bupropion sustained-release / Generic mfg. - LARVOL DELTA

Tobacco Use Treatment: Synopsis of the 2026 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline. (PubMed, Ann Intern Med) - "Key recommendations for increasing abstinence from combustible tobacco include recommending motivational interviewing to increase engagement in treatment of tobacco and nicotine use (strong) and use of U.S. Food and Drug Administration-approved pharmacotherapies (strong), with varenicline recommended over monotherapy with other agents (strong), combination nicotine replacement therapy ([NRT] for example, patch plus lozenge) recommended over NRT monotherapy (single agent) (strong), and extending use of bupropion sustained release beyond 12 weeks (weak). Other key recommendations include varenicline for increasing abstinence from smokeless tobacco (strong) and electronic nicotine delivery systems (weak) and use of NRT or varenicline to increase quit attempts and abstinence in patients not ready to quit in the next 30 days (weak)."

Clinical guideline • Journal

What are the clinical implications of mixed features in major depressive disorder? A VAST-D report. (PubMed, J Psychopharmacol) - "Mixed features were highly prevalent and associated with greater clinical burden. Assessment of mixed features may provide clinically relevant information when selecting next-step pharmacologic strategies, particularly when considering a switch to bupropion sustained release."

Journal • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry • Suicidal Ideation

PhenoRXPrag: Pragmatic Trial to Study the Cost-Effectiveness of MyPhenome-RX Test to Guide Anti-Obesity Pharmacotherapy (clinicaltrials.gov) - P=N/A | N=424 | Not yet recruiting | Sponsor: Phenomix Sciences

HEOR • New trial • Genetic Disorders • Obesity

Integration of tobacco cessation into routine HIV care in Kenya: results from the InTOUCH cluster-randomized trial (AIDS 2026) - P4 | "Clinics were randomized (1:1) to deliver either (i) guideline-aligned single-session behavioral counseling based on the 5As (Ask, Advise, Assess, Assist, and Arrange) plus referral to a quit line (brief intervention), or (ii) 12 weeks of 5As-based counselling (3 in-person and 9 phone/text-based sessions) and pharmacotherapy (bupropion SR plus dose-tailored nicotine replacement as needed) (intensive intervention)... An intensive intervention including multi-session behavioral cessation counseling and pharmacotherapy was feasible to implement in primary HIV care clinics in Kenya and increased biochemically verified tobacco cessation relative to brief 5As-based counselling and quit line referral. These findings support integration of tobacco cessation services into routine HIV care to reduce tobacco-attributable morbidity and mortality in low- and middle-income countries."

Clinical • Human Immunodeficiency Virus • Infectious Disease • Tobacco Cessation

Cost-effectiveness of integration of tobacco cessation services into HIV care: results from a cluster-randomised trial in Kisumu, Kenya (AIDS 2026) - P4 | "Clinics were randomised to provide either: (1) guideline-alligned single-session counselling based on the 5As (Ask, Advise, Assess, Assist, and Arrange) plus referral to a quitline (brief intervention); or (2) 12 weeks of 5As-based counselling (3 in-person and 9 phone/text-based sessions) and pharmacotherapy (bupropion SR plus dose-tailored nicotine replacement as needed) (intensive intervention)... Integrating behavioural counselling and pharmacotherapy for tobacco cessation into primary HIV care in Kenya was cost-effective and may be cost-saving. These findings support scale-up of intensive cessation services as part of comprehensive HIV care in similar settings."

Clinical • Cost effectiveness • HEOR • Human Immunodeficiency Virus • Infectious Disease • Tobacco Cessation

Adverse events during tobacco dependence treatment and cessation outcomes among people living with HIV in Western Kenya (AIDS 2026) - "Clinics were randomized to provide either brief 5As-based counseling at enrollment with quitline referral or an intensive intervention comprising weekly 5As-based counseling over 12 weeks combined with pharmacotherapy (sustained-release bupropion and nicotine replacement therapy)... Adverse events during TDT were infrequent and did not negatively impact retention, cessation outcomes, or HIV viral suppression. Awareness of commonly reported AEs may support informed clinical decision-making and optimize treatment expectations among PWH."

Adverse events • Anorexia • Human Immunodeficiency Virus • Infectious Disease • Insomnia • Nicotine Addiction • Sleep Disorder • Tobacco Addiction • Xerostomia

New HART: Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness (clinicaltrials.gov) - P=N/A | N=120 | Not yet recruiting | Sponsor: VA Office of Research and Development

New trial • Nicotine Addiction • Tobacco Addiction

A Trial of Dextromethorphan and Bupropion Sustained-Release Tablets in Patients With Major Depressive Disorder (clinicaltrials.gov) - P3 | N=388 | Completed | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Simultaneous quantification of bupropion and hydroxybupropion in human plasma by UA-DLLME-LC-MS/MS with central composite design optimization and CYP2B6 phenotyping application. (PubMed, Talanta) - "Chromatographic separation of both analytes and the internal standard carbamazepine was achieved on an Agilent Poroshell 120 EC-C18 column (50 × 4.6 mm, 2.7 μm) using an isocratic mobile phase of 10 mM ammonium formate (pH 4.0) and acetonitrile (35:65, v/v) at 0.4 mL/min, with a total runtime of 5 min. The method was successfully applied to a single-dose pharmacokinetic study in five healthy volunteers following bupropion SR 150 mg administration. The assay measures total (non-stereoselective) hydroxybupropion, and the hydroxybupropion/bupropion AUC metabolic ratios of 6.55-11.68 serve as surrogate indices of CYP2B6 hydroxylation activity, classifying all subjects as CYP2B6 extensive metabolizers and demonstrating the method's utility for CYP2B6 phenotyping and precision pharmacotherapy applications."

