Trial Outcomes & Findings for Lorcaserin in the Treatment of Cocaine Use Disorder (NCT NCT03007394)

Last Updated: 2020-08-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

272 participants

Primary outcome timeframe

Treatment weeks 11 - 13

Results posted on

2020-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	Lorcaserin 10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule	Placebo Oral Capsule 10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule
Overall Study STARTED	118	154
Overall Study COMPLETED	91	91
Overall Study NOT COMPLETED	27	63

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lorcaserin in the Treatment of Cocaine Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lorcaserin n=118 Participants 10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule	Placebo Oral Capsule n=124 Participants 10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule	Total n=242 Participants Total of all reporting groups
Age, Continuous	50.0 years STANDARD_DEVIATION 9.88 • n=5 Participants	50.3 years STANDARD_DEVIATION 9.99 • n=7 Participants	50.2 years STANDARD_DEVIATION 9.92 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	40 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	90 Participants n=5 Participants	84 Participants n=7 Participants	174 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	109 Participants n=5 Participants	113 Participants n=7 Participants	222 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	77 Participants n=5 Participants	83 Participants n=7 Participants	160 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	30 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	118 participants n=5 Participants	124 participants n=7 Participants	242 participants n=5 Participants

PRIMARY outcome

Timeframe: Treatment weeks 11 - 13

Outcome measures

Outcome measures
Measure	Lorcaserin n=118 Participants 10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule	Placebo Oral Capsule n=124 Participants 10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg 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	1 participants	4 participants

SECONDARY outcome

Timeframe: Treatment weeks 11-13

Outcome measures

Outcome measures
Measure	Lorcaserin n=118 Participants 10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule	Placebo Oral Capsule n=124 Participants 10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg 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	0 participants	3 participants

Adverse Events

Lorcaserin

Serious events: 4 serious events

Other events: 66 other events

Deaths: 0 deaths

Placebo Oral Capsule

Serious events: 6 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lorcaserin n=118 participants at risk 10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule	Placebo Oral Capsule n=124 participants at risk 10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule
General disorders Hospitalization	1.7% 2/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	4.8% 6/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
Cardiac disorders Life threatening and hospitalization	0.85% 1/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	0.00% 0/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
Gastrointestinal disorders Life threatening and hospitalization	0.85% 1/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	0.00% 0/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here

Other adverse events

Other adverse events
Measure	Lorcaserin n=118 participants at risk 10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule	Placebo Oral Capsule n=124 participants at risk 10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule
Investigations Blood pressure increase/decrease	11.9% 14/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	15.3% 19/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
Gastrointestinal disorders Abdominal Distress	16.9% 20/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	14.5% 18/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
Infections and infestations Infection	13.6% 16/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	16.9% 21/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
Nervous system disorders Headache	16.1% 19/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	10.5% 13/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
Musculoskeletal and connective tissue disorders Body pain	6.8% 8/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	14.5% 18/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
Psychiatric disorders Depression/Anxiety	13.6% 16/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	8.9% 11/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
General disorders Fatigue	11.0% 13/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	10.5% 13/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
Skin and subcutaneous tissue disorders Rash	9.3% 11/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	5.6% 7/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
Injury, poisoning and procedural complications Bodily injury	6.8% 8/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	6.5% 8/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here
Vascular disorders Hypertension	3.4% 4/118 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here	3.2% 4/124 • 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. 1. 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 as noted in the total for the participant flow. 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, which is the subset population used here

Additional Information

David McCann, Ph.D.

National Institute on Drug Abuse

Phone: 301-827-5934

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60