An interventional study of tDCS and sham tDCS in Opioid Dependence and Craving, sponsored by Butler Hospital. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment
In the current proposal, the investigators will measure behavioral and brain responses following transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (DLPFC) (anode on right DLPFC, cathode on the left DLPFC) delivered during cognitive control network (CCN) priming. Participants with opioid dependence, in the first month of prescribed buprenorphine or methadone, will be assessed twice using electroencephalographic (EEG), once prior to tDCS+CCN priming and again at the completion of 5 sessions of tDCS+CCN priming (one week later). EEG will provide validation of expected changes in these networks following tDCS stimulation of the DLPFC.
Investigators propose to use EEG to examine oscillatory brain changes as well as self-reported craving before and after administration of five sessions of tDCS+Cognitive Control Network (CCN) priming stimulation vs. sham tDCS+CCN priming (randomized control trial) in 60 opioid dependent participants who recently initiated buprenorphine or methadone. Participants in the first month of prescribed buprenorphine or methadone will be assessed EEG, once prior to tDCS and again one week later after completion of 5 sessions of tDCS+CCN priming. EEG will be expected to provide 1) validation of expected network and oscillatory changes from tDCS-targeting and 2) an effect size for DLPFC vs sham stimulation. Go/no go criteria for the UG3 phase will be demonstration of enhanced frontal theta power during a WM task AND greater change (at least 10% difference between conditions, controlling for baseline craving) in subjective craving following the tDCS+CCN priming intervention compared to sham tDCS+CCN priming.
1,439 studies on the registry are indexed under Opioid-Related Disorders; 291 are open to participants now.
This study's enrollment of 62 is close to the median of 62 across 1,145 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Butler Hospital is the lead sponsor of 118 studies on the registry; 13 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
Device: tDCS
Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
Device: sham tDCS
Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
Opioid Craving
Penn Alcohol Craving (Modified for Opioids). This is a 5-item measure, with each item scored 0 to 6. Items are summed for a total score from 0 to 30. Higher scores = more craving.
Time frame: 2 week
EEG Theta Brainwave Activity
Theta event rate is examined as the number of times/second that brainwaves within the theta frequency range (4-7 Hz). Higher event rates reflect more activity during working memory task.
Time frame: 2 weeks
Participant recruitment started June 4, 2019 and was completed on 2/21/23. Participants were recruited from both clinical settings and through community advertisements.
| Milestone | tDCS | Sham tDCS |
|---|---|---|
| Started | 27 | 27 |
| Completed | 26 | 25 |
| Not completed | 1 | 2 |
Penn Alcohol Craving (Modified for Opioids). This is a 5-item measure, with each item scored 0 to 6. Items are summed for a total score from 0 to 30. Higher scores = more craving.
| units on a scale | tDCS | Sham tDCS |
|---|---|---|
| Opioid Craving | 8.92 ± 1.10 | 8.32 ± 1.12 |
Theta event rate is examined as the number of times/second that brainwaves within the theta frequency range (4-7 Hz). Higher event rates reflect more activity during working memory task.
| events per second | tDCS | Sham tDCS |
|---|---|---|
| EEG Theta Brainwave Activity | .38 ± .06 | .33 ± .05 |
Collected over 2-weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| tDCS | 0/27 (0%) | 0/27 (0%) | 1/27 (3.7%) |
| Sham tDCS | 0/27 (0%) | 0/27 (0%) | 2/27 (7.4%) |
| Event | tDCS | Sham tDCS |
|---|---|---|
| NauseaGastrointestinal disorders | 0/27 | 1/27 |
| HeadacheGeneral disorders | 0/27 | 1/27 |
| Head ItchinessSkin and subcutaneous tissue disorders | 1/27 | 0/27 |
N=62 participants completed baselines and were enrolled in the study. Of these, n=8 were never randomized due to randomization occurring on the day of the first stimulation session.
| Age, Continuous(years) | tDCS | Sham tDCS | Not Randomized | Total |
|---|---|---|---|---|
| Mean | 33.19 ± 7.44 | 34.48 ± 7.91 | 35.75 ± 10.38 | 34.08 ± 7.96 |
| Sex: Female, Male(Participants) | tDCS | Sham tDCS | Not Randomized | Total |
|---|---|---|---|---|
| Female | 9 | 14 | 2 | 25 |
| Male | 18 | 13 | 6 | 37 |
| Ethnicity (NIH/OMB)(Participants) | tDCS | Sham tDCS | Not Randomized | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 3 | 0 | 7 |
| Not Hispanic or Latino | 23 | 24 | 8 | 55 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | tDCS | Sham tDCS | Not Randomized | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 2 | 6 |
| White | 23 | 22 | 5 | 50 |
| More than one race | 2 | 1 | 1 | 4 |
| Unknown or Not Reported | 1 | 1 | 0 | 2 |
| Region of Enrollment(participants) | tDCS | Sham tDCS | Not Randomized | Total |
|---|---|---|---|---|
| United States | 27 | 27 | 8 | 62 |
| Opioid Craving(units on a scale) | tDCS | Sham tDCS | Not Randomized | Total |
|---|---|---|---|---|
| Mean | 11.07 ± 8.39 | 8.85 ± 7.84 | 8.75 ± 8.88 | 9.81 ± 8.12 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Jun 2019 to primary completion in Apr 2023, 46 months.
Results were first posted in Sep 2024, 1 year 4 months after primary completion.
Of 460 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 46 months is above that.
Counting every sponsor, half of 491 studies reached it within 28 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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