MedDataX Logo

Trial Outcomes & Findings for Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder (NCT NCT03143855)

NCT ID: NCT03143855

Last Updated: 2020-11-12

Results Overview

Drug liking is measured on a 100 millimeter visual analog rating with one end of the line representing a score of 0 for "not at all" and the other end being a score of 100 or extremely. Participants complete the rating 45 minutes after a 20 mg dose of oxycodone at baseline and after after 5 days of treatment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

Baseline to day 5

Results posted on

2020-11-12

Participant Flow

32 participants signed the consent form however 5 participants were no shows for the initial visit at which ranndomization occurred.

Participant milestones

Participant milestones
Measure
Lorcaserin
Lorcaserin: Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
Control Group
Placebo: Placebo will be administered twice daily for for 5 days
Overall Study
STARTED
17
10
Overall Study
COMPLETED
12
6
Overall Study
NOT COMPLETED
5
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Lorcaserin
Lorcaserin: Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
Control Group
Placebo: Placebo will be administered twice daily for for 5 days
Overall Study
Withdrawal by Subject
4
3
Overall Study
Protocol Violation
1
0
Overall Study
Participant experienced withdrawal
0
1

Baseline Characteristics

Drug Interaction and Subjective Effects of Compounds for Opioid Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Lorcaserin
n=12 Participants
Lorcaserin: Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
Control Group
n=6 Participants
Placebo: Placebo will be administered twice daily for for 5 days
Total
n=18 Participants
Total of all reporting groups
Age, Continuous
49 years
STANDARD_DEVIATION 10.2 • n=5 Participants
46 years
STANDARD_DEVIATION 8.8 • n=7 Participants
48 years
STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
4 Participants
n=7 Participants
15 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
10 Participants
n=5 Participants
5 Participants
n=7 Participants
15 Participants
n=5 Participants
Race (NIH/OMB)
White
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants
6 participants
n=7 Participants
18 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline to day 5

Population: Males and Females between ages 18 and 70 who meet criteria for opioid use disorder, at least moderate severity, but are not seeking treatment. Subjects diagnosed with a current psychiatric disorder or mental disorder including cardiovascular, pulmonary, CNS, hepatic or renal disorder are excluded from participation.

Drug liking is measured on a 100 millimeter visual analog rating with one end of the line representing a score of 0 for "not at all" and the other end being a score of 100 or extremely. Participants complete the rating 45 minutes after a 20 mg dose of oxycodone at baseline and after after 5 days of treatment.

Outcome measures

Outcome measures
Measure
Lorcaserin
n=11 Participants
Lorcaserin: Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
Control Group
n=6 Participants
Placebo: Placebo will be administered twice daily for for 5 days
Change in Subjective Response to Oxycodone Measured With 100 Millimeter Visual Analog Scale
-13.81 units on a scale
Standard Deviation 31.7
-9.67 units on a scale
Standard Deviation 32.6

Adverse Events

Lorcaserin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Lorcaserin
n=12 participants at risk
Lorcaserin: Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
Control Group
n=6 participants at risk
Placebo: Placebo will be administered twice daily for for 5 days
Psychiatric disorders
Emesis
0.00%
0/12 • 5 days
16.7%
1/6 • Number of events 1 • 5 days

Additional Information

Dr. F. Gerard Moeller

Virginia Commonwealth University

Phone: 804-828-4134

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place