Trial Outcomes & Findings for Pilot TMS for Methamphetamine Use Disorder (NCT NCT04449055)
NCT ID: NCT04449055
Last Updated: 2026-01-16
Results Overview
Time to discontinuation of psychosocial treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Baseline to 18 days (continuous--assessed weekly)
Results posted on
2026-01-16
Participant Flow
Participant milestones
| Measure |
DPFC First
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
DPFC First
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Missed 4 treatments--removed by PI
|
1
|
1
|
|
Overall Study
Could not refrain from methamphetamine for 24 hours before treatment--removed by PI
|
1
|
0
|
|
Overall Study
Incarcerated
|
1
|
0
|
Baseline Characteristics
Pilot TMS for Methamphetamine Use Disorder
Baseline characteristics by cohort
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 10.9 • n=9 Participants
|
39.6 years
STANDARD_DEVIATION 10.5 • n=6 Participants
|
38.5 years
STANDARD_DEVIATION 10.2 • n=9 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=9 Participants
|
5 participants
n=6 Participants
|
11 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks (continuous)Population: Participants who received at least one treatment.
Time to study dropout (to assess feasibility and tolerability of the protocol)
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Retention in the Study
|
28.2 Days
Standard Error 9.4
|
45.4 Days
Standard Error 13.4
|
PRIMARY outcome
Timeframe: Baseline to 18 days (continuous--assessed weekly)Population: Those randomized with complete data on continuation of psychosocial treatment for methamphetamine use disorder. Missing data due to a collection form error led to no information after 18 days, and information was not entered for some participants at earlier visits.
Time to discontinuation of psychosocial treatment
Outcome measures
| Measure |
DPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=4 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Retention in Psychosocial Treatment
|
NA Days until discontinuation
Median survival times were not estimable due to too few events
|
NA Days until discontinuation
Median survival times were not estimable due to too few events
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Participants with MRI data for both baseline and after 4 weeks of treatment.
Functional connectivity of the dorsolateral prefrontal cortex and anterior insula (mean of left and right side connectivity) measured with fMRI, as defined by the temporal correlation in the blood-oxygen-level-dependent signals of the regions. Higher correlations indicate stronger functional connectivity.
Outcome measures
| Measure |
DPFC First
n=2 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=4 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Functional Connectivity of the Dorsolateral Prefrontal Cortex and Anterior Insula
Temporal correlation between regions at baseline
|
-0.0437533 Pearson correlation (r)
Standard Deviation 0.0404869
|
0.000470725 Pearson correlation (r)
Standard Deviation 0.1561368
|
|
Functional Connectivity of the Dorsolateral Prefrontal Cortex and Anterior Insula
Temporal correlation between regions after 4-week intervention
|
0.0844848 Pearson correlation (r)
Standard Deviation 0.0315233
|
0.0129312 Pearson correlation (r)
Standard Deviation 0.0308713
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Participants with MRI data for both baseline and after 4 weeks of treatment.
Functional connectivity of the left dorsolateral prefrontal cortex and left dorsal anterior cingulate cortex measured with fMRI, as defined by the temporal correlation in the blood-oxygen-level-dependent signals of the regions. Higher correlations indicate stronger functional connectivity.
Outcome measures
| Measure |
DPFC First
n=2 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=4 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Functional Connectivity Dorsolateral Prefrontal Cortex and Anterior Cingulate Cortex
Correlation between regions at baseline
|
-0.0563551 Pearson correlation (r)
Standard Deviation 0.0759435
|
0.0542240 Pearson correlation (r)
Standard Deviation 0.0749761
|
|
Functional Connectivity Dorsolateral Prefrontal Cortex and Anterior Cingulate Cortex
Correlation between regions after 4-week intervention
|
-0.2974375 Pearson correlation (r)
Standard Deviation 0.2386470
|
0.0960170 Pearson correlation (r)
Standard Deviation 0.1248435
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Participants with MRI data for both baseline and after 4 weeks of treatment.
Functional connectivity of the left medial prefrontal cortex and ventral striatum (mean of medial prefrontal cortex connectivity to left and right nucleus accumbens) measured with fMRI, as defined by the temporal correlation in the blood-oxygen-level-dependent signals of the regions. Higher correlations indicate stronger functional connectivity.
