A Phase 1 interventional study of Lorcaserin and Placebo in Cocaine Abuse, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-11.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 1, Interventional, and Diagnostic
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).
415 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 312 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
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 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
10 mg 2 times per day from Day 3 to 9 and one time on Day 10
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
Number of Participants with Adverse Events
Time frame: From intake (day -3) through follow-up (day 26)
Number of Participants with Cardiovascular Responses
Time frame: From screening (day -28 through day -4) through follow-up (day 26)
Number of Participants with an Change in the Pharmacokinetics (PK) of Cocaine by Measuring the Cocaine Concentration in Plasma
Time frame: Day 4, 6, 8 through 12
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Abuse (NIDA)