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The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.
This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3 weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week follow-up period, with scheduled visits during Study weeks 14 and 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin | Active Comparator | 10 mg capsule by mouth, twice a day, for 13 weeks |
|
| Placebo Oral Capsule | Placebo Comparator | 10 mg placebo capsule, twice a day, for 13 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin | Drug | Lorcaserin Capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the "Pre-qualified for Primary Efficacy Endpoint" (PPEE) Population | Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period. | Treatment weeks 11 - 13 |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence | Treatment weeks 11-13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shwe Gyaw, MD | National Institute on Drug Abuse (NIDA) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Treatment and Research Center | La Jolla | California | 92307 | United States | ||
| Matrix Institute on Addictions |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lorcaserin | 10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule |
| FG001 | Placebo Oral Capsule | 10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2017 |
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| Placebo Oral Capsule | Drug | sugar pill to mimic lorcaserin 10mg capsule |
|
| Los Angeles |
| California |
| 90016 |
| United States |
| Pharmacology Research Institute | Newport Beach | California | 92660-2452 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
| Meridien Research | Lakeland | Florida | 33805 | United States |
| Behavioral Clinical Research, Inc. | North Miami | Florida | 33161 | United States |
| Boston University School of Medicine | Boston | Massachusetts | 02118-2391 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Neuro-Behavioral Clinical Research Inc. | Canton | Ohio | 44718 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45229 | United States |
| CODA, Inc. | Portland | Oregon | 97214 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The "Intent-to-Treat (ITT) Population" of 272 are all subjects who may have taken at least one dose of lorcaserin or placebo after randomization.
2) The "PPEE Population" of 242 is the subset of the ITT Population who pre-qualify for the primary efficacy endpoint by meeting the specified PPEE criteria prior to randomization
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| ID | Title | Description |
|---|---|---|
| BG000 | Lorcaserin | 10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule |
| BG001 | Placebo Oral Capsule | 10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment in the "Pre-qualified for Primary Efficacy Endpoint" (PPEE) Population | Self-report data indicating no cocaine use on each day of the 3-week period, at least one benzoylecgonine (BE) assay result for a urine sample collect within the 3-weeks period and BE assay results are negative for all urine samples collected during the 3-week period. | Posted | Number | participants | Treatment weeks 11 - 13 |
|
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| ||||||||||||||||||||||||||||||
| Secondary | The Secondary Endpoint is the Actual Number of Subjects That Successfully Achieve Abstinence From Cocaine During the Last Three Weeks of Treatment Who Are Either Non-Drinkers or Who Are Attempting Alcohol Abstinence | Posted | Number | participants | Treatment weeks 11-13 |
|
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Adverse event data were collected every week during treatment and through study follow-up, a 13-week treatment phase with a 4-week follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lorcaserin | 10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule | 0 | 118 | 4 | 118 | 66 | 118 |
| EG001 | Placebo Oral Capsule | 10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule | 0 | 124 | 6 | 124 | 69 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
| ||
| Life threatening and hospitalization | Cardiac disorders | Systematic Assessment |
| ||
| Life threatening and hospitalization | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure increase/decrease | Investigations | Systematic Assessment |
| ||
| Abdominal Distress | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
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| Body pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Depression/Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bodily injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David McCann, Ph.D. | National Institute on Drug Abuse | 301-827-5934 | dmccann@nida.nih.gov |
| Jun 2, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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