CLINICAL TRIALS PROFILE FOR BUPROPION HYDROCHLORIDE
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505(b)(2) Clinical Trials for bupropion hydrochloride
| 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. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for bupropion hydrochloride
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Clinical Trial Sponsors for bupropion hydrochloride
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