Table 1.
Study procedures.
| Study day(s) | Study drug dosingʈ | Morning procedures | Afternoon procedures |
|---|---|---|---|
| Study Day 1 (Inpatient) |
Placebo (8 a.m.) | - Three screening doses of cocaine (testing for tolerability) | None |
| Study Day 2 (Inpatient) |
Placebo (8 a.m.) Placebo (8 p.m.) |
- 10 mg cocaine for PK measures | - Three doses of cocaine - Baseline cardiovascular measures - Subjective ratings (VAS) |
| Study Day 3 (Inpatient) |
Placebo (8 a.m.) Lorcaserin 10 mg OR Placebo (8 p.m.) |
- VAS - Cocaine self-administration session (baseline) |
- VAS - Cocaine self-administration session (baseline) |
|
*Study Days 4 and 5 (Outpatient) |
Placebo (8 a.m.), Lorcaserin (8 p.m.) OR Placebo (8 a.m.), Placebo (8 p.m.) |
- Outpatient medication and check-in visit | None |
| Study Day 6 (Inpatient) |
Placebo (8 a.m.), Lorcaserin (8 p.m.) OR Placebo (8 a.m.), Placebo (8 p.m.) |
- 10 mg Cocaine for PK, lorcaserin blood levels | - Three Doses of Cocaine - Cardiovascular measures - Subjective Ratings (VAS) |
| Study Day 7 (Inpatient) |
Placebo (8 a.m.), Lorcaserin (8 p.m.) OR Placebo (8 a.m.), Placebo (8 p.m.) |
- Cocaine self-administration session | - Cocaine self-administration session - Impulsivity Testing |
|
*Study Days 8 and 9 (Outpatient) |
Lorcaserin (8 a.m.), Lorcaserin (8 p.m.) OR Placebo (8 a.m.), Placebo (8 p.m.) |
- Outpatient medication and check-in visit, | None |
| Study Day 10 (Inpatient) |
Lorcaserin (8 a.m.), Lorcaserin (8 p.m.) OR Placebo (8 a.m.), Placebo (8 p.m.) |
- 10 mg cocaine for PK, lorcaserin blood levels | - Three doses of cocaine - Cardiovascular measures - Subjective Ratings (VAS) - Impulsivity Testing |
| Study Day 11 (Inpatient) |
Lorcaserin (8 a.m.), Lorcaserin (8 p.m.) OR Placebo (8 a.m.), Placebo (8 p.m.) |
- Cocaine self-administration session | - Cocaine Self Administration |
| Study Day 12 (Inpatient) |
None | - Impulsivity Testing | Physical exam |
| Study Days 15–19 (Outpatient) |
None | - Physical exam (Day 19 only) |
All study visits (inpatient and outpatient) included vitals, UDS, and ECG. Inpatient visits also included physical exam and continuous cardiovascular monitoring.
ʈ
Medication on study days 3–11 based on study drug randomization assignment (Lorcaserin or placebo).
*
On these days the AM medication dose taken at visit, and PM dose provided with instructions to take at home at 8 p.m.