n=8 participants at risk
36 sessions of high frequency (10Hz) rTMS.
|
vmPFC - Follow-up Period
n=8 participants at risk
36 sessions of low frequency (1Hz) rTMS.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
20.0%
2/10 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
10.0%
1/10 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
0.00%
0/8 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
0.00%
0/8 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
20.0%
2/10 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
0.00%
0/8 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
0.00%
0/8 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
|
Eye disorders
Transient Vision Change
|
0.00%
0/10 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
10.0%
1/10 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
0.00%
0/8 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
0.00%
0/8 • Up to 15 weeks (6 to 9 weeks of treatment plus 6 week follow up)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place