Outcome measures
| Measure |
DPFC First
n=2 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=4 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Functional Connectivity of the Medial Prefrontal Cortex and Ventral Striatum (Nucleus Accumbens)
Correlation between regions at baseline
|
0.1795790 Pearson correlation (r)
Standard Deviation 0.0957911
|
0.0383048 Pearson correlation (r)
Standard Deviation 0.1329478
|
|
Functional Connectivity of the Medial Prefrontal Cortex and Ventral Striatum (Nucleus Accumbens)
Correlation between regions after 4-week intervention
|
-0.0576222 Pearson correlation (r)
Standard Deviation 0.1671134
|
0.0474714 Pearson correlation (r)
Standard Deviation 0.1695334
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Those who had a flanker test at baseline and at 4 weeks (stayed in the study through all TMS treatments).
Summary score of accuracy and reaction time. Higher scores indicate stronger inhibitory control and attention (better ability to attend to relevant stimuli and block out irrelevant stimuli). The reported scores are age-corrected standard scores, which have a population mean of 100 and standard deviation of 15. Means are estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=2 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=3 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Flanker Inhibitor Control and Attention Test, Age 12+
Baseline
|
115 age-corrected standard score
Standard Error 6
|
97 age-corrected standard score
Standard Error 5
|
|
Flanker Inhibitor Control and Attention Test, Age 12+
4 weeks
|
106 age-corrected standard score
Standard Error 6
|
93 age-corrected standard score
Standard Error 5
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Those with a measure at baseline and 4 weeks.
Summary score of discounting rate. Scores range from 0.00016 to 0.5, with smaller values indicating a lack of discounting and preference for delayed rewards, and higher values indicating strong discounting and preference for immediate rewards. Higher scores are associated with addictive behaviors. The log of K is reported due to its skewed nature. Values are estimated from a mixed model.
Outcome measures
| Measure |
DPFC First
n=2 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=3 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Kirby Delay Discounting Questionnaire, 27 Item
Baseline
|
-2.9817 Log of overall K
Standard Error 1.1013
|
-3.8350 Log of overall K
Standard Error 0.8992
|
|
Kirby Delay Discounting Questionnaire, 27 Item
4 weeks
|
-2.7660 Log of overall K
Standard Error 1.1013
|
-3.9792 Log of overall K
Standard Error 0.8992
|
SECONDARY outcome
Timeframe: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 8 weeks, 12 weeksPopulation: All participants who were randomized/received at least one treatment
Estimated change per day in number of days of stimulant use in the last week (self-reported) from mixed models. Measured as number of days of methamphetamine use because methamphetamine and other stimulant use were reported separately, and it was not clear if these were on the same or different days. The vast majority of subjects reported using only methamphetamine.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Number of Days of Stimulant Use in the Past Week (Estimated Change Per Day)
|
-0.1026 Days of use in last week-change per day
Standard Error 0.04322
|
-0.09523 Days of use in last week-change per day
Standard Error 0.04523
|
SECONDARY outcome
Timeframe: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeksPopulation: All participants who were randomized/received at least one treatment.
Urine dipstick positive or not for stimulants (amphetamine, methamphetamine, cocaine)
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Urine Drug Screen Positive for Stimulant
|
0.8892 odds ratio for positive per day in study
Interval 0.7687 to 1.0286
|
0.9921 odds ratio for positive per day in study
Interval 0.977 to 1.0074
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Those randomized (who received at least one treatment).
The Brief Substance Craving Scale Score used was the summary score of intensity, frequency and length of cravings in the last 24 hours. Scores based on stimulant craving responses and range from 0-12 with higher scores indicating more craving. Scores are least squared means from mixed models of actual measures, without last observation carried forward or any imputation. Change in score per day estimated from a mixed model.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Brief Substance Craving Scale (Estimated Change in Score Per Day)
|
-0.04980 Estimated change in score per day
Standard Error 0.02369
|
-0.02411 Estimated change in score per day
Standard Error 0.01781
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeksPopulation: Those who were randomized and received at least one treatment
Use subscale. Scores range from 0 to 12 with higher scores indicating more use. Outcome measures reported as change per day estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Brief Addiction Monitor Use Subscale (Estimated Change in Score Per Day)
|
-0.05848 Estimated change in scores per day
Standard Error 0.01532
|
-0.04089 Estimated change in scores per day
Standard Error 0.01204
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeksPopulation: Those who were randomized/received at least one treatment
Risk factors subscale. Scores range from 0 to 24 with higher scores indicating more risk. Results presented as change in score per day estimated from a mixed model.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Brief Addiction Monitor Risk Factors Subscale (Estimated Change in Score Per Day)
|
-0.1235 Estimated change in score per day
Standard Error 0.04053
|
-0.1066 Estimated change in score per day
Standard Error 0.03568
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeksPopulation: Those randomized/received at least one treatment with complete BAM protective factors data at one or more time points
Protective factors subscale. Scores range from 0 to 24 with higher scores indicating more protection. Change in score per day estimated from mixed model.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=4 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Brief Addiction Monitor Protective Factors Subscale (Estimated Change in Score Per Day)
|
-0.00530 Estimated change in score per day
Standard Error 0.03623
|
0.03826 Estimated change in score per day
Standard Error 0.03155
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeksPopulation: Those who were randomized/received at least one treatment and had a baseline score for question 17 on the Brief Addiction Monitor.
