Study to Assess Potential Interactions Between Intravenou... | NCT02393599

Studies
Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

NCT02393599

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 11, 2017Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Cocaine Abuse

Interventions

Lorcaserin
Placebo
Cocaine Infusion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Mar 4, 2015

First Submission Date that Met QC Criteria

Mar 13, 2015

First Posted Date

Mar 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2017

Last Update Posted Date

Jan 11, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lorcaserin	Experimental	Lorcaserin (10mg) will be administered 2 times per day from Days 3 to 9 and only one time on Day 10	Drug: Lorcaserin Drug: Cocaine Infusion
Placebo	Placebo Comparator	Placebo will be administered 2 times per day from Days 3 to 9 and only one time on Day 10	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lorcaserin	Drug	10 mg 2 times per day from Day 3 to 9 and one time on Day 10	Lorcaserin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events		From intake (day -3) through follow-up (day 26)
Number of Participants with Cardiovascular Responses		From screening (day -28 through day -4) through follow-up (day 26)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with an Change in the Pharmacokinetics (PK) of Cocaine by Measuring the Cocaine Concentration in Plasma		Day 4, 6, 8 through 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be volunteers who are not seeking treatment for drug addiction.
Be between 18 and 50 years-of-age.
Meet Diagnostic and Statistical Manual (DSM-IV) - Text Revision (TR) criteria for current cocaine abuse as assessed using the MINI neuropsychiatric interview (version 6.0).
Have a body mass index (BMI) within a range of 18.0 to 34.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
Have experience using cocaine by the smoked or i.v. route at least 6 times in the past 12 months prior to clinic intake (Day -3) and at least one use within the past 30 days.
Provide a urine sample positive for cocaine at least once during screening (Days -28 to -4).
Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
Females must have a negative serum pregnancy test at screening and negative urine pregnancy test at intake prior to receiving the first dose of investigational drug. They must also be postmenopausal, have had a hysterectomy, been sterilized, have a partner with a vasectomy, or agree to use one of the following methods of birth control starting at least 14 days prior to clinic intake:
1. diaphragm and condom by partner
2. condom and spermicide by partner
3. intrauterine device and condom by partner
4. sponge and condom by partner
5. complete abstinence from sexual intercourse
6. oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive
Be able to comply with protocol requirements, rules and regulations of the study site and be likely to complete all the study treatments.

Exclusion Criteria:

Please contact site directly for more information

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders