Effects of Pharmacological Stress and rTMS on Executive Function in Opioid Use Disorder
NCT04231708, Phase 2, Not yet recruiting, Wayne State University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Pharmacological Stress and rTMS on Executive Function in Opioid Use Disorder | ClinicalTrials.gov |
| NCT number | NCT04231708 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Wayne State University | ClinicalTrials.gov |
| Conditions | Opioid Use Disorder | ClinicalTrials.gov |
| Interventions | Yohimbine + Hydrocortisone, Active rTMS, Placebo, Sham rTMS | ClinicalTrials.gov |
| First posted | 2020-01-18 | ClinicalTrials.gov |
| Last updated | 2025-12-30 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Color-Word Stroop Task | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | measures cognitive control in response to opioid-related words. | ClinicalTrials.gov |
| Primary | Digit Span Task | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | measures verbal working memory. Participants are asked to repeat strings of numbers of increasing length, both forward and backward. | ClinicalTrials.gov |
| Primary | Wisconsin Card Sorting Task | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | measures ability to shift set and assesses cognitive flexibility. | ClinicalTrials.gov |
| Primary | Emotion Regulation Task | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | subjects rate the unpleasantness and arousal of different emotional pictures | ClinicalTrials.gov |
| Primary | Positive and Negative Affect Schedule | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | subjects rate their positive and negative affect | ClinicalTrials.gov |
| Primary | State-Trait Anxiety Inventory | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | subjects rate their level state anxiety | ClinicalTrials.gov |
| Primary | Monetary Incentive Delay Task | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | Participants respond to a visual target that follows 2 different cues: incentive or non-incentive. No reward or punishment occurs on non-incentive trials. On incentive trials, participants must respond within a fixed amount of time. In the reward condition, responses within that time result in receiving the incentive , else nothing. In the punishment condition, the participant will lose money if they do not respond within the time limit | ClinicalTrials.gov |
| Primary | Delay Discounting Task | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | Participants perform a brief (\<1min) hypothetical version of the traditional monetary task with a 5-trial adjusting delay previously validated to rapidly assess discount rate | ClinicalTrials.gov |
| Primary | Drug/Money Choice Task | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | participants choose hypothetically between a constant amount of their preferred opioid ($10 unit dose) or money ($2) | ClinicalTrials.gov |
| Primary | Systolic blood pressure | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | millimeters mercury (mmHg) | ClinicalTrials.gov |
| Primary | Diastolic blood pressure | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | millimeters mercury (mmHg) | ClinicalTrials.gov |
| Primary | Heart rate | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | beats per minute | ClinicalTrials.gov |
| Primary | Saliva cortisol level | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | measure of the activity of the HPA axis | ClinicalTrials.gov |
| Primary | Saliva alpha-amylase level | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | indirect measure of adrenergic stimulation | ClinicalTrials.gov |
| Primary | Serum prolactin level | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | indirect measure of dopamine stimulation | ClinicalTrials.gov |
| Primary | Serum brain derived neurotrophic factor (BDNF) level | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | indirect measure of brain derived neurotrophic factor activation | ClinicalTrials.gov |
| Primary | Relative electroencephalogram (EEG) gamma power | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | Prefrontal gamma (25-100 Hz) EEG power, relative to slow-wave EEG power, is a stress biomarker | ClinicalTrials.gov |
| Secondary | Opioid craving | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | Desire for Drug Questionnaire total score; higher scores indicate greater craving | ClinicalTrials.gov |
| Secondary | Opioid agonist symptoms | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | Opiate-32 questionnaire agonist symptom total score; higher scores indicate greater opioid symptom severity | ClinicalTrials.gov |
| Secondary | Opioid withdrawal symptoms | change from pre- to post-intervention in each of 4 sessions (through study completion, about 1 month total) | Opiate-32 questionnaire withdrawal symptom total score; higher scores indicate greater withdrawal severity | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Primary outcome | ConductCognition |
| Delay Discounting | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Emotion Regulation Task | Primary outcome | ConductCognition |
| Monetary Incentive Delay | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)