Study to Assess Potential Interactions Between Intravenous Cocaine and Oral Lorcaserin

NCT02393599 | Completed Phase 1

• 1 other identifier: Lorcaserin-Phase 1b-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Cocaine Abuse

Outcome Measures

Primary Outcomes (2)

• 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 (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

Study Arms (2)

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

Lorcaserin DRUG

10 mg 2 times per day from Day 3 to 9 and one time on Day 10

Lorcaserin

Placebo DRUG

10 mg 2 times per day from Day 3 to 9 and one time on Day 10

Placebo

Cocaine Infusion DRUG

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

Lorcaserin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• diaphragm and condom by partner
• condom and spermicide by partner
• intrauterine device and condom by partner
• sponge and condom by partner
• complete abstinence from sexual intercourse
• 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.

You may not qualify if:

• Please contact site directly for more information

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Vince Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Debra Kelsh, Ph.D.

  Vince & Associates Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 19, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 11, 2017

Record last verified: 2015-10

Locations

US (1)