Trial Outcomes & Findings for Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder (NCT NCT02537873)
NCT ID: NCT02537873
Last Updated: 2020-05-12
Results Overview
Change in Heart rate (HR) measures during saline infusions will be compared to HR and BP after each cocaine infusion.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
29 participants
Primary outcome timeframe
Baseline to up to 5 hours on up to day 12 of the study
Results posted on
2020-05-12
Participant Flow
29 participants enrolled and passed screening. 4 withdrew or were terminated prior to randomization resulting in 25 randomized participants.
Participant milestones
| Measure |
Arm 1: Lorcaserin and Cocaine IV
Test Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.
Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
|
Arm 2: Placebo Comparator and Cocaine IV
Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Placebo comparator: Dextrose in gelatin capsule
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
8
|
|
Overall Study
COMPLETED
|
9
|
4
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug Interaction and Self Administration Studies of Compounds for Cocaine Use Disorder
Baseline characteristics by cohort
| Measure |
Arm 1: Lorcaserin and Cocaine IV
n=9 Participants
Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.
Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
|
Arm 2: Placebo Comparator and Cocaine IV
n=4 Participants
Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Placebo comparator: Dextrose in gelatin capsule
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.78 years
STANDARD_DEVIATION 5.29 • n=99 Participants
|
56.25 years
STANDARD_DEVIATION 2.06 • n=107 Participants
|
50.85 years
STANDARD_DEVIATION 6.61 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
4 participants
n=107 Participants
|
13 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 5 hours on up to day 12 of the studyChange in Heart rate (HR) measures during saline infusions will be compared to HR and BP after each cocaine infusion.
Outcome measures
| Measure |
Arm 1: Lorcaserin and Cocaine IV
n=9 Participants
Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.
Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
|
Arm 2: Placebo Comparator and Cocaine IV
n=4 Participants
Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Placebo comparator: Dextrose in gelatin capsule
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) - Heart Rate
|
7.8 beats per minute
Standard Deviation 7.98
|
4.96 beats per minute
Standard Deviation 6.94
|
PRIMARY outcome
Timeframe: 13 daysDuring a study visit 13 days after participant enrollment, participants will be allowed to choose to receive an infusion of cocaine or $5. Number of times participants self-administered Cocaine over an approximately 2 1/2 hour period in the morning and in the afternoon will be counted.
Outcome measures
| Measure |
Arm 1: Lorcaserin and Cocaine IV
n=9 Participants
Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.
Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
|
Arm 2: Placebo Comparator and Cocaine IV
n=4 Participants
Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Placebo comparator: Dextrose in gelatin capsule
|
|---|---|---|
|
Cocaine Self-administration Choice Selection
morning self-administration
|
2.125 cocaine infusions
Standard Deviation 2.03
|
2.2 cocaine infusions
Standard Deviation 2.28
|
|
Cocaine Self-administration Choice Selection
afternoon self-administration
|
0.4 cocaine infusions
Standard Deviation 0.89
|
4.66 cocaine infusions
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: Day 12, pre-infusion to post-infusion (up to 5 hours)During a study visit, participants will be given an infusion of cocaine. Participants will rate their subjective craving for cocaine on a visual analog scale. The scale is rated from Not at all to Extremely. Scores are calculated by measuring in centimeters from Not at all (0) to where the participant marked with the highest score being 100. Participants will rate their subjective experience at baseline (prior to drug infusion) and after cocaine infusion.
Outcome measures
| Measure |
Arm 1: Lorcaserin and Cocaine IV
n=9 Participants
Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.
Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
|
Arm 2: Placebo Comparator and Cocaine IV
n=4 Participants
Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Placebo comparator: Dextrose in gelatin capsule
|
|---|---|---|
|
Change in Subjective Experience
|
1.4 Centimeters
Standard Deviation 8.5
|
1.33 Centimeters
Standard Deviation 1.52
|
PRIMARY outcome
Timeframe: 2 daysRegardless of randomization category, all participants will receive the placebo on days 1 and 2 in a single blind fashion. Plasma concentration-time profiles of cocaine after cocaine infusion during placebo administration (Day 2) will be analyzed to determine how many participant's pharmacokinetic (PK) parameter estimates after using cocaine differ from expected PK parameter estimates for a typical individual using cocaine.
