Trial · NCT03007394

Lorcaserin in the Treatment of Cocaine Use Disorder

NCT03007394, Phase 2, Completed, National Institute on Drug Abuse (NIDA); results first posted 2020-06-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lorcaserin in the Treatment of Cocaine Use Disorder. Trials, record NCT03007394. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03007394

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lorcaserin in the Treatment of Cocaine Use Disorder
NCT number: NCT03007394
Status: Completed
Phases: Phase 2
Enrollment: 272 participants, actual
Lead sponsor: National Institute on Drug Abuse (NIDA)
Conditions: Cocaine-Related Disorders
Interventions: Lorcaserin, Placebo Oral Capsule
First posted: 2017-01-02
Last updated: 2020-08-05
Results first posted: 2020-06-19

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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	Treatment weeks 11 - 13	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.
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	Treatment weeks 11-13

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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	Treatment weeks 11 - 13		participants	NUMBER
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	Treatment weeks 11-13		participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
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	Lorcaserin	1	participants
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	Placebo Oral Capsule	4	participants
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	Lorcaserin	0	participants
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	Placebo Oral Capsule	3	participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lorcaserin	118
Overall Study	STARTED	Placebo Oral Capsule	154
Overall Study	COMPLETED	Lorcaserin	91
Overall Study	COMPLETED	Placebo Oral Capsule	91
Overall Study	NOT COMPLETED	Lorcaserin	27
Overall Study	NOT COMPLETED	Placebo Oral Capsule	63

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Blood pressure increase/decrease	Investigations	Lorcaserin	14	118
other	Blood pressure increase/decrease	Investigations	Placebo Oral Capsule	19	124
other	Abdominal Distress	Gastrointestinal disorders	Lorcaserin	20	118
other	Abdominal Distress	Gastrointestinal disorders	Placebo Oral Capsule	18	124
other	Infection	Infections and infestations	Lorcaserin	16	118
other	Infection	Infections and infestations	Placebo Oral Capsule	21	124
other	Headache	Nervous system disorders	Lorcaserin	19	118
other	Headache	Nervous system disorders	Placebo Oral Capsule	13	124
other	Body pain	Musculoskeletal and connective tissue disorders	Lorcaserin	8	118
other	Body pain	Musculoskeletal and connective tissue disorders	Placebo Oral Capsule	18	124

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lorcaserin	0	118
Total, all-cause mortality	Placebo Oral Capsule	0	124
Total, other adverse events	Lorcaserin	66	118
Total, other adverse events	Placebo Oral Capsule	69	124
Total, serious adverse events	Lorcaserin	4	118
Total, serious adverse events	Placebo Oral Capsule	6	124

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Lorcaserin vs Placebo Oral Capsule: 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	Trial comparisons
Lorcaserin vs Placebo Oral Capsule: 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	Trial comparisons
Lorcaserin vs Placebo Oral Capsule: deaths from any cause	Trial comparisons
Lorcaserin vs Placebo Oral Capsule: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03007394

GET https://conductscience.org/api/trials/v1/NCT03007394/events?page=2

API reference For AI assistants