Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder (NCT NCT03538444)
NCT ID: NCT03538444
Last Updated: 2022-02-14
Results Overview
Change in cue-induced craving ratings on 10 point Likert Scales. 0=Not at all; 10=Extremely How much do you WANT TO USE \_(opiate of choice)\_ right now? HOW HARD would it be for you TO RESIST USING\_(opiate of choice)\_ right now if it was offered to you? How much do you currently crave opiates? (scores on each of those questions are summed to be between 0 and 30 with 30 being the highest (and indicating the most craving).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline and three days: Pre-assessment (day 1-prior to the first delivered rTMS treatment) compared to post assessment (AM of day4 the morning following the final of three days of rTMS)
Results posted on
2022-02-14
Participant Flow
Participant milestones
| Measure |
Active rTMS
Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method
Repetitive Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder
|
Sham rTMS
Participants will receive 18 sessions of sham rTMS over a period of three days.
Sham rTMS: Participants will undergo procedures that mimic rTMS, but that are inactive.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Active rTMS
Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method
Repetitive Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder
|
Sham rTMS
Participants will receive 18 sessions of sham rTMS over a period of three days.
Sham rTMS: Participants will undergo procedures that mimic rTMS, but that are inactive.
|
|---|---|---|
|
Overall Study
opioid withdrawal
|
1
|
0
|
Baseline Characteristics
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
Baseline characteristics by cohort
| Measure |
Active rTMS
n=4 Participants
Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method
Repetitive Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder
|
Sham rTMS
n=3 Participants
Participants will receive 18 sessions of sham rTMS over a period of three days.
Sham rTMS: Participants will undergo procedures that mimic rTMS, but that are inactive.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 2 • n=5 Participants
|
36 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 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
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Composite Provoked Opioid Craving 0-30 likert scale (sum of 0-10 each for want, resist, crave)
|
11 units on a scale, higher -> more craving
STANDARD_DEVIATION 6.9 • n=5 Participants
|
23.7 units on a scale, higher -> more craving
STANDARD_DEVIATION 8.5 • n=7 Participants
|
19.1 units on a scale, higher -> more craving
STANDARD_DEVIATION 10.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and three days: Pre-assessment (day 1-prior to the first delivered rTMS treatment) compared to post assessment (AM of day4 the morning following the final of three days of rTMS)Change in cue-induced craving ratings on 10 point Likert Scales. 0=Not at all; 10=Extremely How much do you WANT TO USE \_(opiate of choice)\_ right now? HOW HARD would it be for you TO RESIST USING\_(opiate of choice)\_ right now if it was offered to you? How much do you currently crave opiates? (scores on each of those questions are summed to be between 0 and 30 with 30 being the highest (and indicating the most craving).
Outcome measures
| Measure |
Active rTMS
n=3 Participants
Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method
Repetitive Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder
|
Sham rTMS
n=3 Participants
Participants will receive 18 sessions of sham rTMS over a period of three days.
Sham rTMS: Participants will undergo procedures that mimic rTMS, but that are inactive.
|
|---|---|---|
|
Composite Opioid Craving (Want, Resist, Crave)
|
0.7 units on a scale
Standard Deviation 1.2
|
16.7 units on a scale
Standard Deviation 12.7
|
Adverse Events
Active rTMS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham rTMS
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 |
Active rTMS
n=4 participants at risk
Participants will receive 18 sessions of active repetitive Transcranial Magnetic Stimulation over a period of three days. TMS consists of 3000 pulses of 10Hz stimulation applied to the left DLPFC using the beam F3 method
Repetitive Transcranial Magnetic Stimulation: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder
|
Sham rTMS
n=3 participants at risk
Participants will receive 18 sessions of sham rTMS over a period of three days.
Sham rTMS: Participants will undergo procedures that mimic rTMS, but that are inactive.
|
|---|---|---|
|
Nervous system disorders
headache
|
25.0%
1/4 • Number of events 1 • 1-month
As per clinicaltrials.gov definitions
|
0.00%
0/3 • 1-month
As per clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place