An interventional study of Transcranial Direct Current Stimulation (tDCS) and Sham Transcranial Direct Current Stimulation (tDCS) in Opioid-Related Disorders, Heroin Dependence and Morphine Dependence, sponsored by University of Minnesota. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcrancial direct current stimulation (tDCS) for new addiction treatments that support long-term abstinence. This study will investigate whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive training can enhance functional connectivity between DLPFC and nucleus accumbens (NAcc). We have identified higher functional connectivity between DLPFC and NAcc in alcoholics that have successfully maintained abstinence for extended periods of time (7 years). This paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease substance use probability in addiction (e.g. opioid use disorder). The long term goal is to develop new addiction treatments that support long-term abstinence in opioid use disorder. The overall objective of this proposal is to enhance functional connectivity between DLPFC and NAcc as a therapeutic intervention to enhance cognition and reduce substance use rates in opioid use disorder.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 9 is below the median of 87 across 57 interventional studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
Compared within Heroin Dependence, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Opioid-Related Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DLPFC stimulation with tDCS with simultaneous cognitive training
Device: Transcranial Direct Current Stimulation (tDCS) · Behavioral: Cognitive Training
Sham tDCS with simultaneous cognitive training
Device: Sham Transcranial Direct Current Stimulation (tDCS) · Behavioral: Cognitive Training
Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex)
Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS)
Executive functioning tasks
(A1) Average Number of Serious Adverse Events in Active and Sham Groups.
Safety was defined as the prevalence of Serious Adverse Events for the study. Subjects were monitored for Serious Adverse Events from date of first intervention session until the final follow-up visit (2 months post-intevention). Subjects were monitored using the Symptom Rating Questionnaire (SRQ), Medication/Medical Update Interview, and medical chart review. Serious Adverse Events were defined as: Death, life threatening incidents, hospitalizations (initial or prolonged), disability or permanent damage, congenital anomaly or birth defect, or an event that required intervention to prevent permanent impairment or damage. Mean and standard deviation of Serious Adverse Events was recorded across groups. A lower number indicates fewer Serious Adverse Events.
Time frame: 2months post-intervention
(A2) Activation Levels in Brain Circuits in Active and Sham Groups.
Brain activation change from pre-intervention to post-intervention was planned to be compard between active tDCS and sham groups. We hypothesized that the active tDCS group will have a larger increase in brain circuit engagement than the sham group and, thus, a better outcome.
Time frame: 1-week post-intervention
(A3) Changes in Scaled Score on Digit Span Task.
Cognitive performance change was compared between active tDCS and sham groups. Cognitive performance change was defined as improvement on the WAIS-IV Digit Span (DS). Score was calculating by subtracting the DS scaled score at baseline from the DS scaled score at 2-Month Follow Up. We hypothesized that the active tDCS group will have a larger improvement in cognitive performance than the sham group. A higher number indicates a higher impact of cognitive training and, thus, a better outcome. The DS Scaled Score has a range between 1 (min.) and 10 (max). Therefore, the computed difference between two DS Scaled Scores has a range of -9 (min.) to 9 (max.)
Time frame: 2 months post-intervention
(A4) Number of Participants Who Relapsed After Intervention.
Relapse was defined as any illiciit drug use (whether reported by the patient or reported as a positive drug screen in study or medical records) that occurred at some point between study intervention and the final follow-up visit (2 months post-intervention). Relapse was measured with the Timeline Follow Back questionnaire, saliva drug screen at the study visit, and chart review of urine drug screens. Relapse was coded 0 (did not relapse during the study) or 1 (relapsed during the study). We hypothesized that the active tDCS group will have a lower relapse rate than the sham group. A higher number indicates a higher count of participants with a relapse.
Time frame: 2 months post-intervention
Changes in Scaled Score on Digit Symbol Task.
"Durability of cognitive training was defined as improvement on the WAIS-IV Digit Scale Symbol/Coding (CD) test. The improvement period was measured between baseline and the study completion (2 months post-intervention). The score was calculated by subtracting the CD scaled score at baseline from the CD Scaled Score at 2-months post-intervention. A higher number indicates a higher impact on cognitive abilities, and a better outcome. The CD Scaled Score has a range between 1 (min.) and 10 (max). Therefore, the computed difference between two CD Scaled Scores has a range of -9 (min.) to 9 (max.)"
