Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT02393599
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

The primary objective of this study is to determine if there are significant interactions between oral lorcaserin treatment concurrent with 20 and 40 mg intravenous (i.v.) cocaine infusions by measuring adverse events (AEs) and cardiovascular responses including heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) (including QTc).

Condition or Disease	Intervention/Treatment	Phase
Cocaine Abuse	Drug: Lorcaserin; Drug: Placebo; Drug: Cocaine Infusion	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Phase 1, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lorcaserin Lorcaserin (10mg) will be administered 2 times per day from Days 3 to 9 and only one time on Day 10	Drug: Lorcaserin; 10 mg 2 times per day from Day 3 to 9 and one time on Day 10; Drug: Cocaine Infusion; Screening / Session 1, Study Day -2: 20 mg cocaine, followed by a saline infusion, followed by 40 mg cocaine Baseline/ Session 2, Study Day 1: Saline or 20 mg cocaine followed by either 20 mg cocaine or saline Baseline / Session 3, Study Day 2: Saline or 40 mg cocaine followed by either 40 mg cocaine or saline Treatment / Session 4, Study Day 9: Saline or 20 mg cocaine followed by either 20 mg cocaine or saline Treatment / Session 5, Study Day10: Saline or 40 mg cocaine followed by either 40 mg cocaine or saline
Placebo Comparator: Placebo Placebo will be administered 2 times per day from Days 3 to 9 and only one time on Day 10	Drug: Placebo; 10 mg 2 times per day from Day 3 to 9 and one time on Day 10

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Adverse Events [From intake (day -3) through follow-up (day 26)]

2. Number of Participants with Cardiovascular Responses [From screening (day -28 through day -4) through follow-up (day 26)]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vince Associates Clinical Research, Inc.	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Debra Kelsh, Ph.D., Vince & Associates Clinical Research, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Institute on Drug Abuse (NIDA)
• ClinicalTrials.gov Identifier: NCT02393599
• Other Study ID Numbers: Lorcaserin-Phase 1b-001
• First Posted: Mar 19, 2015
• Last Update Posted: Jan 11, 2017
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Cocaine-Related Disorders; Cocaine

Study Results

No Results Posted as of Jan 11, 2017