Item 17, satisfaction with progress toward achieving recovery goals. Scores range from 0 to 4 with higher scores indicating less satisfaction. Reported as change per day estimated from a mixed model.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Brief Addiction Monitor Satisfaction With Progress Toward Achieving Recovery Goals (Estimated Change Per Day)
|
-0.01378 Estimated change in score per day
Standard Error 0.01300
|
-0.00833 Estimated change in score per day
Standard Error 0.01003
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeksPopulation: All those who were randomized/received at least one treatment and had complete baseline data for QLES.
Total score. Scores range from 16 to 80 with higher scores indicating more satisfaction. Scores generally reported as a percent of the maximum possible score, such that scores can be calculated with missing responses as long as less than one-third of responses are missing. This outcome measure is reported as change in score per day estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Estimated Change in Score Per Day)
|
0.003497 Estimated change in score per day
Standard Error 0.09139
|
0.2160 Estimated change in score per day
Standard Error 0.07123
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeksPopulation: All who were randomized/received at least one treatment
Total score. Scores range from 0 to 24 with higher scores indicating worse depressive symptoms. This outcome measure is reported as change in score per day estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Patient Health Questionnaire--8 Item Scale (Estimated Change in Score Per Day)
|
-0.08549 Estimated change in score per day
Standard Error 0.05749
|
-0.1328 Estimated change in score per day
Standard Error 0.0098
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeksPopulation: All participants who were randomized/received at least one treatment
Total score. Scores range from 0 to 21 with higher scores indicating worse anxiety. This outcome measure is reported as change in score per day estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Generalized Anxiety Disorder 7-item Scale (Estimated Change Per Day)
|
-0.05545 Estimated change in score per day
Standard Error 0.05014
|
-0.05776 Estimated change in score per day
Standard Error 0.03911
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeksPopulation: All participants who were randomized/received at least one treatment.
Total score. Scores range from 0 to 50 with higher scores indicating greater recovery capital. This outcome measure is reported as change in score per day estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Assessment of Recovery Capital (Estimated Change Per Day)
|
0.09980 Estimated change in score per day
Standard Error 0.09175
|
0.2266 Estimated change in score per day
Standard Error 0.06983
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeksPopulation: All participants who were randomized/received at least one treatment
Positive affect score. Scores range from 10 to 50 with higher scores indicating higher positive affect. Higher positive affect is a better outcome. This outcome measure is reported as change in score per day estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Positive and Negative Affect Scale Positive Affect Score (Estimated Change Per Day)
|
-0.04983 Estimated change in score per day
Standard Error 0.06358
|
0.1111 Estimated change in score per day
Standard Error 0.04856
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeksPopulation: All participants randomized/received at least one treatment who had complete PANAS negative affect data at baseline
Negative affect score. Scores range from 10 to 50 with lower scores indicating lower negative affect. Lower negative affect is a better outcome. This outcome measure is reported as change in score per day estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Positive and Negative Affect Scale Negative Affect Score (Estimated Change Per Day)
|
-0.08496 Estimated change in score per day
Standard Error 0.06962
|
-0.07669 Estimated change in score per day
Standard Error 0.05177
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeksPopulation: All who were randomized/received at least one treatment
Total score. Scores range from 0 to 21, with lower scores indicating better sleep quality. This outcome measure is reported as change in score per day estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (Estimated Change Per Day)
|
-0.08000 Estimated change in score per day
Standard Error 0.02111
|
-0.07924 Estimated change in score per day
Standard Error 0.01649
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: All participants who were randomized/received at least one treatment
Total score. Scores range from 18 to 90 with higher values indicating more difficulty with emotional regulation. This outcome measure is reported as change in score per day estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Difficulties in Emotion Regulation Scale--Short Form (Estimated Change Per Day)
|
-0.1035 Estimated change in score per day
Standard Error 0.02083
|
-0.1010 Estimated change in score per day
Standard Error 0.01416
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: All participants who were randomized/received at least one treatment
Summary score. Scores range from 59 to 236 with higher scores indicating more impulsive behavior. This outcome measure is reported as change in score per day estimated from mixed models.
