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Last Updated: May 28, 2022

CLINICAL TRIALS PROFILE FOR BUPROPION HYDROCHLORIDE


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505(b)(2) Clinical Trials for Bupropion Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00405912 ↗ St. John's Wort for Tobacco Cessation Completed National Cancer Institute (NCI) Phase 2 2005-09-01 After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism.
OTC NCT00405912 ↗ St. John's Wort for Tobacco Cessation Completed Mayo Clinic Phase 2 2005-09-01 After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting Los Angeles Clinical Trials Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting National Institute on Drug Abuse (NIDA) Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting Pfizer Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting University of Nevada, Reno Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 ↗ Varenicline OTC Trial on Efficacy and Safety Recruiting Arizona State University Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Bupropion Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000268 ↗ Cocaine Abuse and Attention Deficit Disorder - 3 Completed New York State Psychiatric Institute N/A 1995-05-01 The purpose of this study is to evaluate cocaine abuse and Attention Deficit Disorder
NCT00000268 ↗ Cocaine Abuse and Attention Deficit Disorder - 3 Completed National Institute on Drug Abuse (NIDA) N/A 1995-05-01 The purpose of this study is to evaluate cocaine abuse and Attention Deficit Disorder
NCT00000276 ↗ Dopamine Reuptake Inhibitors of Cocaine Abuse - 1 Terminated National Institute on Drug Abuse (NIDA) Phase 1 1994-09-01 The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.
NCT00000276 ↗ Dopamine Reuptake Inhibitors of Cocaine Abuse - 1 Terminated VA Connecticut Healthcare System Phase 1 1994-09-01 The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.
NCT00000276 ↗ Dopamine Reuptake Inhibitors of Cocaine Abuse - 1 Terminated Yale University Phase 1 1994-09-01 The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.
NCT00000457 ↗ Pharmacologic Relapse Prevention for Alcoholic Smokers Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 1998-06-01 This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.
NCT00000457 ↗ Pharmacologic Relapse Prevention for Alcoholic Smokers Completed Mayo Clinic Phase 2 1998-06-01 This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bupropion Hydrochloride

Condition Name

Condition Name for Bupropion Hydrochloride
Intervention Trials
Smoking Cessation 42
Nicotine Dependence 35
Tobacco Use Disorder 30
Major Depressive Disorder 28
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Condition MeSH

Condition MeSH for Bupropion Hydrochloride
Intervention Trials
Depression 83
Depressive Disorder 75
Tobacco Use Disorder 74
Depressive Disorder, Major 56
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Clinical Trial Locations for Bupropion Hydrochloride

Trials by Country

Trials by Country for Bupropion Hydrochloride
Location Trials
United States 924
Canada 48
China 19
Germany 11
Australia 10
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Trials by US State

Trials by US State for Bupropion Hydrochloride
Location Trials
California 55
New York 55
North Carolina 50
Texas 48
Massachusetts 36
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Clinical Trial Progress for Bupropion Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Bupropion Hydrochloride
Clinical Trial Phase Trials
Phase 4 102
Phase 3 49
Phase 2/Phase 3 24
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Clinical Trial Status

Clinical Trial Status for Bupropion Hydrochloride
Clinical Trial Phase Trials
Completed 261
Recruiting 31
Terminated 23
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Clinical Trial Sponsors for Bupropion Hydrochloride

Sponsor Name

Sponsor Name for Bupropion Hydrochloride
Sponsor Trials
National Institute on Drug Abuse (NIDA) 67
GlaxoSmithKline 29
Yale University 24
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Sponsor Type

Sponsor Type for Bupropion Hydrochloride
Sponsor Trials
Other 386
NIH 136
Industry 124
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