Time frame: 2-months post-intervention
| Milestone | tDCS With Cognitive Training | Sham tDCS With Cognitive Training |
|---|---|---|
| Started | 5 | 4 |
| Completed | 3 | 2 |
| Not completed | 2 | 2 |
Safety was defined as the prevalence of Serious Adverse Events for the study. Subjects were monitored for Serious Adverse Events from date of first intervention session until the final follow-up visit (2 months post-intevention). Subjects were monitored using the Symptom Rating Questionnaire (SRQ), Medication/Medical Update Interview, and medical chart review. Serious Adverse Events were defined as: Death, life threatening incidents, hospitalizations (initial or prolonged), disability or permanent damage, congenital anomaly or birth defect, or an event that required intervention to prevent permanent impairment or damage. Mean and standard deviation of Serious Adverse Events was recorded across groups. A lower number indicates fewer Serious Adverse Events.
| Number of adverse events | tDCS With Cognitive Training | Sham tDCS With Cognitive Training |
|---|---|---|
| (A1) Average Number of Serious Adverse Events in Active and Sham Groups. | 0 ± 0 | 0 ± 0 |
Brain activation change from pre-intervention to post-intervention was planned to be compard between active tDCS and sham groups. We hypothesized that the active tDCS group will have a larger increase in brain circuit engagement than the sham group and, thus, a better outcome.
No measurements were reported for this outcome.
Cognitive performance change was compared between active tDCS and sham groups. Cognitive performance change was defined as improvement on the WAIS-IV Digit Span (DS). Score was calculating by subtracting the DS scaled score at baseline from the DS scaled score at 2-Month Follow Up. We hypothesized that the active tDCS group will have a larger improvement in cognitive performance than the sham group. A higher number indicates a higher impact of cognitive training and, thus, a better outcome. The DS Scaled Score has a range between 1 (min.) and 10 (max). Therefore, the computed difference between two DS Scaled Scores has a range of -9 (min.) to 9 (max.)
| score on a scale | tDCS With Cognitive Training | Sham tDCS With Cognitive Training |
|---|---|---|
| (A3) Changes in Scaled Score on Digit Span Task. | -2.7 ± 1.7 | -1.5 ± 1.5 |
Relapse was defined as any illiciit drug use (whether reported by the patient or reported as a positive drug screen in study or medical records) that occurred at some point between study intervention and the final follow-up visit (2 months post-intervention). Relapse was measured with the Timeline Follow Back questionnaire, saliva drug screen at the study visit, and chart review of urine drug screens. Relapse was coded 0 (did not relapse during the study) or 1 (relapsed during the study). We hypothesized that the active tDCS group will have a lower relapse rate than the sham group. A higher number indicates a higher count of participants with a relapse.
| Participants | tDCS With Cognitive Training | Sham tDCS With Cognitive Training |
|---|---|---|
| (A4) Number of Participants Who Relapsed After Intervention. | 2 | 0 |
"Durability of cognitive training was defined as improvement on the WAIS-IV Digit Scale Symbol/Coding (CD) test. The improvement period was measured between baseline and the study completion (2 months post-intervention). The score was calculated by subtracting the CD scaled score at baseline from the CD Scaled Score at 2-months post-intervention. A higher number indicates a higher impact on cognitive abilities, and a better outcome. The CD Scaled Score has a range between 1 (min.) and 10 (max). Therefore, the computed difference between two CD Scaled Scores has a range of -9 (min.) to 9 (max.)"
| score on a scale | tDCS With Cognitive Training | Sham tDCS With Cognitive Training |
|---|---|---|
| Changes in Scaled Score on Digit Symbol Task. | -1 ± 3.6 | -1 ± 6 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| tDCS With Cognitive Training | 0/5 (0%) | 0/5 (0%) | 4/5 (80%) |
| Sham tDCS With Cognitive Training | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Event | tDCS With Cognitive Training | Sham tDCS With Cognitive Training |
|---|---|---|
| poor concentrationGeneral disorders | 4/5 | 1/4 |
| itching sensationGeneral disorders | 3/5 | 1/4 |
| sleepiness/fatigueGeneral disorders | 3/5 | 1/4 |
| tingling sensationGeneral disorders | 2/5 | 1/4 |
| burning sensationGeneral disorders | 2/5 | 0/4 |
| skin rednessGeneral disorders | 2/5 | 0/4 |
| acute mood changeGeneral disorders | 2/5 | 1/4 |
| HeadacheGeneral disorders | 1/5 | 0/4 |
| neck painMusculoskeletal and connective tissue disorders | 1/5 | 0/4 |
| NauseaGeneral disorders | 1/5 | 0/4 |
| Age, Categorical(Participants) | tDCS With Cognitive Training | Sham tDCS With Cognitive Training | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 4 | 9 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | tDCS With Cognitive Training | Sham tDCS With Cognitive Training | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | tDCS With Cognitive Training | Sham tDCS With Cognitive Training | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 1 | 4 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2021 to primary completion in Feb 2022, 13 months.
Results were first posted in Jul 2025, 3 years 4 months after primary completion.
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This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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