- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05976646
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
November 20, 2023 updated by: Virginia Commonwealth University
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion (AUVELITY) as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder
The overall goal of this project is to collect initial human data on the effects of novel compounds on safety (interactions with an opioid drug, e.g., buprenorphine) and early efficacy signals (subjective effects on negative affect, craving, and opioid withdrawal) in OUD subjects currently in MOUD treatment with buprenorphine.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
The overall goal of this project is to collect initial human data on the effects of novel compounds on safety (interactions with an opioid drug, e.g., buprenorphine) and early efficacy signals (subjective effects on negative affect, craving, and opioid withdrawal) in OUD subjects currently in MOUD treatment with buprenorphine.
The compound to be studied in this protocol will be a pre-configured combination of 45mg dextromethorphan with 105 mg Bupropion (AuvelityTM, hereafter referred as Auvelity).
Notably, other NMDA receptor antagonists such as ketamine have also been shown to rapidly improve mood and reduce suicidality.
OUD has also been linked to histories of trauma and syndromes of negative mood, where opioid use in many individuals was initially motivated by a desire to alleviate a negative mood state.
Lastly, using the NIDA Phenotyping Battery, our group has also found negative emotionality to be part of a constellation of neurofunctional domains that are associated with SUD severity.
Taken together, providing AUVELITY as an adjunctive treatment to buprenorphine could be an avenue to target crucial underlying mechanisms of OUD and improve OUD treatment outcomes.
Study Type
Interventional
Enrollment (Estimated)
18
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tiffany Pignatello
- Phone Number: 804-828-3686
- Email: Tfitz@vcu.edu
Study Contact Backup
- Name: Kameron Simmons
- Phone Number: 804-827-3784
- Email: simmonsk5@vcu.edu
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23219
- Recruiting
- CARI Research Clinic- VCU Institute for Drug and Alcohol Studies
-
Contact:
- Tiffany Pignatello, NP
- Phone Number: 804-828-3686
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Males and female subjects between 18 - 65 years of age;
- Understand the study procedures and provide written informed consent in the English language.
- Meet current DSM-5 criteria for OUD, of at least moderate severity, currently engaged in MOUD treatment at a buprenorphine-naloxone sublingual film total daily dose ranging from 8mg/2mg to 24mg/6mg or buprenorphine sublingual tablet 5.7mg/1.4mg to 17.1/4.3 daily for at least 2 weeks at screening. Or on a stable dose of depot injectable buprenorphine for at least four months, with at least one week since last depot buprenorphine injection.
- Have a positive urine drug screen for buprenorphine during screening and upon presenting for the first laboratory day on the clinical research unit to document buprenorphine use;
- Quick Inventory of Depressive Symptomatology (16-Item) (QIDS-SR16) score of mild or greater (>6)
- Females must be non-pregnant and non-lactating. Additionally, for females with childbearing potential (ie., have not undergone sterilization via hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, or at least 1 year post-menopausal), participants must agree to use an acceptable form of contraception during study participation and to continue its use for at least 30 days after the last dose of the study drug (e.g, abstinence, intrauterine device, hormonal implant, hormonal patch/ring/pill, condoms (male or female).
Exclusion Criteria:
- Contraindications for participation as determined by medical history and physical exam performed by study NP or study physician;
- Pregnant or nursing women;
- Baseline ECG with clinically significant abnormal conduction;
- Uncontrolled serious psychiatric or major medical disorder; including uncontrolled hypertension, seizure disorder, anorexia nervosa or bulimia, bipolar disorder, schizoaffective disorder, or schizophrenia;
- Taking antidepressant medications (tricyclic antidepressants, SSRIs, SNRIs, MAOIs), antibiotic linezolid, antiepileptics, or CNS stimulants (amphetamine, methylphenidate) within the two weeks prior to initiation of study medication
- History of adverse reaction or allergy to dextromethorphan or bupropion
- Current severe alcohol use disorder or current benzodiazepine use or recent (within last 3 months) discontinuation of alcohol with severe alcohol use disorder or discontinuation of benzodiazepines with severe benzodiazepine use disorder
- Current DSM-5 diagnosis of any psychoactive substance use disorder other than opioids, cocaine, marijuana, or nicotine, or mild or moderate alcohol use disorder. Diagnosis of mild to moderate use disorder for alcohol will not be considered exclusionary.
- Significant current suicidal or homicidal ideation (C-SSRS "yes" answers on questions 4 or 5) or a history of suicide attempt within the past 6 months.
- Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
|
Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
|
Experimental: Auvelity
Orally-administered combination of dextromethorphan with Bupropion (trade name Auvelity)
|
Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity).
Auvelity will initially be administered orally once daily for three days.
After 3 days on once daily AUVELITY, the participants will begin taking AUVELITY twice daily for 4 additional days as recommended in the FDA-approved prescribing information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety- as measured by heart rate
Time Frame: During each PK study visit from visit start to end, up to approximately 8 hours
|
Heart rate (HR)
|
During each PK study visit from visit start to end, up to approximately 8 hours
|
Safety- as measured by blood pressure
Time Frame: During each PK study visit from visit start to end, up to approximately 8 hours
|
blood pressure
|
During each PK study visit from visit start to end, up to approximately 8 hours
|
Safety- as measured by pulse oximetry
Time Frame: During each PK study visit from visit start to end, up to approximately 8 hours
|
pulse oximetry
|
During each PK study visit from visit start to end, up to approximately 8 hours
|
Safety- as measured by respiratory rate
Time Frame: During each PK study visit from visit start to end, up to approximately 8 hours
|
respiratory rate
|
During each PK study visit from visit start to end, up to approximately 8 hours
|
Safety- as measured by Adverse events
Time Frame: During each PK study visit from visit start to end, up to approximately 8 hours; and from baseline to end of study participation
|
adverse events
|
During each PK study visit from visit start to end, up to approximately 8 hours; and from baseline to end of study participation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Buprenorphine PK
Time Frame: During each PK study visit from visit start to end, up to approximately 8 hours
|
Plasma concentration-time profiles of buprenorphine and its metabolite norbuprenorphine
|
During each PK study visit from visit start to end, up to approximately 8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Frederick G Moeller, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 18, 2023
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
July 24, 2023
First Submitted That Met QC Criteria
August 3, 2023
First Posted (Actual)
August 4, 2023
Study Record Updates
Last Update Posted (Actual)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20027635
- 5UG1DA050207 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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