Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
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ClinicalTrials.gov Identifier: NCT05976646 |
Recruitment Status :
Recruiting
First Posted : August 4, 2023
Last Update Posted : November 22, 2023
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Condition or disease | Intervention/treatment | Phase |
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Addiction Opioid Use Substance Use Disorders Opioid Use Disorder | Drug: Placebo Drug: Auvelity | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | September 18, 2023 |
Estimated Primary Completion Date : | January 2025 |
Estimated Study Completion Date : | January 2025 |
Arm | Intervention/treatment |
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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.
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Drug: Placebo
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)
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Drug: 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. |
- 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)
- 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
- 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
- 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
- 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
- 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
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05976646
Contact: Tiffany Pignatello | 804-828-3686 | Tfitz@vcu.edu | |
Contact: Kameron Simmons | 804-827-3784 | simmonsk5@vcu.edu |
United States, Virginia | |
CARI Research Clinic- VCU Institute for Drug and Alcohol Studies | Recruiting |
Richmond, Virginia, United States, 23219 | |
Contact: Tiffany Pignatello, NP 804-828-3686 |
Principal Investigator: | Frederick G Moeller | Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT05976646 |
Other Study ID Numbers: |
HM20027635 5UG1DA050207 ( U.S. NIH Grant/Contract ) |
First Posted: | August 4, 2023 Key Record Dates |
Last Update Posted: | November 22, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Substance-Related Disorders Opioid-Related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders |