Trial · NCT05976646
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
NCT05976646, Phase 1, Phase 2, Completed, Virginia Commonwealth University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion. Trials, record NCT05976646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05976646
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
- NCT number
- NCT05976646
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Addiction, Opioid Use, Substance Use Disorders, Opioid Use Disorder
- Interventions
- Placebo, Auvelity
- First posted
- 2023-08-04
- Last updated
- 2026-08-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety- as Measured by Average Heart Rate (Pulse) at Each Testing Visit | Baseline and Day 8 (PK testing visits) | Measuring pulse is crucial for providing real-time, objective data. It acts as a baseline indicator to detect irregularities and monitor for stress and fatigue levels. The healthy resting heart rate (RHR) for most adults is 60-100 beats per minute (bpm). A lower rate usually indicates better cardiovascular fitness. A poor score is falling above the 60-100bpm range. |
| Primary | Safety- as Measured by Average Blood Pressure at Each Testing Visit | Baseline and Day 8 (PK testing visits) | Systolic blood pressure is the first (top/upper) number. It measures the pressure your blood is pushing against your artery walls when the heart beats. Diastolic blood pressure is the second (bottom/lower) number. It measures the pressure your blood is pushing against your artery walls while the heart muscle rests between beats. A good, healthy blood pressure for most adults is generally considered to be less than 120/80 mm Hg. It ensures participant safety by monitoring for extreme hypertension or hypotension, validating cardiovascular drug effects. Anything abovethe 130/80 mmHg is considered a high or bad reading. A high reading means that your heart is working too hard to pump blood and putting excessive strain on the arteries. |
| Primary | Safety- as Measured by Average Pulse Oximetry at Each Testing Visit | Baseline and Day 8 (PK testing visits) | Measuring pulse oximetry (SpO2) for research safety provides real-time, noninvasive monitoring of oxygen saturation, crucial for identifying "silent hypoxia," detecting respiratory decline from interventions, and ensuring participant safety during trials. The normal range is 95%-100%. Anything below the 95% is out of normal range and cause for concern. |
| Primary | Safety- as Measured by Average Respiratory Rate at Each Testing Visit | Baseline and Day 8 (PK testing visits) | A good, normal respiratory rate for research safety data in resting adults is 12 to 20 breaths per minute (bpm). Rates consistently under 12 or over 25 bpm are often flagged in clinical studies as potential safety concerns. |
| Primary | Safety- as Measured by Total Number of Adverse Events | Baseline to Week 2 follow-up | Tracking adverse event (AE) rates in research is essential to ensure participant safety, determine the risk-benefit ratio of interventions, and maintain data integrity for regulatory approval. Analyzing these rates allows investigators to identify trends, detect unexpected risks early, and modify studies to prevent harm. . |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| UG1DA050207 | Laboratories for Early Clinical Evaluation of Pharmacotherapies for Substance Use Disorders | MOELLER, FREDERICK GERARD; ARIAS, ALBERT JOSEPH | VIRGINIA COMMONWEALTH UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2020 to 2024 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05976646
GET https://conductscience.org/api/trials/v1/NCT05976646/registered