Cocaine-Related Disorders
Conditions
Keywords
Cocaine Use Disorder
Brief summary
The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.
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.
Interventions
DRUGLorcaserin
Lorcaserin Capsule
DRUGPlacebo Oral Capsule
sugar pill to mimic lorcaserin 10mg capsule
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lorcaserin 10 mg capsule by mouth, twice a day, for 13 weeks
Lorcaserin: Lorcaserin Capsule | 118 |
| Placebo Oral Capsule 10 mg placebo capsule, twice a day, for 13 weeks
Placebo Oral Capsule: sugar pill to mimic lorcaserin 10mg capsule | 124 |
| Total | 242 |
Baseline characteristics
| Characteristic | Lorcaserin | Placebo Oral Capsule | Total |
|---|---|---|---|
| Age, Continuous | 50.0 years STANDARD_DEVIATION 9.88 | 50.3 years STANDARD_DEVIATION 9.99 | 50.2 years STANDARD_DEVIATION 9.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 10 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants | 113 Participants | 222 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 77 Participants | 83 Participants | 160 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 9 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 35 Participants | 30 Participants | 65 Participants |
| Region of Enrollment United States | 118 participants | 124 participants | 242 participants |
| Sex: Female, Male Female | 28 Participants | 40 Participants | 68 Participants |
| Sex: Female, Male Male | 90 Participants | 84 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 124 |
| other Total, other adverse events | 66 / 118 | 69 / 124 |
| serious Total, serious adverse events | 4 / 118 | 6 / 124 |
Outcome results
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.
Time frame: Treatment weeks 11 - 13
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lorcaserin | 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 |
| 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 | 4 participants |
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
Time frame: Treatment weeks 11-13
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lorcaserin | 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 |
| 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 | 3 participants |