Journal

BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: University of Illinois at Chicago

New P1/2 trial • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Sexual Disorders • Solid Tumor • ER • PGR

Recurrent Seizure Induced an Overdose of Bupropion Hydrochloride Sustained-Release Tablets in an Adolescent: A Management Analysis. (PubMed, J Coll Physicians Surg Pak) - "Null."

Journal • CNS Disorders • Epilepsy

Randomized Controlled Trial of a Group-Based Smoking Cessation Intervention for Adults With Serious Mental Illness. (PubMed, Nicotine Tob Res) - P4 | "Although there were no significant differences between study groups, both study groups showed a significant reduction in cigarettes smoked each week and in psychiatric symptoms. Group-based counseling and pharmacotherapy likely contributed to these improvements. Future research should assess longer-term outcomes in sustaining smoking cessation. Clinical Trials Registration Number: NCT03950427."

Journal • CNS Disorders • Psychiatry • Tobacco Cessation

BUPRO-08-24: A double blinded, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study comparing Bupropion Hydrochloride Sustained-Release Tablets 150 mg, manufactured for Sun Pharmaceutical Industries Limited, India with PrOdan Bupropion SR (Bupropion Hydrochloride Sustained-Release Tablets 150 mg), product of Odan Laboratories Ltd., 325... (clinicaltrialsregister.eu) - P1 | N=56 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited

New P1 trial • CNS Disorders • Depression • Major Depressive Disorder

BUPRO-07-24: A double blinded, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study comparing Bupropion Hydrochloride Sustained-Release Tablets 150 mg, manufactured for Sun Pharmaceutical Industries Limited, India with PrOdan Bupropion SR (Bupropion Hydrochloride Sustained-Release Tablets 150 mg), product of Odan Laboratories Ltd., 325... (clinicaltrialsregister.eu) - P1 | N=56 | Active, not recruiting | Sponsor: Sun Pharmaceutical Industries Limited

New P1 trial • CNS Disorders • Depression • Major Depressive Disorder

BUPRO-07-24: A double blinded, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study comparing Bupropion Hydrochloride Sustained-Release Tablets 150 mg, manufactured for Sun Pharmaceutical Industries Limited, India with PrOdan Bupropion SR (Bupropion Hydrochloride Sustained-Release Tablets 150 mg), product of Odan Laboratories Ltd., 325... (clinicaltrialsregister.eu) - P1 | N=56 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder

BUPRO-08-24: A double blinded, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study comparing Bupropion Hydrochloride Sustained-Release Tablets 150 mg, manufactured for Sun Pharmaceutical Industries Limited, India with PrOdan Bupropion SR (Bupropion Hydrochloride Sustained-Release Tablets 150 mg), product of Odan Laboratories Ltd., 325... (clinicaltrialsregister.eu) - P1 | N=56 | Completed | Sponsor: Sun Pharmaceutical Industries Limited | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder

(KISV): Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: University of Kansas Medical Center | Trial primary completion date: Oct 2026 ➔ Jan 2027

Trial primary completion date • Tobacco Cessation

The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette (clinicaltrials.gov) - P3 | N=180 | Completed | Sponsor: Rose Research Center, LLC | Active, not recruiting ➔ Completed

Trial completion • Tobacco Cessation

Comparative Risk of New-Onset Seizure Among Smoking Cessation Pharmacotherapies (AES 2025) - "A p-value of < 0.05 was considered significant. Nicotine replacement therapy (NRT) (1,417; 27%), varenicline (3,153; 62%), bupropion sustained-release (244; 5%), or combination therapy (328; 6%) were used. This study demonstrates that overall incidence of new-onset seizures is high in tobacco smokers started on SCT. When comparing treatment groups, increased risk of new-onset seizure was identified only with NRT relative to varenicline. Although smoking cessation has significant health benefits, patients on SCT require close monitoring for seizure occurrence."

CNS Disorders • Epilepsy • Tobacco Cessation

Restoring STAR*D: A RIAT Reanalysis of Medication Augmentation Therapy After Failed SSRI Treatment Using Patient-Level Data with Fidelity to the Original Research Protocol. (PubMed, medRxiv) - "A similar reanalysis is warranted for STAR*D's augmentation study in which citalopram was augmented with sustained-release bupropion or buspirone. Compared with the original STAR*D publication, our reanalysis identified inflated remission rates, low sustained remission, and marked differences in TESI risk between augmentation strategies. These findings suggest that both treatments offer lower acute and sustained benefit than is widely understood, with buspirone associated with more TESI."

Journal • Psychiatry • Suicidal Ideation

CPT-SMART for Treatment of PTSD and Cigarette Smoking (clinicaltrials.gov) - P4 | N=120 | Completed | Sponsor: VA Office of Research and Development | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

CPT-SMART for Treatment of PTSD and Cigarette Smoking (clinicaltrials.gov) - P4 | N=120 | Active, not recruiting | Sponsor: VA Office of Research and Development | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder

PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness (clinicaltrials.gov) - P4 | N=131 | Completed | Sponsor: University of California, San Francisco | Recruiting ➔ Completed

Trial completion • CNS Disorders • Nicotine Addiction • Tobacco Addiction • Tobacco Cessation

Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening (clinicaltrials.gov) - P=N/A | N=3228 | Completed | Sponsor: Abramson Cancer Center at Penn Medicine | Active, not recruiting ➔ Completed

Trial completion • Lung Cancer • Oncology • Solid Tumor • Tobacco Cessation

Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya (clinicaltrials.gov) - P4 | N=580 | Completed | Sponsor: University of California, San Francisco | Active, not recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Jan 2025

Trial completion • Trial completion date • Human Immunodeficiency Virus • Infectious Disease • Tobacco Cessation