Outcome measures
| Measure |
DPFC First
n=6 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 Participants
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
UPPS-P Impulsive Behavior Scale, 59-item Revised Version (Estimated Change Per Day)
|
0.06023 Estimated change in score per day
Standard Error 0.8642
|
-0.2392 Estimated change in score per day
Standard Error 0.2670
|
Adverse Events
DPFC First
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
MPFC First
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DPFC First
n=6 participants at risk
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 participants at risk
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
16.7%
1/6 • Number of events 1 • 4 weeks, while engaged in TMS treatment.
The only serious adverse event did not arise during a treatment session. It could not be specifically attributed to DPFC stimulation versus MPFC stimulation since participants received both at each treatment session, with groups only differentiated by the order in which they received stimulation within each treatment session.
|
0.00%
0/5 • 4 weeks, while engaged in TMS treatment.
The only serious adverse event did not arise during a treatment session. It could not be specifically attributed to DPFC stimulation versus MPFC stimulation since participants received both at each treatment session, with groups only differentiated by the order in which they received stimulation within each treatment session.
|
Other adverse events
| Measure |
DPFC First
n=6 participants at risk
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the dorsolateral prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
MPFC First
n=5 participants at risk
Participants in this arm will undergo all study procedures including consent; pre-, during, and post-psychological assessments; pre- and post- MRI and fMRI; 16 treatments of dual target TMS over a 4-week period; and substance use-related assessments to include substance use, withdrawal symptoms, and cravings to use. This arm will receive the medial prefrontal cortex stimulation first.
Transcranial Magnetic Stimulation: Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
|
|---|---|---|
|
Nervous system disorders
Headache (mild)
|
33.3%
2/6 • Number of events 6 • 4 weeks, while engaged in TMS treatment.
The only serious adverse event did not arise during a treatment session. It could not be specifically attributed to DPFC stimulation versus MPFC stimulation since participants received both at each treatment session, with groups only differentiated by the order in which they received stimulation within each treatment session.
|
0.00%
0/5 • 4 weeks, while engaged in TMS treatment.
The only serious adverse event did not arise during a treatment session. It could not be specifically attributed to DPFC stimulation versus MPFC stimulation since participants received both at each treatment session, with groups only differentiated by the order in which they received stimulation within each treatment session.
|
|
Nervous system disorders
Pain
|
33.3%
2/6 • Number of events 2 • 4 weeks, while engaged in TMS treatment.
The only serious adverse event did not arise during a treatment session. It could not be specifically attributed to DPFC stimulation versus MPFC stimulation since participants received both at each treatment session, with groups only differentiated by the order in which they received stimulation within each treatment session.
|
0.00%
0/5 • 4 weeks, while engaged in TMS treatment.
The only serious adverse event did not arise during a treatment session. It could not be specifically attributed to DPFC stimulation versus MPFC stimulation since participants received both at each treatment session, with groups only differentiated by the order in which they received stimulation within each treatment session.
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/6 • 4 weeks, while engaged in TMS treatment.
The only serious adverse event did not arise during a treatment session. It could not be specifically attributed to DPFC stimulation versus MPFC stimulation since participants received both at each treatment session, with groups only differentiated by the order in which they received stimulation within each treatment session.
|
20.0%
1/5 • Number of events 1 • 4 weeks, while engaged in TMS treatment.
The only serious adverse event did not arise during a treatment session. It could not be specifically attributed to DPFC stimulation versus MPFC stimulation since participants received both at each treatment session, with groups only differentiated by the order in which they received stimulation within each treatment session.
|
Additional Information
Dr. Ryan Carnahan
The University of Iowa College of Public Health
Phone: 3193841556
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place