Lorcaserin in the Treatment of Cocaine Use Disorder

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT03007394
• Collaborator: (none)
• Enrollment: 272
• Locations: 12
• Arms: 2
• Actual Duration (Months): 23.4
• Patients Per Site: 22.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.

Condition or Disease	Intervention/Treatment	Phase
Cocaine-Related Disorders	Drug: Lorcaserin; Drug: Placebo Oral Capsule	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 272 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Phase 2, Multi-Center Trial of Lorcaserin in the Treatment of Cocaine Use Disorder
• Actual Study Start Date: Dec 19, 2017
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lorcaserin 10 mg capsule by mouth, twice a day, for 13 weeks	Drug: Lorcaserin; Lorcaserin Capsule; Other Names: Belviq lorcaserin hydrochloride
Placebo Comparator: Placebo Oral Capsule 10 mg placebo capsule, twice a day, for 13 weeks	Drug: Placebo Oral Capsule; sugar pill to mimic lorcaserin 10mg capsule

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured Clinical Interview for DSM-5

• Is seeking treatment for cocaine use disorder

• Is able to understand and provide written informed consent

• Has used cocaine on at least 1 day in the last 30 days prior to screening

• Has completed all psychological assessments and procedures during the screening period

• If female, not pregnant, lactating, unable to conceive OR must agree to use an acceptable method of birth control

• Has a total body weight greater than 110 pounds and body mass index greater than 20

Exclusion Criteria:

• Contact site for more information

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Treatment and Research Center	La Jolla	California	United States	92307
2	Matrix Institute on Addictions	Los Angeles	California	United States	90016
3	Pharmacology Research Institute	Newport Beach	California	United States	92660-2452
4	George Washington University	Washington	District of Columbia	United States	20052
5	Meridien Research	Lakeland	Florida	United States	33805
6	Behavioral Clinical Research, Inc.	North Miami	Florida	United States	33161
7	Boston University School of Medicine	Boston	Massachusetts	United States	02118-2391
8	Altea Research Institute	Las Vegas	Nevada	United States	89102
9	Hassman Research Institute	Berlin	New Jersey	United States	08009
10	Neuro-Behavioral Clinical Research Inc.	Canton	Ohio	United States	44718
11	University of Cincinnati	Cincinnati	Ohio	United States	45229
12	CODA, Inc.	Portland	Oregon	United States	97214

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)

Investigators

• Study Chair: Shwe Gyaw, MD, National Institute on Drug Abuse (NIDA)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 17, 2017

More Information

Publications

None provided.

• Responsible Party: National Institute on Drug Abuse (NIDA)
• ClinicalTrials.gov Identifier: NCT03007394
• Other Study ID Numbers: NIDA/VACSP #1033
• First Posted: Jan 2, 2017
• Last Update Posted: Aug 5, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Institute on Drug Abuse (NIDA): Cocaine Use Disorder
• Additional relevant MeSH terms: Disease; Cocaine-Related Disorders

Study Results

Participant Flow

Arm/Group Title	Lorcaserin	Placebo Oral Capsule
Arm/Group Description	10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule	10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule
Period Title: Overall Study
STARTED	118	154
COMPLETED	91	91
NOT COMPLETED	27	63

Baseline Characteristics

Arm/Group Title	Lorcaserin	Placebo Oral Capsule	Total
Arm/Group Description	10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule	10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule	Total of all reporting groups
Overall Participants	118	124	242
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.0 (9.88)	50.3 (9.99)	50.2 (9.92)
Sex: Female, Male (Count of Participants)
Female	28 23.7%	40 32.3%	68 28.1%
Male	90 76.3%	84 67.7%	174 71.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 6.8%	10 8.1%	18 7.4%
Not Hispanic or Latino	109 92.4%	113 91.1%	222 91.7%
Unknown or Not Reported	1 0.8%	1 0.8%	2 0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.8%	0 0%	1 0.4%
Asian	0 0%	1 0.8%	1 0.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	77 65.3%	83 66.9%	160 66.1%
White	35 29.7%	30 24.2%	65 26.9%
More than one race	4 3.4%	9 7.3%	13 5.4%
Unknown or Not Reported	1 0.8%	1 0.8%	2 0.8%
Region of Enrollment (participants) [Number]
United States	118 100%	124 100%	242 100%

Outcome Measures

1. Primary Outcome

Title	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
Description	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.
Time Frame	Treatment weeks 11 - 13

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lorcaserin	Placebo Oral Capsule
Arm/Group Description	10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule	10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule
Measure Participants	118	124
Number [participants]	1 0.8%	4 3.2%

2. Secondary Outcome

Title	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
Time Frame	Treatment weeks 11-13

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lorcaserin	Placebo Oral Capsule
Arm/Group Description	10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule	10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule
Measure Participants	118	124
Number [participants]	0 0%	3 2.4%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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. 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
Arm/Group Title	Lorcaserin		Placebo Oral Capsule
Arm/Group Description	10 mg capsule by mouth, twice a day, for 13 weeks Lorcaserin: Lorcaserin Capsule		10 mg placebo capsule, twice a day, for 13 weeks Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule
All Cause Mortality
	Lorcaserin		Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/118 (0%)		0/124 (0%)
Serious Adverse Events
	Lorcaserin		Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/118 (3.4%)		6/124 (4.8%)
Cardiac disorders
Life threatening and hospitalization	1/118 (0.8%)		0/124 (0%)
Gastrointestinal disorders
Life threatening and hospitalization	1/118 (0.8%)		0/124 (0%)
General disorders
Hospitalization	2/118 (1.7%)		6/124 (4.8%)
Other (Not Including Serious) Adverse Events
	Lorcaserin		Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	66/118 (55.9%)		69/124 (55.6%)
Gastrointestinal disorders
Abdominal Distress	20/118 (16.9%)		18/124 (14.5%)
General disorders
Fatigue	13/118 (11%)		13/124 (10.5%)
Infections and infestations
Infection	16/118 (13.6%)		21/124 (16.9%)
Injury, poisoning and procedural complications
Bodily injury	8/118 (6.8%)		8/124 (6.5%)
Investigations
Blood pressure increase/decrease	14/118 (11.9%)		19/124 (15.3%)
Musculoskeletal and connective tissue disorders
Body pain	8/118 (6.8%)		18/124 (14.5%)
Nervous system disorders
Headache	19/118 (16.1%)		13/124 (10.5%)
Psychiatric disorders
Depression/Anxiety	16/118 (13.6%)		11/124 (8.9%)
Skin and subcutaneous tissue disorders
Rash	11/118 (9.3%)		7/124 (5.6%)
Vascular disorders
Hypertension	4/118 (3.4%)		4/124 (3.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.