Outcome measures
| Measure |
Arm 1: Lorcaserin and Cocaine IV
n=9 Participants
Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.
Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
|
Arm 2: Placebo Comparator and Cocaine IV
n=4 Participants
Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Placebo comparator: Dextrose in gelatin capsule
|
|---|---|---|
|
Cocaine PK With Placebo
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 12Plasma concentration-time profiles of cocaine after cocaine infusion during study drug (Lorcaserin or placebo) administration (Day 12) will be analyzed to determine how many participant's pharmacokinetic (PK) parameter estimates after using cocaine differ from expected PK parameter estimates for a typical individual using cocaine.
Outcome measures
| Measure |
Arm 1: Lorcaserin and Cocaine IV
n=9 Participants
Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.
Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
|
Arm 2: Placebo Comparator and Cocaine IV
n=4 Participants
Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Placebo comparator: Dextrose in gelatin capsule
|
|---|---|---|
|
Cocaine PK With Study Drug
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 12, baseline to final cocaine infusion (approximately 5 hours)Change in blood pressure (BP) measures during saline infusions will be compared to HR and BP after each cocaine infusion.
Outcome measures
| Measure |
Arm 1: Lorcaserin and Cocaine IV
n=9 Participants
Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.
Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
|
Arm 2: Placebo Comparator and Cocaine IV
n=4 Participants
Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Placebo comparator: Dextrose in gelatin capsule
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) - Change in Blood Pressure
Diastolic BP
|
0.4 mmHg
Standard Deviation 6.65
|
3.54 mmHg
Standard Deviation 4.79
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) - Change in Blood Pressure
Systolic Blood Pressure (BP)
|
6.2 mmHg
Standard Deviation 4.55
|
4.27 mmHg
Standard Deviation 11.28
|
SECONDARY outcome
Timeframe: 3 days (Study days 1, 8, 11)Population: Data was not collected
Commission errors on the IMT (Immediate Memory Task) will be compared between lorcaserin and placebo subjects to determine the extent to which this measure is modified by the administration of lorcaserin using repeated measures ANOVA.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Lorcaserin and Cocaine IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2: Placebo Comparator and Cocaine IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Lorcaserin and Cocaine IV
n=9 participants at risk
Lorcaserin 10 mg administered orally once daily for 6 days then increasing to twice daily for 3 days.
Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Lorcaserin: Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
|
Arm 2: Placebo Comparator and Cocaine IV
n=4 participants at risk
Dextrose placebo in gelatin capsule identical to experimental drug. Cocaine IV (intravenous) administered in ascending doses of 0, 10, 20, 40 mg on study days 1, 2, 6 and 12.
Cocaine Intravenous (IV): Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
Placebo comparator: Dextrose in gelatin capsule
|
|---|---|---|
|
Cardiac disorders
QTc prolongation
|
11.1%
1/9 • Number of events 1 • 19 days - from 1st study visit to final follow-up.
Adverse Events (AEs) will be identified through daily interviews with participants and noted at any visit.
|
0.00%
0/4 • 19 days - from 1st study visit to final follow-up.
Adverse Events (AEs) will be identified through daily interviews with participants and noted at any visit.
|
|
Cardiac disorders
chest tightness
|
11.1%
1/9 • Number of events 1 • 19 days - from 1st study visit to final follow-up.
Adverse Events (AEs) will be identified through daily interviews with participants and noted at any visit.
|
0.00%
0/4 • 19 days - from 1st study visit to final follow-up.
Adverse Events (AEs) will be identified through daily interviews with participants and noted at any visit.
|
Additional Information
F. Gerard Moeller, M.D.
Virginia Commonwealth University
Phone: 804-628-7788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place